Cataract, Primary Open Angle Glaucoma
Conditions
Brief summary
The purpose of this study is to assess long-term (10 years post-CyPass implantation) status of the corneal endothelium in subjects who were implanted with the CyPass Micro-Stent in the COMPASS trial.
Detailed description
The COMPASS Trial (TMI-09-01/NCT01085357) was a prospective, randomized, comparative multicenter study to assess the safety and effectiveness of the CyPass Micro-Stent in subjects with primary open angle glaucoma who were undergoing cataract surgery. In the COMPASS Trial, 374 subjects undergoing cataract surgery were randomized to the CyPass group and received the CyPass Micro-Stent, whereas 131 subjects underwent cataract surgery alone. All subjects were to be followed for 2 years postoperatively. Four hundred eighty (480) subjects completed this study. The COMPASS XT Trial (TMI-09-01E/GLD122b-C001/NCT02700984) was designed to collect safety data beyond 24 months postoperatively for subjects who completed the COMPASS Trial. In COMPASS-XT, clinical data was collected at 36 months, 48 months, and 60 months postoperatively for a total of 5-year follow-up across the 2 studies. In this trial, COMPASS XXT, clinical data will be collected annually for the subjects who were implanted with the CyPass Micro-Stent in the COMPASS TRIAL until the subject reaches 10 years post-CyPass implantation. For some subjects, the first visit will be at or after 10 years post-CyPass implantation, and therefore the first visit may coincide with the Exit visit.
Interventions
DEVICECyPass Micro-Stent
The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of the eye. The device is implanted after completion of cataract surgery.
PROCEDURECataract Surgery
Cataract surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Implantation with a CyPass Micro-Stent as a participant in the COMPASS trial (NCT01085357) (Transcend Medical, Incorporated, Study Number TMI-09-01). * Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Inability to comply with the protocol or required follow-up visit/procedures. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Sight-threatening Adverse Events (AEs) | Month 96 (Year 8) to Month 120 (Year 10) postoperative | An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). This analysis was performed using data from visits in the COMPASS XXT study and includes sight-threatening adverse events as specified in the protocol. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percentage of Eyes With Ocular Adverse Events | Month 96 (Year 8) to Month 120 (Year 10) postoperative | An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). This analysis was performed using data from visits in the COMPASS XXT study and includes ocular events other than sight-threatening adverse events. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation | Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval | Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | Month 96 (Year 8) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | Month 108 (Year 9) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation | Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval | Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | Month 96 (Year 8) postoperative | Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | Month 108 (Year 9) postoperative | Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | Month 120 (Year 10) postoperative | Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Mean and Standard Deviation | Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) | Month 96 (Year 8) postoperative | The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) | Month 108 (Year 9) postoperative | The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) | Month 120 (Year 10) postoperative | The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Hexagonality (CEH) Reported by Mean and Standard Deviation | Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) | Month 96 (Year 8) postoperative | The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) | Month 108 (Year 9) postoperative | The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) | Month 120 (Year 10) postoperative | The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation | Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval | Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | Baseline (COMPASS Study) preoperative, Month 96 (Year 8) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | Baseline (COMPASS Study) preoperative, Month 108 (Year 9) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | Baseline (COMPASS Study) preoperative, Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation | Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval | Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | Baseline (COMPASS Study) preoperative, Month 96 (Year 8) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | Baseline (COMPASS Study) preoperative, Month 108 (Year 9) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | Baseline (COMPASS Study) preoperative, Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS, COMPASS XT, and COMPASS XXT studies. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS, COMPASS XT, and COMPASS XXT studies. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline | Baseline (COMPASS Study) preoperative, Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS, COMPASS XT, and COMPASS XXT studies. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive annualized rate of change indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative annualized rate of change signifies a decrease in central ECD, which may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive annualized rate of change indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative annualized rate of change signifies a decrease in central ECD, which may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive percent change per year indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative percent change per year may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. Central ECD was measured in cells per millimeter squared. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive percent change per year indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative percent change per year may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. Central ECD was measured in cells per millimeter squared. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Number of Corneal Sequelae Events Associated With Endothelial Cell Loss (ECL) | Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Corneal sequelae are occurrences of complications related to ECL in the cornea and may include corneal edema, decreased visual acuity, corneal decompensation, bullous keratopathy, etc. Corneal sequelae were quantified by counting the instances where patients experienced complications attributable to endothelial cell loss. A higher number of corneal sequelae events may indicate rapid disease progression or inadequate management of conditions leading to endothelial cell loss. A lower number of corneal sequelae events may indicate a favorable response to treatment and successful disease treatment or treatment stabilization. This analysis was performed using data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | Month 3 postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | Month 6 postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | Month 12 (Year 1) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | Month 24 (Year 2) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | Month 36 (Year 3) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | Month 48 (Year 4) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | Month 60 (Year 5) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | Month 96 (Year 8) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | Month 108 (Year 9) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | Month 120 (Year 10) postoperative | Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | Month 96 (Year 8) postoperative | Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | Month 108 (Year 9) postoperative | Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | Month 120 (Year 10) postoperative | Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Number of Secondary Surgical Intervention (SSI) Events to Modify the Device Position (eg, Repositioning, Trimming, Explantation) | Month 96 (Year 8) to Month 120 (Year 10) postoperative | SSI events are additional surgical procedures performed after the initial placement of the CyPass micro-stent device to adjust its position or address issues related to its placement. SSI were noted through adverse event reporting, clinical evaluation, comprehensive documentation of outcome assessment and data analysis. A higher number of SSI events may indicate challenges or complications related to the initial placement of the CyPass device, technical difficulties during the initial surgery, device-related issues, or patient-specific factors contributing to the need for additional interventions. A lower number of SSI events may suggest that the initial device placement was successful and well-tolerated, with fewer complications or the need for adjustments. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percentage of Eyes With CyPass Micro-Stent Movement and/or Malposition | Month 96 (Year 8) to Month 120 (Year 10) postoperative | CyPass micro-stent movement and/or malposition refers to issues related to the displacement or improper positioning of the CyPass Micro-Stent in the eye's drainage angle. The investigator qualitatively and subjectively assessed the position of the device by counting the visible number of rings of the device during a gonioscopic exam, which used a specialized lens to visually assess the position and stability of the CyPass device. Movement and/or malposition may suggest a greater risk of complications or inadequate treatment of glaucoma. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Number of Corneal Adverse Events Caused by CyPass MicroStent | Month 96 (Year 8) to Month 120 (Year 10) postoperative | A corneal adverse event is an undesirable occurrence related to the cornea, such as inflammation, edema, epithelial defects, or other complications. The number of corneal adverse events caused by the CyPass Micro-Stent was assessed from patient reporting, clinical observation and documentation during patients' follow-up visits. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Number of Events of Best Corrected Visual Acuity (BCVA) Loss of 10 Letters or More | Month 96 (Year 8) to Month 120 (Year 10) postoperative | Visual acuity was measured with correction in place using letter charts. BCVA \[synonymous with Best Corrected Distance Visual Acuity (BCDVA)\] at each visit was compared to the participant's best achieved BCVA recorded throughout the 10-year period after CyPass implantation. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported by Mean and Standard Deviation | Screening (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Visual field mean deviation is a measure used in visual field testing to assess the overall sensitivity of a patient's vision compared to a standardized norm. The Humphrey automated perimeter with the 24-2 Swedish Interactive Thresholding Algorithm (SITA) standard testing method was used. Deviations were recorded in decibels. Normal deviation values are typically within 0 to -2 decibels (dB). A more negative number indicates decreased sensitivity and worsening of the overall visual field. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) | Screening (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | Visual field mean deviation is a measure used in visual field testing to assess the overall sensitivity of a patient's vision compared to a standardized norm. The Humphrey automated perimeter with the 24-2 SITA standard testing method was used. Deviations were recorded in decibels. Normal deviation values are typically within 0 to -2 decibels (dB). A more negative number indicates decreased sensitivity and worsening of the overall visual field. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation | Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | CCT is a measurement of the thickness of the cornea at its center and is assessed using a procedure called corneal pachymetry. A high CCT (thick cornea) indicates a central cornea thicker than average and may be associated with conditions such as corneal edema, Fuchs' dystrophy, or ocular hypertension. A low CCT (thin cornea) indicates a central cornea thinner than average and may be a risk factor for developing conditions such as glaucoma. A negative change value indicates a decrease in corneal thickness. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
| Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval | Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative | CCT is a measurement of the thickness of the cornea at its center and is assessed using a procedure called corneal pachymetry. A high CCT (thick cornea) indicates a central cornea thicker than average and may be associated with conditions such as corneal edema, Fuchs' dystrophy, or ocular hypertension. A low CCT (thin cornea) indicates a central cornea thinner than average and may be a risk factor for developing conditions such as glaucoma. A negative change value indicates a decrease in corneal thickness. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 12 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all enrolled participants.
Participants by arm
| Arm | Count |
|---|---|
| Cataract Surgery + CyPass CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial) | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Enrolled in error | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Subject withdrew consent | 3 |
Baseline characteristics
| Characteristic | Cataract Surgery + CyPass |
|---|---|
| Age, Continuous | 78.3 years STANDARD_DEVIATION 6.87 |
| Endothelial Cell Density (ECD) | 2403.93 cells per square millimeter STANDARD_DEVIATION 362.028 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants |
| Race/Ethnicity, Customized \Native Hawaiian or Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 50 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants |
| Race/Ethnicity, Customized White | 48 Participants |
| Region of Enrollment United States | 54 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 1 / 54 |
| other Total, other adverse events | 31 / 54 | 0 / 54 |
| serious Total, serious adverse events | 12 / 54 | 2 / 54 |
Outcome results
Primary
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval
The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive percent change per year indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative percent change per year may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. Central ECD was measured in cells per millimeter squared. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Baseline to Year 1 | -10.15 percent change per year |
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Year 1 to Year 2 | -1.24 percent change per year |
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Year 2 to Year 3 | -4.86 percent change per year |
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Year 3 to Year 4 | -2.72 percent change per year |
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Year 4 to Year 5 | -5.14 percent change per year |
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Year 8 to Year 9 | -8.52 percent change per year |
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Year 9 to Year 10 | -2.82 percent change per year |
Primary
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation
The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive percent change per year indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative percent change per year may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. Central ECD was measured in cells per millimeter squared. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Baseline to Year 1 | -10.15 percent change per year | Standard Deviation 16.78 |
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Year 1 to Year 2 | -1.24 percent change per year | Standard Deviation 9.18 |
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Year 2 to Year 3 | -4.86 percent change per year | Standard Deviation 3.78 |
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Year 3 to Year 4 | -2.72 percent change per year | Standard Deviation 2.446 |
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Year 4 to Year 5 | -5.14 percent change per year | Standard Deviation 9.946 |
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Year 8 to Year 9 | -8.52 percent change per year | Standard Deviation 10.508 |
| Cataract Surgery + CyPass | Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Year 9 to Year 10 | -2.82 percent change per year | Standard Deviation 14.357 |
Primary
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval
The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive annualized rate of change indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative annualized rate of change signifies a decrease in central ECD, which may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Baseline to Year 1 | -267.77 [cells per millimeter squared] per year |
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Year 1 to Year 2 | -23.80 [cells per millimeter squared] per year |
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Year 2 to Year 3 | -118.83 [cells per millimeter squared] per year |
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Year 3 to Year 4 | -63.57 [cells per millimeter squared] per year |
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Year 4 to Year 5 | -95.54 [cells per millimeter squared] per year |
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Year 8 to Year 9 | -138.10 [cells per millimeter squared] per year |
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval | Year 9 to Year 10 | -44.00 [cells per millimeter squared] per year |
Primary
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation
The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive annualized rate of change indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative annualized rate of change signifies a decrease in central ECD, which may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Baseline to Year 1 | -267.77 [cells per millimeter squared] per year | Standard Deviation 405.731 |
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Year 1 to Year 2 | -23.80 [cells per millimeter squared] per year | Standard Deviation 149.533 |
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Year 2 to Year 3 | -118.83 [cells per millimeter squared] per year | Standard Deviation 90.832 |
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Year 3 to Year 4 | -63.57 [cells per millimeter squared] per year | Standard Deviation 57.63 |
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Year 4 to Year 5 | -95.54 [cells per millimeter squared] per year | Standard Deviation 191.951 |
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Year 8 to Year 9 | -138.10 [cells per millimeter squared] per year | Standard Deviation 169.597 |
| Cataract Surgery + CyPass | Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation | Year 9 to Year 10 | -44.00 [cells per millimeter squared] per year | Standard Deviation 221.29 |
Primary
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Mean and Standard Deviation
The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Mean and Standard Deviation | Month 96 (Year 8) | 28.19 unitless | Standard Deviation 3.189 |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Mean and Standard Deviation | Month 108 (Year 9) | 29.25 unitless | Standard Deviation 5.507 |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Mean and Standard Deviation | Month 120 (Year 10) | 30.57 unitless | Standard Deviation 5.001 |
Primary
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9)
The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 108 (Year 9) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) | 0 percentile | 8.0 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) | 5th percentile | 20.5 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) | 25th percentile | 27.0 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) | 50th percentile | 29.4 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) | 75th percentile | 32.2 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) | 95th percentile | 36.3 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) | 100th percentile | 39.5 unitless |
Primary
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10)
The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) | 0 percentile | 16.5 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) | 5th percentile | 21.5 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) | 25th percentile | 27.8 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) | 50th percentile | 30.8 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) | 75th percentile | 33.8 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) | 95th percentile | 38.8 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) | 100th percentile | 40.5 unitless |
Primary
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8)
The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) | 0 percentile | 23.8 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) | 5th percentile | 23.8 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) | 25th percentile | 24.8 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) | 50th percentile | 28.2 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) | 75th percentile | 31.0 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) | 95th percentile | 32.3 unitless |
| Cataract Surgery + CyPass | Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) | 100th percentile | 32.3 unitless |
Primary
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10)
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 3 | 1913.03 cells per millimeter squared | Standard Deviation 583.158 |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 12 (Year 1) | 2000.93 cells per millimeter squared | Standard Deviation 461.735 |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 108 (Year 9) | 1894.88 cells per millimeter squared | Standard Deviation 639.384 |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 96 (Year 8) | 1660.70 cells per millimeter squared | — |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 60 (Year 5) | 2292.05 cells per millimeter squared | Standard Deviation 381.087 |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 6 | 1769.03 cells per millimeter squared | Standard Deviation 624.608 |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 120 (Year 10) | 1897.05 cells per millimeter squared | Standard Deviation 730.546 |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 48 (Year 4) | 2062.20 cells per millimeter squared | Standard Deviation 364.44 |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 24 (Year 2) | 1938.18 cells per millimeter squared | Standard Deviation 529.916 |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 12 (Year 1) | 1756.30 cells per millimeter squared | — |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 6 | 2394.50 cells per millimeter squared | — |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 24 (Year 2) | 2449.60 cells per millimeter squared | Standard Deviation 70.295 |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 48 (Year 4) | 2555.70 cells per millimeter squared | — |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 60 (Year 5) | 2342.00 cells per millimeter squared | Standard Deviation 27.577 |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 96 (Year 8) | 1412.50 cells per millimeter squared | — |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 108 (Year 9) | 1735.63 cells per millimeter squared | Standard Deviation 232.046 |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 120 (Year 10) | 1663.71 cells per millimeter squared | Standard Deviation 593.233 |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 48 (Year 4) | 2307.67 cells per millimeter squared | Standard Deviation 280.27 |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 12 (Year 1) | 2272.34 cells per millimeter squared | Standard Deviation 345.825 |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 120 (Year 10) | 1941.97 cells per millimeter squared | Standard Deviation 661.397 |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 60 (Year 5) | 2159.78 cells per millimeter squared | Standard Deviation 375.998 |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 108 (Year 9) | 2049.77 cells per millimeter squared | Standard Deviation 585.452 |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 96 (Year 8) | 2185.30 cells per millimeter squared | — |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 36 (Year 3) | 2324.50 cells per millimeter squared | — |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 24 (Year 2) | 2189.33 cells per millimeter squared | Standard Deviation 388.648 |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 6 | 2206.81 cells per millimeter squared | Standard Deviation 383.001 |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 3 | 2159.24 cells per millimeter squared | Standard Deviation 467.711 |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 6 | 2226.18 cells per millimeter squared | Standard Deviation 324.459 |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 24 (Year 2) | 2144.41 cells per millimeter squared | Standard Deviation 400.509 |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 36 (Year 3) | 2338.00 cells per millimeter squared | Standard Deviation 199.121 |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 48 (Year 4) | 2117.21 cells per millimeter squared | Standard Deviation 301.552 |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 60 (Year 5) | 2016.68 cells per millimeter squared | Standard Deviation 495.751 |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 96 (Year 8) | 2209.60 cells per millimeter squared | Standard Deviation 354.119 |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 3 | 2154.11 cells per millimeter squared | Standard Deviation 309.015 |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 120 (Year 10) | 1486.70 cells per millimeter squared | Standard Deviation 721.315 |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 108 (Year 9) | 1720.05 cells per millimeter squared | Standard Deviation 740.783 |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 12 (Year 1) | 2261.04 cells per millimeter squared | Standard Deviation 394.756 |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 3 | 2368.27 cells per millimeter squared | Standard Deviation 306.424 |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 24 (Year 2) | 2186.23 cells per millimeter squared | Standard Deviation 362.508 |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 12 (Year 1) | 2139.71 cells per millimeter squared | Standard Deviation 307.753 |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 120 (Year 10) | 924.90 cells per millimeter squared | Standard Deviation 421.601 |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 60 (Year 5) | 1645.16 cells per millimeter squared | Standard Deviation 433.827 |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 48 (Year 4) | 1616.86 cells per millimeter squared | Standard Deviation 601.855 |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 6 | 2160.54 cells per millimeter squared | Standard Deviation 309.941 |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 96 (Year 8) | 1469.85 cells per millimeter squared | Standard Deviation 792.172 |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 108 (Year 9) | 925.40 cells per millimeter squared | Standard Deviation 401.25 |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 24 (Year 2) | 1309.70 cells per millimeter squared | Standard Deviation 870.024 |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 6 | 2012.45 cells per millimeter squared | Standard Deviation 66.256 |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 48 (Year 4) | 742.00 cells per millimeter squared | Standard Deviation 36.062 |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 3 | 2035.25 cells per millimeter squared | Standard Deviation 7.707 |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 12 (Year 1) | 1492.95 cells per millimeter squared | Standard Deviation 293.379 |
Primary
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 108 (Year 9) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 0 percentile | 547.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 25th percentile | 1612.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 100th percentile | 2573.2 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 5th percentile | 547.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 95th percentile | 2573.2 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 75th percentile | 2222.8 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 50th percentile | 2180.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 0 percentile | 1438.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 95th percentile | 2003.8 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 5th percentile | 1438.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 75th percentile | 1887.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 25th percentile | 1583.6 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 100th percentile | 2003.8 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 50th percentile | 1750.1 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 0 percentile | 699.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 95th percentile | 2660.8 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 75th percentile | 2362.5 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 50th percentile | 2217.2 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 5th percentile | 699.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 100th percentile | 2660.8 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 25th percentile | 2131.3 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 25th percentile | 805.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 100th percentile | 2546.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 5th percentile | 458.8 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 95th percentile | 2546.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 50th percentile | 2014.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 75th percentile | 2301.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 0 percentile | 458.8 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 100th percentile | 1674.8 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 0 percentile | 568.3 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 5th percentile | 568.3 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 50th percentile | 783.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 75th percentile | 1057.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 95th percentile | 1674.8 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 25th percentile | 684.3 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 0 percentile | 483.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 100th percentile | 2597.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 95th percentile | 2597.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 25th percentile | 1881.9 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 5th percentile | 483.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 50th percentile | 2121.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 75th percentile | 2177.4 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 75th percentile | 2102.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 50th percentile | 1849.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 5th percentile | 796.6 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 0 percentile | 796.6 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 95th percentile | 2363.3 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 25th percentile | 951.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 100th percentile | 2363.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 50th percentile | 2165.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 0 percentile | 624.7 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 5th percentile | 624.7 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 25th percentile | 1503.2 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 75th percentile | 2359.1 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 95th percentile | 2800.8 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 100th percentile | 2800.8 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 25th percentile | 782.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 75th percentile | 1960.5 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 5th percentile | 413.5 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 100th percentile | 2479.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 95th percentile | 2479.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 0 percentile | 413.5 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 50th percentile | 1637.8 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 25th percentile | 640.3 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 100th percentile | 1508.3 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 95th percentile | 1508.3 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 75th percentile | 1094.2 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 5th percentile | 415.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 0 percentile | 415.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 50th percentile | 966.0 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 12 (Year 1) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 5th percentile | 1357.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 50th percentile | 2139.9 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 95th percentile | 2366.3 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 75th percentile | 2335.1 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 0 percentile | 1357.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 25th percentile | 1666.8 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 100th percentile | 2366.3 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 50th percentile | 1756.3 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 75th percentile | 1756.3 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 5th percentile | 1756.3 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 100th percentile | 1756.3 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 25th percentile | 1756.3 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 0 percentile | 1756.3 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 95th percentile | 1756.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 50th percentile | 2414.8 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 25th percentile | 2146.8 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 0 percentile | 1388.7 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 5th percentile | 1388.7 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 95th percentile | 2579.2 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 100th percentile | 2579.2 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 75th percentile | 2480.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 5th percentile | 1531.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 0 percentile | 1340.5 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 25th percentile | 2125.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 50th percentile | 2359.3 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 95th percentile | 2666.