Primary Open Angle Glaucoma (POAG)
Conditions
Brief summary
The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in subjects who completed Study Protocol TMI-09-01, COMPASS Trial.
Detailed description
The COMPASS Trial (TMI-09-01) 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 study, 505 subjects were randomized to either the CyPass group, who underwent cataract surgery and received the CyPass Micro-Stent, or the Control group, who underwent cataract surgery alone. All subjects randomized were to be followed for 2 years postoperatively. Four hundred eighty (480) subjects completed this study. The COMPASS-XT (TMI-09-01-E) Trial is designed to collect safety data beyond 24 months postoperatively for subjects who completed the COMPASS Trial. In COMPASS-XT, clinical data will be collected at 36 months, 48 months, and 60 months postoperatively for a total of 5 year follow-up across the 2 studies.
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
Transcend Medical, Inc.
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Completed the COMPASS Trial 2. Understands study requirements and is willing to follow study instructions and return for study visits
Exclusion criteria
1. Systemic disease that would put subject health at risk and/or prevent completion of required study visits. 2. Early termination from the COMPASS Trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group | Up to Month 60 postoperative | Sight-threatening adverse events occurring in the study eye included, but were not limited to: BCVA loss of ≥ 3 lines, endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment and aqueous misdirection. The number of events at the end of Year 5 was divided by the number of eyes at risk at the beginning of Year 1 for a 5-year annualized rate. The 5-year annualized rate is reported as a percentage, with the last annual non-censored rate divided by 5. Inferential testing was not planned for this endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Reported at Least One Protocol-specified Ocular Adverse Event in the Study Eye | Up to Month 60 postoperative | Ocular adverse events in the study eye could include, but were not limited to, BCVA loss of 2 lines (10 letters) or more on the ETDRS chart in comparison with the best BCVA reported in Study Protocol TMI-09-01, endophthalmitis, corneal edema, and corneal decompensation. Inferential testing was not planned for this endpoint. |
| Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema | Month 36, 48, 60 postoperative | Corneal Edema (swelling of the cornea) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None (transparent and clear or less than mild), Mild (dull glassy appearance), Moderate (Dull glassy appearance of epithelium with large number of vacuoles), and Severe (epithelial bullae and/or stromal edema, localized or diffuse, with or without stromal striae). Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Month 36, 48, 60 postoperative | Corneal Staining (appearance of tissue disruption and other pathophysiological changes) and erosion (abrasion) were assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None (no fluorescein staining of epithelium, OR less than mild), Mild (slight fluorescein staining confined to a small focus), Moderate (regionally dense fluorescein staining (1 mm or greater in diameter) with underlying structure moderately visible), and Severe (marked fluorescein staining or epithelial loss). Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells | Month 36, 48, 60 postoperative | Inflammatory anterior chamber cells (cells in the front portion of the eye) were assessed by the investigator during slit-lamp examination and reported in one of 6 categories according to cells per 1x1 mm slit: 0-\<1 cell, 1-5 cells, 6-15 cells, 16-25 cells, and 26-50 cells, and \>50 cells. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare | Month 36, 48, 60 postoperative | Anterior Chamber Flare (protein escaping from dilated vessels) was assessed by the investigator during slit-lamp examination and rated on a 5-point scale: None, Faint, Moderate (iris and lens details clear), Marked (iris and lens details hazy), and Intense (fibrin or plastic aqueous). The presence of flare is a sign of intraocular inflammation. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | Month 36, 48, 60 postoperative | Iris Atrophy/Erosion (deterioration) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking | Month 36, 48, 60 postoperative | Iris Peaking (one part of the iris pulled to a peak resulting in an irregular pupil) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis | Month 36, 48, 60 postoperative | Iris Rubeosis (abnormal blood vessels (formed by neovascularization) found on the surface of the iris) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Month 36, 48, 60 postoperative | PCO (cloudy layer of scar tissue behind the lens implant) Severity was assessed by the investigator during slit-lamp examination and rated on a 6-point scale: None, Minimal, Mild, Moderate, Severe, and Unspecified. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Baseline, Month 12, 24, 36, 48, 60 postoperative | Best corrected (with spectacles or other visual corrective devices) VA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 1 or 4 meters and determined by total number of letters read correctly. 20/20 Snellen is considered 'normal' vision. A larger denominator indicates a lower visual acuity. Baseline, Month 12, and Month 24 data derived from previous COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Month 36, 48, 60 postoperative | The dilated fundus examination was performed by the investigator to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. Clinically significant findings are reported categorically. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Change From Month 24 in Visual Field Mean Deviation | Month 24, 36, 48, 60 postoperative | Visual field (how much one can see to each side while focusing the eyes on a central point (peripheral vision)) deviations were obtained with a Humphrey automated perimeter using the 24-2 SITA standard testing method. Normal deviation values are typically within 0 to -2 decibels (dB) and become more negative as the overall field worsens. Month 24 data derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Change From Month 24 in Central Corneal Thickness | Month 24, 36, 48, 60 postoperative | Central corneal thickness was evaluated by Pachymetry and measured in micrometers (μm). A negative number indicates a decrease in corneal thickness (unfavorable). Month 24 data derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Central Corneal Endothelial Cell Density (ECD) by Visit | Baseline, Month 3, 6, 12, 24, 36, 48, 60 postoperative | The endothelium maintains corneal hydration and reduced cell density can disrupt vision. Central endothelial cell counts were assessed using non-contact specular microscopy. Specular images were taken of the corneal endothelium and submitted to a reading center in order to standardize readings across all sites and optimize reading reliability. Baseline through Month 24 data were derived from COMPASS trial. A higher cell density indicates improvement. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Number of Subjects With CyPass Device Malposition, Dislodgement or Movement | Up to 60 months postoperatively | Device position was a qualitative and subjective assessment by the investigator and evaluated based on visible number of rings of the device under the gonioscopic exam. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. This outcome measure was prespecified for Cataract Surgery + CyPass arm only. |
| Mean Reduction From Baseline in Intraocular Pressure (IOP) | Baseline, Month 36, 48, 60 postoperative | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A higher reduction from baseline (ie, a greater postitive number) indicates greater improvement. Baseline was derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications | Baseline, Month 36, 48, 60 postoperative | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg | Month 36, 48, 60 postoperative | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
| Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only | Month 36, 48, 60 postoperative | For subjects in the CyPass group, gonioscopic examination was performed to assess the position of the CyPass Micro-Stent in the angle and with respect to the iris and the corneal endothelium. A visible CyPass Micro-Stent indicated a lack of adhesions (favorable). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 23 study sites located in the US.
Pre-assignment details
This reporting group includes all enrolled subjects (282).
Participants by arm
| Arm | Count |
|---|---|
| Cataract Surgery + CyPass CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial) | 215 |
| Cataract Surgery Only Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation | 67 |
| Total | 282 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Reason not specified | 3 | 2 |
| Overall Study | Withdrawal by Subject | 8 | 9 |
Baseline characteristics
| Characteristic | Cataract Surgery + CyPass | Cataract Surgery Only | Total |
|---|---|---|---|
| Age, Continuous | 69.4 years STANDARD_DEVIATION 7.9 | 70.8 years STANDARD_DEVIATION 7.5 | 69.7 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 4 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 204 Participants | 63 Participants | 267 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 21 Participants | 7 Participants | 28 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 191 Participants | 58 Participants | 249 Participants |
| Sex: Female, Male Female | 116 Participants | 37 Participants | 153 Participants |
| Sex: Female, Male Male | 99 Participants | 30 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 215 | 0 / 67 | 2 / 215 | 1 / 67 |
| other Total, other adverse events | 43 / 215 | 10 / 67 | 0 / 215 | 0 / 67 |
| serious Total, serious adverse events | 2 / 215 | 1 / 67 | 17 / 215 | 5 / 67 |
Outcome results
Primary
5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group
Sight-threatening adverse events occurring in the study eye included, but were not limited to: BCVA loss of ≥ 3 lines, endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment and aqueous misdirection. The number of events at the end of Year 5 was divided by the number of eyes at risk at the beginning of Year 1 for a 5-year annualized rate. The 5-year annualized rate is reported as a percentage, with the last annual non-censored rate divided by 5. Inferential testing was not planned for this endpoint.