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 100th percentile | 2852.3 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 75th percentile | 2563.3 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 25th percentile | 1907.0 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 95th percentile | 2588.2 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 5th percentile | 1659.6 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 0 percentile | 1659.6 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 100th percentile | 2588.2 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 75th percentile | 2293.8 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 50th percentile | 2234.2 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 25th percentile | 1285.5 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 75th percentile | 1700.4 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 50th percentile | 1493.0 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 95th percentile | 1700.4 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 5th percentile | 1285.5 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 100th percentile | 1700.4 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) | 0 percentile | 1285.5 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 24 (Year 2) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 0 percentile | 1350.2 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 75th percentile | 2318.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 5th percentile | 1350.2 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 100th percentile | 2542.1 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 25th percentile | 1432.2 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 95th percentile | 2542.1 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 50th percentile | 2047.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 5th percentile | 2370.2 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 50th percentile | 2474.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 25th percentile | 2370.2 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 75th percentile | 2503.9 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 0 percentile | 2370.2 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 100th percentile | 2503.9 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 95th percentile | 2503.9 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 25th percentile | 1961.0 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 5th percentile | 1301.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 0 percentile | 1301.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 75th percentile | 2443.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 95th percentile | 2624.5 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 50th percentile | 2345.9 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 100th percentile | 2624.5 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 50th percentile | 2152.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 0 percentile | 1526.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 5th percentile | 1526.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 25th percentile | 1721.2 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 75th percentile | 2503.2 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 95th percentile | 2757.6 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 100th percentile | 2757.6 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 25th percentile | 2071.9 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 5th percentile | 1390.0 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 100th percentile | 2732.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 0 percentile | 1390.0 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 95th percentile | 2732.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 50th percentile | 2226.4 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 75th percentile | 2373.1 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 100th percentile | 1924.9 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 75th percentile | 1924.9 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 25th percentile | 694.5 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 5th percentile | 694.5 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 95th percentile | 1924.9 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 0 percentile | 694.5 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) | 50th percentile | 1309.7 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 3 postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 0 percentile | 1364.2 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 100th percentile | 2447.9 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 95th percentile | 2447.9 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 25th percentile | 1409.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 5th percentile | 1364.2 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 50th percentile | 1920.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 75th percentile | 2416.6 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 75th percentile | 2506.3 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 50th percentile | 2361.3 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 5th percentile | 1230.3 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 0 percentile | 1230.3 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 95th percentile | 2549.8 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 25th percentile | 1879.4 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 100th percentile | 2549.8 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 50th percentile | 2171.5 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 0 percentile | 1592.5 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 5th percentile | 1592.5 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 25th percentile | 2025.1 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 75th percentile | 2351.5 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 95th percentile | 2600.8 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 100th percentile | 2600.8 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 25th percentile | 2179.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 75th percentile | 2721.8 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 5th percentile | 2179.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 100th percentile | 2721.8 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 95th percentile | 2721.8 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 0 percentile | 2179.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 50th percentile | 2204.0 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 25th percentile | 2029.8 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 100th percentile | 2040.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 95th percentile | 2040.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 75th percentile | 2040.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 5th percentile | 2029.8 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 0 percentile | 2029.8 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 | 50th percentile | 2035.3 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 36 (Year 3) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 25th percentile | 2324.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 75th percentile | 2324.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 5th percentile | 2324.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 95th percentile | 2324.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 50th percentile | 2324.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 100th percentile | 2324.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 0 percentile | 2324.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 100th percentile | 2478.8 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 0 percentile | 2197.2 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 5th percentile | 2197.2 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 25th percentile | 2197.2 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 50th percentile | 2338.0 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 75th percentile | 2478.8 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) | 95th percentile | 2478.8 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 48 (Year 4) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 100th percentile | 2412.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 50th percentile | 2089.9 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 95th percentile | 2412.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 5th percentile | 1684.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 75th percentile | 2412.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 25th percentile | 1684.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 0 percentile | 1684.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 25th percentile | 2555.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 100th percentile | 2555.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 50th percentile | 2555.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 95th percentile | 2555.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 5th percentile | 2555.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 0 percentile | 2555.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 75th percentile | 2555.7 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 50th percentile | 2334.0 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 0 percentile | 1678.7 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 5th percentile | 1678.7 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 25th percentile | 2304.0 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 75th percentile | 2475.2 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 95th percentile | 2683.7 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 100th percentile | 2683.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 75th percentile | 2375.3 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 100th percentile | 2537.5 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 5th percentile | 1524.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 50th percentile | 2107.5 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 0 percentile | 1524.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 95th percentile | 2537.5 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 25th percentile | 2034.8 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 95th percentile | 2372.3 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 0 percentile | 752.5 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 5th percentile | 752.5 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 25th percentile | 1468.8 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 75th percentile | 1940.5 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 100th percentile | 2372.3 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 50th percentile | 1550.2 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 0 percentile | 716.5 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 50th percentile | 742.0 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 5th percentile | 716.5 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 75th percentile | 767.5 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 95th percentile | 767.5 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 100th percentile | 767.5 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) | 25th percentile | 716.5 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 6 postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 0 percentile | 1361.1 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 75th percentile | 2488.1 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 5th percentile | 1361.1 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 100th percentile | 2488.1 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 25th percentile | 1361.1 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 95th percentile | 2488.1 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 50th percentile | 1457.9 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 5th percentile | 2394.