Time frame: Up to Month 60 postoperative
Population: All enrolled subjects with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cataract Surgery + CyPass | 5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group | 0.19 rate (percentage) of adverse events |
| Cataract Surgery Only | 5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group | 0.30 rate (percentage) of adverse events |
Secondary
Central Corneal Endothelial Cell Density (ECD) by Visit
The endothelium maintains corneal hydration and reduced cell density can disrupt vision. Central endothelial cell counts were assessed using non-contact specular microscopy. Specular images were taken of the corneal endothelium and submitted to a reading center in order to standardize readings across all sites and optimize reading reliability. Baseline through Month 24 data were derived from COMPASS trial. A higher cell density indicates improvement. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Baseline, Month 3, 6, 12, 24, 36, 48, 60 postoperative
Population: All subject eyes for which data was available at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Central Corneal Endothelial Cell Density (ECD) by Visit | Baseline | 2432.6 cells/mm2 | Standard Deviation 369.7 |
| Cataract Surgery + CyPass | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 3 | 2199.2 cells/mm2 | Standard Deviation 445.5 |
| Cataract Surgery + CyPass | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 6 | 2195.9 cells/mm2 | Standard Deviation 431.4 |
| Cataract Surgery + CyPass | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 12 | 2194.3 cells/mm2 | Standard Deviation 448.6 |
| Cataract Surgery + CyPass | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 24 | 2142.6 cells/mm2 | Standard Deviation 423.3 |
| Cataract Surgery + CyPass | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 36 | 2148.1 cells/mm2 | Standard Deviation 382.7 |
| Cataract Surgery + CyPass | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 48 | 1992.9 cells/mm2 | Standard Deviation 460.8 |
| Cataract Surgery + CyPass | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 60 | 1931.2 cells/mm2 | Standard Deviation 517.5 |
| Cataract Surgery Only | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 60 | 2189.1 cells/mm2 | Standard Deviation 375.6 |
| Cataract Surgery Only | Central Corneal Endothelial Cell Density (ECD) by Visit | Baseline | 2434.5 cells/mm2 | Standard Deviation 319.6 |
| Cataract Surgery Only | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 24 | 2218.9 cells/mm2 | Standard Deviation 376 |
| Cataract Surgery Only | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 3 | 2227.0 cells/mm2 | Standard Deviation 422.4 |
| Cataract Surgery Only | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 48 | 2303.2 cells/mm2 | Standard Deviation 334.5 |
| Cataract Surgery Only | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 6 | 2209.2 cells/mm2 | Standard Deviation 412.2 |
| Cataract Surgery Only | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 36 | 2258.0 cells/mm2 | Standard Deviation 338.9 |
| Cataract Surgery Only | Central Corneal Endothelial Cell Density (ECD) by Visit | Month 12 | 2210.9 cells/mm2 | Standard Deviation 383.8 |
Secondary
Change From Month 24 in Central Corneal Thickness
Central corneal thickness was evaluated by Pachymetry and measured in micrometers (μm). A negative number indicates a decrease in corneal thickness (unfavorable). Month 24 data derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 24, 36, 48, 60 postoperative
Population: Subject eyes for which data was available at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Change From Month 24 in Central Corneal Thickness | Change at Month 48 | -1.4 micrometers | Standard Deviation 16.2 |
| Cataract Surgery + CyPass | Change From Month 24 in Central Corneal Thickness | Month 24 | 553.8 micrometers | Standard Deviation 35.1 |
| Cataract Surgery + CyPass | Change From Month 24 in Central Corneal Thickness | Change at Month 60 | -1.7 micrometers | Standard Deviation 18.8 |
| Cataract Surgery + CyPass | Change From Month 24 in Central Corneal Thickness | Change at Month 36 | 4.7 micrometers | Standard Deviation 16.3 |
| Cataract Surgery Only | Change From Month 24 in Central Corneal Thickness | Change at Month 60 | -4.3 micrometers | Standard Deviation 14.1 |
| Cataract Surgery Only | Change From Month 24 in Central Corneal Thickness | Month 24 | 558.1 micrometers | Standard Deviation 31.9 |
| Cataract Surgery Only | Change From Month 24 in Central Corneal Thickness | Change at Month 48 | -3.8 micrometers | Standard Deviation 13.3 |
| Cataract Surgery Only | Change From Month 24 in Central Corneal Thickness | Change at Month 36 | -0.6 micrometers | Standard Deviation 10.6 |
Secondary
Change From Month 24 in Visual Field Mean Deviation
Visual field (how much one can see to each side while focusing the eyes on a central point (peripheral vision)) deviations were obtained with a Humphrey automated perimeter using the 24-2 SITA standard testing method. Normal deviation values are typically within 0 to -2 decibels (dB) and become more negative as the overall field worsens. Month 24 data derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 24, 36, 48, 60 postoperative
Population: All subject eyes for which data was available at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Change From Month 24 in Visual Field Mean Deviation | Month 24 | -2.8 dB | Standard Deviation 3.3 |
| Cataract Surgery + CyPass | Change From Month 24 in Visual Field Mean Deviation | Change at Month 36 | -0.0 dB | Standard Deviation 2.6 |
| Cataract Surgery + CyPass | Change From Month 24 in Visual Field Mean Deviation | Change at Month 48 | -0.7 dB | Standard Deviation 2.3 |
| Cataract Surgery + CyPass | Change From Month 24 in Visual Field Mean Deviation | Change at Month 60 | -0.8 dB | Standard Deviation 3.6 |
| Cataract Surgery Only | Change From Month 24 in Visual Field Mean Deviation | Change at Month 60 | -0.6 dB | Standard Deviation 2.2 |
| Cataract Surgery Only | Change From Month 24 in Visual Field Mean Deviation | Month 24 | -3.2 dB | Standard Deviation 4 |
| Cataract Surgery Only | Change From Month 24 in Visual Field Mean Deviation | Change at Month 48 | -0.2 dB | Standard Deviation 2.3 |
| Cataract Surgery Only | Change From Month 24 in Visual Field Mean Deviation | Change at Month 36 | -0.2 dB | Standard Deviation 1.5 |
Secondary
Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only
For subjects in the CyPass group, gonioscopic examination was performed to assess the position of the CyPass Micro-Stent in the angle and with respect to the iris and the corneal endothelium. A visible CyPass Micro-Stent indicated a lack of adhesions (favorable). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 36, 48, 60 postoperative
Population: Number of eyes with available data and CyPass not explanted before visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only | Month 36 | 47 eyes |
| Cataract Surgery + CyPass | Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only | Month 48 | 133 eyes |
| Cataract Surgery + CyPass | Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only | Month 60 | 162 eyes |
| Cataract Surgery Only | Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only | Month 36 | 1 eyes |
| Cataract Surgery Only | Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only | Month 48 | 7 eyes |
| Cataract Surgery Only | Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only | Month 60 | 15 eyes |
Secondary
Mean Reduction From Baseline in Intraocular Pressure (IOP)
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A higher reduction from baseline (ie, a greater postitive number) indicates greater improvement. Baseline was derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Baseline, Month 36, 48, 60 postoperative
Population: All subject eyes for which data was available at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cataract Surgery + CyPass | Mean Reduction From Baseline in Intraocular Pressure (IOP) | Baseline | 24.5 mmHg | Standard Deviation 2.9 |
| Cataract Surgery + CyPass | Mean Reduction From Baseline in Intraocular Pressure (IOP) | Reduction at Month 36 | 8.9 mmHg | Standard Deviation 4.2 |
| Cataract Surgery + CyPass | Mean Reduction From Baseline in Intraocular Pressure (IOP) | Reduction at Month 48 | 8.4 mmHg | Standard Deviation 4.5 |
| Cataract Surgery + CyPass | Mean Reduction From Baseline in Intraocular Pressure (IOP) | Reduction at Month 60 | 8.4 mmHg | Standard Deviation 4 |
| Cataract Surgery Only | Mean Reduction From Baseline in Intraocular Pressure (IOP) | Reduction at Month 60 | 8.0 mmHg | Standard Deviation 4.4 |
| Cataract Surgery Only | Mean Reduction From Baseline in Intraocular Pressure (IOP) | Baseline | 24.8 mmHg | Standard Deviation 3.1 |
| Cataract Surgery Only | Mean Reduction From Baseline in Intraocular Pressure (IOP) | Reduction at Month 48 | 7.9 mmHg | Standard Deviation 4.1 |
| Cataract Surgery Only | Mean Reduction From Baseline in Intraocular Pressure (IOP) | Reduction at Month 36 | 8.2 mmHg | Standard Deviation 4.6 |
Secondary
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