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 50th percentile | 2394.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 25th percentile | 2394.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 75th percentile | 2394.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 0 percentile | 2394.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 100th percentile | 2394.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 95th percentile | 2394.5 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 25th percentile | 2043.0 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 5th percentile | 1418.0 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 0 percentile | 1418.0 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 75th percentile | 2463.9 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 95th percentile | 2547.5 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 50th percentile | 2337.7 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 100th percentile | 2547.5 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 50th percentile | 2257.5 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 0 percentile | 1672.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 5th percentile | 1672.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 25th percentile | 2109.2 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 75th percentile | 2558.3 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 95th percentile | 2662.3 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 100th percentile | 2662.3 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 25th percentile | 1899.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 5th percentile | 1693.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 100th percentile | 2650.8 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 0 percentile | 1693.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 95th percentile | 2650.8 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 50th percentile | 2248.6 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 75th percentile | 2304.3 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 100th percentile | 2059.3 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 75th percentile | 2059.3 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 25th percentile | 1965.6 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 5th percentile | 1965.6 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 95th percentile | 2059.3 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 0 percentile | 1965.6 cells per millimeter squared |
| 3 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 | 50th percentile | 2012.5 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 60 (Year 5) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 5th percentile | 1683.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 75th percentile | 2589.3 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 50th percentile | 2342.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 0 percentile | 1683.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 100th percentile | 2743.8 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 95th percentile | 2743.8 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 25th percentile | 2050.2 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 25th percentile | 2322.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 5th percentile | 2322.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 100th percentile | 2361.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 75th percentile | 2361.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 95th percentile | 2361.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 50th percentile | 2342.0 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 0 percentile | 2322.5 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 5th percentile | 1345.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 95th percentile | 2555.8 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 100th percentile | 2555.8 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 0 percentile | 1345.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 25th percentile | 2080.0 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 50th percentile | 2277.9 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 75th percentile | 2411.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 0 percentile | 1109.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 25th percentile | 1734.2 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 100th percentile | 2958.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 75th percentile | 2417.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 50th percentile | 2035.8 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 95th percentile | 2958.7 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 5th percentile | 1109.0 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 0 percentile | 741.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 75th percentile | 1912.5 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 50th percentile | 1743.6 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 25th percentile | 1372.0 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 100th percentile | 2242.5 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 95th percentile | 2242.5 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) | 5th percentile | 741.7 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 75th percentile | 1660.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 50th percentile | 1660.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 0 percentile | 1660.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 100th percentile | 1660.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 5th percentile | 1660.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 25th percentile | 1660.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 95th percentile | 1660.7 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 0 percentile | 1412.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 95th percentile | 1412.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 50th percentile | 1412.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 75th percentile | 1412.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 100th percentile | 1412.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 25th percentile | 1412.5 cells per millimeter squared |
| Lumen Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 5th percentile | 1412.5 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 50th percentile | 2185.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 0 percentile | 2185.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 5th percentile | 2185.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 25th percentile | 2185.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 75th percentile | 2185.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 95th percentile | 2185.3 cells per millimeter squared |
| Collar Only | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 100th percentile | 2185.3 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 95th percentile | 2460.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 25th percentile | 1959.2 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 75th percentile | 2460.0 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 0 percentile | 1959.2 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 50th percentile | 2209.6 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 5th percentile | 1959.2 cells per millimeter squared |
| 1 Ring | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 100th percentile | 2460.0 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 50th percentile | 1469.9 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 5th percentile | 909.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 100th percentile | 2030.0 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 95th percentile | 2030.0 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 0 percentile | 909.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 25th percentile | 909.7 cells per millimeter squared |
| 2 Rings | Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 75th percentile | 2030.0 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval | Month 96 (Year 8) | 1802.49 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval | Month 108 (Year 9) | 1668.80 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval | Month 120 (Year 10) | 1574.73 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation | Month 96 (Year 8) | 1802.49 cells per millimeter squared | Standard Deviation 520.329 |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation | Month 108 (Year 9) | 1668.80 cells per millimeter squared | Standard Deviation 707.729 |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation | Month 120 (Year 10) | 1574.73 cells per millimeter squared | Standard Deviation 714.996 |
Primary
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 108 (Year 9) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 0 percentile | 458.8 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 5th percentile | 561.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 25th percentile | 805.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 50th percentile | 1867.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 75th percentile | 2222.8 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 95th percentile | 2546.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 100th percentile | 2660.8 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 0 percentile | 413.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 5th percentile | 415.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 25th percentile | 796.6 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 50th percentile | 1640.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 75th percentile | 2165.3 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 95th percentile | 2597.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 100th percentile | 2800.8 cells per millimeter squared |
Primary
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 0 percentile | 909.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 5th percentile | 909.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 25th percentile | 1412.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 50th percentile | 1959.2 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 75th percentile | 2185.3 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 95th percentile | 2460.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 100th percentile | 2460.0 cells per millimeter squared |
Primary
Central Endothelial Hexagonality (CEH) Reported by Mean and Standard Deviation
The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Mean and Standard Deviation | Month 96 (Year 8) | 64.33 percentage of hexagonality | Standard Deviation 5.223 |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Mean and Standard Deviation | Month 108 (Year 9) | 60.96 percentage of hexagonality | Standard Deviation 8.235 |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Mean and Standard Deviation | Month 120 (Year 10) | 62.09 percentage of hexagonality | Standard Deviation 8.589 |
Primary
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9)
The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 108 (Year 9) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) | 0 percentile | 41.0 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) | 5th percentile | 44.3 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) | 25th percentile | 57.8 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) | 50th percentile | 60.8 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) | 75th percentile | 65.7 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) | 95th percentile | 72.5 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) | 100th percentile | 80.7 percentage of hexagonality |