Best corrected (with spectacles or other visual corrective devices) VA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 1 or 4 meters and determined by total number of letters read correctly. 20/20 Snellen is considered 'normal' vision. A larger denominator indicates a lower visual acuity. Baseline, Month 12, and Month 24 data derived from previous COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Baseline, Month 12, 24, 36, 48, 60 postoperative
Population: All enrolled subjects with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/20 or Better @ Month 36 | 72 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/40 or Better @ Month 12 | 213 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/25 or Better @ Month 36 | 105 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/25 or Better @ Baseline | 55 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/32 or Better @ Month 36 | 121 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Worse than 20/40 @ Month 12 | 1 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/40 or Better @ Month 36 | 132 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/20 or Better @ Month 12 | 145 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Worse than 20/40 @ Month 36 | 2 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/20 or Better @ Month 24 | 150 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/20 or Better @ Month 48 | 102 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/40 or Better @ Baseline | 171 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/25 or Better @ Month 48 | 143 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/25 or Better @ Month 24 | 198 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/32 or Better @ Month 48 | 165 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/25 or Better @ Month 12 | 192 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/40 or Better @ Month 48 | 172 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/32 or Better @ Month 24 | 213 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Worse than 20/40 @ Month 48 | 2 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/32 or Better @ Baseline | 106 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/20 or Better @ Month 60 | 126 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/40 or Better @ Month 24 | 215 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/25 or Better @ Month 60 | 165 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/32 or Better @ Month 12 | 212 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/32 or Better @ Month 60 | 185 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Worse than 20/40 @ Month 24 | 0 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/40 or Better @ Month 60 | 192 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Worse than 20/40 @ Baseline | 44 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Worse than 20/40 @ Month 60 | 4 subjects |
| Cataract Surgery + CyPass | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/20 or Better @ Baseline | 14 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Worse than 20/40 @ Month 60 | 0 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/20 or Better @ Baseline | 2 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/25 or Better @ Baseline | 17 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/32 or Better @ Baseline | 34 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/40 or Better @ Baseline | 52 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Worse than 20/40 @ Baseline | 15 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/20 or Better @ Month 12 | 49 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/25 or Better @ Month 12 | 59 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/32 or Better @ Month 12 | 64 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/40 or Better @ Month 12 | 66 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Worse than 20/40 @ Month 12 | 0 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/20 or Better @ Month 24 | 46 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/25 or Better @ Month 24 | 60 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/32 or Better @ Month 24 | 63 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/40 or Better @ Month 24 | 66 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Worse than 20/40 @ Month 24 | 1 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/20 or Better @ Month 36 | 27 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/25 or Better @ Month 36 | 34 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/32 or Better @ Month 36 | 42 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/40 or Better @ Month 36 | 43 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Worse than 20/40 @ Month 36 | 0 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/20 or Better @ Month 48 | 33 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/25 or Better @ Month 48 | 43 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/32 or Better @ Month 48 | 50 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/40 or Better @ Month 48 | 52 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | Worse than 20/40 @ Month 48 | 0 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/20 or Better @ Month 60 | 33 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/25 or Better @ Month 60 | 45 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/32 or Better @ Month 60 | 50 subjects |