Primary
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8)
The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) | 0 percentile | 57.7 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) | 5th percentile | 57.7 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) | 25th percentile | 59.3 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) | 50th percentile | 66.0 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) | 75th percentile | 68.3 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) | 95th percentile | 71.5 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) | 100th percentile | 71.5 percentage of hexagonality |
Primary
Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10)
The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) | 0 percentile | 43.3 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) | 5th percentile | 44.0 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) | 25th percentile | 57.8 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) | 50th percentile | 63.4 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) | 75th percentile | 68.2 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) | 95th percentile | 75.8 percentage of hexagonality |
| Cataract Surgery + CyPass | Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) | 100th percentile | 78.3 percentage of hexagonality |
Primary
Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval
CCT is a measurement of the thickness of the cornea at its center and is assessed using a procedure called corneal pachymetry. A high CCT (thick cornea) indicates a central cornea thicker than average and may be associated with conditions such as corneal edema, Fuchs' dystrophy, or ocular hypertension. A low CCT (thin cornea) indicates a central cornea thinner than average and may be a risk factor for developing conditions such as glaucoma. A negative change value indicates a decrease in corneal thickness. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cataract Surgery + CyPass | Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval | Change from Baseline at Month 96 (Year 8) | 1.9 microns |
| Cataract Surgery + CyPass | Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval | Change from Baseline at Month 108 (Year 9) | 0.0 microns |
| Cataract Surgery + CyPass | Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval | Change from Baseline at Month 120 (Year 10) | 4.1 microns |
Primary
Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation
CCT is a measurement of the thickness of the cornea at its center and is assessed using a procedure called corneal pachymetry. A high CCT (thick cornea) indicates a central cornea thicker than average and may be associated with conditions such as corneal edema, Fuchs' dystrophy, or ocular hypertension. A low CCT (thin cornea) indicates a central cornea thinner than average and may be a risk factor for developing conditions such as glaucoma. A negative change value indicates a decrease in corneal thickness. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation | Change from Baseline at Month 96 (Year 8) | 1.9 microns | Standard Deviation 22.08 |
| Cataract Surgery + CyPass | Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation | Change from Baseline at Month 108 (Year 9) | 0.0 microns | Standard Deviation 22.84 |
| Cataract Surgery + CyPass | Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation | Change from Baseline at Month 120 (Year 10) | 4.1 microns | Standard Deviation 25.09 |
Primary
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval | Change from Baseline at Month 96 (Year 8) | -612.31 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval | Change from Baseline at Month 108 (Year 9) | -762.63 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval | Change from Baseline at Month 120 (Year 10) | -819.62 cells per millimeter squared |
Primary
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation | Change from Baseline at Month 96 (Year 8) | -612.31 cells per millimeter squared | Standard Deviation 704.719 |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation | Change from Baseline at Month 108 (Year 9) | -762.63 cells per millimeter squared | Standard Deviation 706.732 |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation | Change from Baseline at Month 120 (Year 10) | -819.62 cells per millimeter squared | Standard Deviation 696.501 |
Primary
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 108 (Year 9) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 0 percentile | -2028.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 5th percentile | -1893.8 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 25th percentile | -1450.1 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 50th percentile | -590.3 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 75th percentile | -198.3 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 95th percentile | 308.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 100th percentile | 807.6 cells per millimeter squared |
Primary
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 0 percentile | -1937.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 5th percentile | -1873.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 25th percentile | -1416.4 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 50th percentile | -907.6 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 75th percentile | -232.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 95th percentile | 253.8 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 100th percentile | 752.1 cells per millimeter squared |
Primary
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 0 percentile | -1802.6 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 5th percentile | -1802.6 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 25th percentile | -1246.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 50th percentile | -444.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 75th percentile | 60.2 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 95th percentile | 161.8 cells per millimeter squared |
| Cataract Surgery + CyPass | Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 100th percentile | 161.8 cells per millimeter squared |
Primary
Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported by Mean and Standard Deviation
Visual field mean deviation is a measure used in visual field testing to assess the overall sensitivity of a patient's vision compared to a standardized norm. The Humphrey automated perimeter with the 24-2 Swedish Interactive Thresholding Algorithm (SITA) standard testing method was used. Deviations were recorded in decibels. Normal deviation values are typically within 0 to -2 decibels (dB). A more negative number indicates decreased sensitivity and worsening of the overall visual field. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Screening (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported by Mean and Standard Deviation | Change from Screening Visit at Month 96 (Year 8) | 2.379 decibel | Standard Deviation 3.7404 |
| Cataract Surgery + CyPass | Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported by Mean and Standard Deviation | Change from Screening Visit at Month 108 (Year 9) | -1.176 decibel | Standard Deviation 6.1884 |
| Cataract Surgery + CyPass | Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported by Mean and Standard Deviation | Change from Screening Visit at Month 120 (Year 10) | -2.321 decibel | Standard Deviation 4.6707 |
Primary
Number of Corneal Adverse Events Caused by CyPass MicroStent
A corneal adverse event is an undesirable occurrence related to the cornea, such as inflammation, edema, epithelial defects, or other complications. The number of corneal adverse events caused by the CyPass Micro-Stent was assessed from patient reporting, clinical observation and documentation during patients' follow-up visits. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8) to Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cataract Surgery + CyPass | Number of Corneal Adverse Events Caused by CyPass MicroStent | 0 events |
Primary
Number of Corneal Sequelae Events Associated With Endothelial Cell Loss (ECL)
Corneal sequelae are occurrences of complications related to ECL in the cornea and may include corneal edema, decreased visual acuity, corneal decompensation, bullous keratopathy, etc. Corneal sequelae were quantified by counting the instances where patients experienced complications attributable to endothelial cell loss. A higher number of corneal sequelae events may indicate rapid disease progression or inadequate management of conditions leading to endothelial cell loss. A lower number of corneal sequelae events may indicate a favorable response to treatment and successful disease treatment or treatment stabilization. This analysis was performed using data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cataract Surgery + CyPass | Number of Corneal Sequelae Events Associated With Endothelial Cell Loss (ECL) | 0 corneal sequelae |
Primary
Number of Events of Best Corrected Visual Acuity (BCVA) Loss of 10 Letters or More
Visual acuity was measured with correction in place using letter charts. BCVA \[synonymous with Best Corrected Distance Visual Acuity (BCDVA)\] at each visit was compared to the participant's best achieved BCVA recorded throughout the 10-year period after CyPass implantation. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8) to Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cataract Surgery + CyPass | Number of Events of Best Corrected Visual Acuity (BCVA) Loss of 10 Letters or More | 21 events |
Primary
Number of Secondary Surgical Intervention (SSI) Events to Modify the Device Position (eg, Repositioning, Trimming, Explantation)
SSI events are additional surgical procedures performed after the initial placement of the CyPass micro-stent device to adjust its position or address issues related to its placement. SSI were noted through adverse event reporting, clinical evaluation, comprehensive documentation of outcome assessment and data analysis. A higher number of SSI events may indicate challenges or complications related to the initial placement of the CyPass device, technical difficulties during the initial surgery, device-related issues, or patient-specific factors contributing to the need for additional interventions. A lower number of SSI events may suggest that the initial device placement was successful and well-tolerated, with fewer complications or the need for adjustments. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8) to Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cataract Surgery + CyPass | Number of Secondary Surgical Intervention (SSI) Events to Modify the Device Position (eg, Repositioning, Trimming, Explantation) | 0 secondary surgical interventions |
Primary
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS, COMPASS XT, and COMPASS XXT studies. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 3 | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 6 | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 12 (Year 1) | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 24 (Year 2) | 1.9 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 36 (Year 3) | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 48 (Year 4) | 9.7 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 60 (Year 5) | 6.7 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 96 (Year 8) | 14.3 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 108 (Year 9) | 26.2 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 120 (Year 10) | 31.6 percentage of eyes |
Primary
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS, COMPASS XT, and COMPASS XXT studies. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 3 | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 6 | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 12 (Year 1) | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 24 (Year 2) | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 36 (Year 3) | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 48 (Year 4) | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 60 (Year 5) | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 96 (Year 8) | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 108 (Year 9) | 2.4 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 120 (Year 10) | 7.9 percentage of eyes |
Primary
Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS, COMPASS XT, and COMPASS XXT studies. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline | >30% Loss from Baseline at Month 3 | 9.6 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline | >30% Loss from Baseline at Month 6 | 9.4 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline | >30% Loss from Baseline at Month 12 (Year 1) | 13.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline | >30% Loss from Baseline at Month 24 (Year 2) | 9.4 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline | >30% Loss from Baseline at Month 36 (Year 3) | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline | >30% Loss from Baseline at Month 48 (Year 4) | 19.4 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline | >30% Loss from Baseline at Month 60 (Year 5) | 26.7 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline | >30% Loss from Baseline at Month 96 (Year 8) | 28.6 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline | >30% Loss from Baseline at Month 108 (Year 9) | 40.5 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline | >30% Loss from Baseline at Month 120 (Year 10) | 52.6 percentage of eyes |
Primary
Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared
Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 96 (Year 8) | 14.3 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 108 (Year 9) | 23.8 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared | Month 120 (Year 20) | 30.0 percentage of eyes |
Primary
Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared
Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 96 (Year 8) | 14.3 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 108 (Year 9) | 4.8 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared | Month 120 (Year 20) | 6.7 percentage of eyes |
Primary
Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB)
Visual field mean deviation is a measure used in visual field testing to assess the overall sensitivity of a patient's vision compared to a standardized norm. The Humphrey automated perimeter with the 24-2 SITA standard testing method was used. Deviations were recorded in decibels. Normal deviation values are typically within 0 to -2 decibels (dB). A more negative number indicates decreased sensitivity and worsening of the overall visual field. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Screening (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) | Change from Screening Visit at Month 108 (Year 9) | 9.8 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) | Change from Screening Visit at Month 96 (Year 8) | 42.9 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) | Change from Screening Visit at Month 120 (Year 10) | 10.9 percentage of eyes |
| Lumen Only | Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) | Change from Screening Visit at Month 108 (Year 9) | 51.2 percentage of eyes |
| Lumen Only | Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) | Change from Screening Visit at Month 96 (Year 8) | 51.7 percentage of eyes |
| Lumen Only | Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) | Change from Screening Visit at Month 120 (Year 10) | 45.7 percentage of eyes |
| Collar Only | Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) | Change from Screening Visit at Month 96 (Year 8) | 0.0 percentage of eyes |
| Collar Only | Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) | Change from Screening Visit at Month 120 (Year 10) | 43.5 percentage of eyes |
| Collar Only | Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) | Change from Screening Visit at Month 108 (Year 9) | 39.0 percentage of eyes |
Primary
Percentage of Eyes With CyPass Micro-Stent Movement and/or Malposition
CyPass micro-stent movement and/or malposition refers to issues related to the displacement or improper positioning of the CyPass Micro-Stent in the eye's drainage angle. The investigator qualitatively and subjectively assessed the position of the device by counting the visible number of rings of the device during a gonioscopic exam, which used a specialized lens to visually assess the position and stability of the CyPass device. Movement and/or malposition may suggest a greater risk of complications or inadequate treatment of glaucoma. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8) to Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cataract Surgery + CyPass | Percentage of Eyes With CyPass Micro-Stent Movement and/or Malposition | 7.4 percentage of eyes |
Primary
Percentage of Eyes With Ocular Adverse Events
An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). This analysis was performed using data from visits in the COMPASS XXT study and includes ocular events other than sight-threatening adverse events. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8) to Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Dermatitis | 1.9 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Visual Acuity Reduced | 38.9 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Visual Field Defect | 37.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Corneal Endothelial Cell Loss | 11.1 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Post Procedural Complication | 9.3 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Device Placement Issue | 5.6 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Hypotony Of Eye | 3.7 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Intraocular Pressure Increased | 3.7 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Optic Nerve Cup/Disc Ratio | 3.7 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Trabeculectomy | 3.7 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Cystoid Macular Oedema | 1.9 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Device Dislocation | 1.9 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Ocular Adverse Events | Trabeculoplasty | 1.9 percentage of eyes |
Primary
Percentage of Eyes With Sight-threatening Adverse Events (AEs)
An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). This analysis was performed using data from visits in the COMPASS XXT study and includes sight-threatening adverse events as specified in the protocol. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8) to Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percentage of Eyes With Sight-threatening Adverse Events (AEs) | Persistent BCDVA loss of 3 lines or more compared to best BCDVA collected at any time during study | 18.5 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Sight-threatening Adverse Events (AEs) | Endophthalmitis | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Sight-threatening Adverse Events (AEs) | Corneal decompensation | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Sight-threatening Adverse Events (AEs) | Retinal detachment | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Sight-threatening Adverse Events (AEs) | Severe choroidal hemorrhage or detachment | 0.0 percentage of eyes |
| Cataract Surgery + CyPass | Percentage of Eyes With Sight-threatening Adverse Events (AEs) | Aqueous misdirection | 0.0 percentage of eyes |
Primary
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval | Change from Baseline at Month 96 (Year 8) | -22.77 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval | Change from Baseline at Month 108 (Year 9) | -30.60 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval | Change from Baseline at Month 120 (Year 10) | -33.57 percent change |
Primary
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation | Change from Baseline at Month 96 (Year 8) | -22.77 percent change | Standard Deviation 26.468 |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation | Change from Baseline at Month 108 (Year 9) | -30.60 percent change | Standard Deviation 31.07 |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation | Change from Baseline at Month 120 (Year 10) | -33.57 percent change | Standard Deviation 31.673 |
Primary
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 108 (Year 9) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 0 percentile | -79.9 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 5th percentile | -74.8 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 25th percentile | -65.5 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 50th percentile | -24.9 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 75th percentile | -8.1 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 95th percentile | 18.0 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) | 100th percentile | 50.1 percent change |
Primary
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 0 percentile | -81.9 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 5th percentile | -80.1 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 25th percentile | -61.9 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 50th percentile | -35.8 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 75th percentile | -8.6 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 95th percentile | 16.7 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) | 100th percentile | 46.7 percent change |
Primary
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8)
Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 0 percentile | -66.5 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 5th percentile | -66.5 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 25th percentile | -46.9 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 50th percentile | -16.9 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 75th percentile | 3.8 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 95th percentile | 7.0 percent change |
| Cataract Surgery + CyPass | Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) | 100th percentile | 7.0 percent change |
Primary
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation
Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 96 (Year 8) | 2132.70 cells per millimeter squared | — |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 120 (Year 10) | 2177.90 cells per millimeter squared | Standard Deviation 988.439 |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 108 (Year 9) | 2062.49 cells per millimeter squared | Standard Deviation 728.658 |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 108 (Year 9) | 1828.05 cells per millimeter squared | Standard Deviation 399.061 |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 96 (Year 8) | 1390.60 cells per millimeter squared | — |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 120 (Year 10) | 1955.98 cells per millimeter squared | Standard Deviation 348.144 |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 108 (Year 9) | 2087.86 cells per millimeter squared | Standard Deviation 599.144 |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 96 (Year 8) | 2227.00 cells per millimeter squared | — |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 120 (Year 10) | 1663.57 cells per millimeter squared | Standard Deviation 730.987 |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 96 (Year 8) | 2103.20 cells per millimeter squared | Standard Deviation 152.028 |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 120 (Year 10) | 1683.19 cells per millimeter squared | Standard Deviation 909.922 |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 108 (Year 9) | 1752.28 cells per millimeter squared | Standard Deviation 835.401 |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 108 (Year 9) | 915.63 cells per millimeter squared | Standard Deviation 585.915 |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 96 (Year 8) | 1477.45 cells per millimeter squared | Standard Deviation 1396.889 |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation | Month 120 (Year 10) | 976.46 cells per millimeter squared | Standard Deviation 550.677 |
Primary
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9)
Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 108 (Year 9) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 0 percentile | 516.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 100th percentile | 2814.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 95th percentile | 2814.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 25th percentile | 1848.4 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 5th percentile | 516.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 50th percentile | 2272.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 75th percentile | 2515.5 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 75th percentile | 2080.3 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 50th percentile | 1796.7 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 5th percentile | 1373.0 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 0 percentile | 1373.0 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 95th percentile | 2345.8 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 25th percentile | 1575.9 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 100th percentile | 2345.8 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 50th percentile | 2262.3 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 0 percentile | 569.0 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 5th percentile | 569.0 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 25th percentile | 2106.0 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 75th percentile | 2331.2 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 95th percentile | 2784.7 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 100th percentile | 2784.7 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 25th percentile | 803.8 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 75th percentile | 2483.8 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 5th percentile | 449.5 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 100th percentile | 2772.0 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 95th percentile | 2772.0 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 0 percentile | 449.5 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 50th percentile | 2037.3 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 25th percentile | 514.8 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 100th percentile | 1949.5 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 95th percentile | 1949.5 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 75th percentile | 1283.2 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 5th percentile | 479.2 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 0 percentile | 479.2 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) | 50th percentile | 633.6 cells per millimeter squared |
Primary
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10)
Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 0 percentile | 526.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 100th percentile | 3183.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 95th percentile | 3183.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 25th percentile | 2262.8 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 5th percentile | 526.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 50th percentile | 2408.8 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 75th percentile | 2507.7 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 75th percentile | 2157.6 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 50th percentile | 2042.5 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 5th percentile | 1512.7 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 0 percentile | 1512.7 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 95th percentile | 2371.3 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 25th percentile | 1695.8 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 100th percentile | 2371.3 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 50th percentile | 1709.8 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 0 percentile | 647.7 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 5th percentile | 647.7 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 25th percentile | 922.5 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 75th percentile | 2250.2 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 95th percentile | 2597.0 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 100th percentile | 2597.0 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 25th percentile | 683.0 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 75th percentile | 2412.6 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 5th percentile | 477.0 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 100th percentile | 2637.3 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 95th percentile | 2637.3 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 0 percentile | 477.0 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 50th percentile | 2080.0 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 25th percentile | 643.2 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 100th percentile | 1759.5 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 95th percentile | 1759.5 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 75th percentile | 1269.8 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 5th percentile | 353.3 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 0 percentile | 353.3 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) | 50th percentile | 856.5 cells per millimeter squared |
Primary
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8)
Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 0 percentile | 2132.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 100th percentile | 2132.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 95th percentile | 2132.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 25th percentile | 2132.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 5th percentile | 2132.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 50th percentile | 2132.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 75th percentile | 2132.7 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 75th percentile | 1390.6 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 50th percentile | 1390.6 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 5th percentile | 1390.6 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 0 percentile | 1390.6 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 95th percentile | 1390.6 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 25th percentile | 1390.6 cells per millimeter squared |
| Lumen Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 100th percentile | 1390.6 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 50th percentile | 2227.0 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 0 percentile | 2227.0 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 5th percentile | 2227.0 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 25th percentile | 2227.0 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 75th percentile | 2227.0 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 95th percentile | 2227.0 cells per millimeter squared |
| Collar Only | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 100th percentile | 2227.0 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 25th percentile | 1995.7 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 75th percentile | 2210.7 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 5th percentile | 1995.7 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 100th percentile | 2210.7 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 95th percentile | 2210.7 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 0 percentile | 1995.7 cells per millimeter squared |
| 1 Ring | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 50th percentile | 2103.2 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 25th percentile | 489.7 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 100th percentile | 2465.2 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 95th percentile | 2465.2 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 75th percentile | 2465.2 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 5th percentile | 489.7 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 0 percentile | 489.7 cells per millimeter squared |
| 2 Rings | Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) | 50th percentile | 1477.5 cells per millimeter squared |
Primary
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval
Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval | Month 96 (Year 8) | 1844.51 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval | Month 108 (Year 9) | 1739.44 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval | Month 120 (Year 10) | 1688.74 cells per millimeter squared |
Primary
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation
Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation | Month 96 (Year 8) | 1844.51 cells per millimeter squared | Standard Deviation 684.727 |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation | Month 108 (Year 9) | 1739.44 cells per millimeter squared | Standard Deviation 779.814 |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation | Month 120 (Year 10) | 1688.74 cells per millimeter squared | Standard Deviation 803.605 |
Primary
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9)
Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 108 (Year 9) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 0 percentile | 449.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 5th percentile | 510.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 25th percentile | 1024.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 50th percentile | 2020.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 75th percentile | 2341.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 95th percentile | 2772.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) | 100th percentile | 2814.0 cells per millimeter squared |
Primary
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10)
Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 120 (Year 10) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 0 percentile | 353.3 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 5th percentile | 477.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 25th percentile | 856.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 50th percentile | 1865.4 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 75th percentile | 2345.5 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 95th percentile | 2637.3 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) | 100th percentile | 3183.7 cells per millimeter squared |
Primary
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8)
Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.
Time frame: Month 96 (Year 8) postoperative
Population: All enrolled with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 0 percentile | 489.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 5th percentile | 489.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 25th percentile | 1390.6 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 50th percentile | 2132.7 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 75th percentile | 2227.0 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 95th percentile | 2465.2 cells per millimeter squared |
| Cataract Surgery + CyPass | Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) | 100th percentile | 2465.2 cells per millimeter squared |