| Cataract Surgery Only | Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit | 20/40 or Better @ Month 60 | 51 subjects |
Secondary
Number of Subjects Who Reported at Least One Protocol-specified Ocular Adverse Event in the Study Eye
Ocular adverse events in the study eye could include, but were not limited to, BCVA loss of 2 lines (10 letters) or more on the ETDRS chart in comparison with the best BCVA reported in Study Protocol TMI-09-01, endophthalmitis, corneal edema, and corneal decompensation. Inferential testing was not planned for this endpoint.
Time frame: Up to Month 60 postoperative
Population: All enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cataract Surgery + CyPass | Number of Subjects Who Reported at Least One Protocol-specified Ocular Adverse Event in the Study Eye | 60 Subjects |
| Cataract Surgery Only | Number of Subjects Who Reported at Least One Protocol-specified Ocular Adverse Event in the Study Eye | 13 Subjects |
Secondary
Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
The dilated fundus examination was performed by the investigator to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. Clinically significant findings are reported categorically. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 36, 48, 60 postoperative
Population: Subjects with available data at each visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Glaucomatous optic disc atrophy | 1 subjects |
| Cataract Surgery + CyPass | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Macular oedema | 0 subjects |
| Cataract Surgery + CyPass | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Macular fibrosis | 0 subjects |
| Cataract Surgery + CyPass | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Retinal drusen | 0 subjects |
| Cataract Surgery + CyPass | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Macular hole | 0 subjects |
| Cataract Surgery + CyPass | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Optic nerve disorder | 2 subjects |
| Cataract Surgery + CyPass | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Optic atrophy | 0 subjects |
| Cataract Surgery + CyPass | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Neovascular age-related macular degeneration | 0 subjects |
| Cataract Surgery + CyPass | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Dry age-related macular degeneration | 0 subjects |
| Cataract Surgery + CyPass | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Macular degeneration | 0 subjects |
| Cataract Surgery Only | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Macular oedema | 1 subjects |
| Cataract Surgery Only | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Dry age-related macular degeneration | 0 subjects |
| Cataract Surgery Only | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Glaucomatous optic disc atrophy | 3 subjects |
| Cataract Surgery Only | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Macular degeneration | 0 subjects |
| Cataract Surgery Only | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Macular fibrosis | 1 subjects |
| Cataract Surgery Only | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Macular hole | 0 subjects |
| Cataract Surgery Only | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Neovascular age-related macular degeneration | 1 subjects |
| Cataract Surgery Only | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Optic atrophy | 0 subjects |
| Cataract Surgery Only | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Optic nerve disorder | 1 subjects |
| Cataract Surgery Only | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Retinal drusen | 0 subjects |
| Cataract Surgery + CyPass, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Macular oedema | 1 subjects |
| Cataract Surgery + CyPass, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Neovascular age-related macular degeneration | 0 subjects |
| Cataract Surgery + CyPass, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Optic atrophy | 1 subjects |
| Cataract Surgery + CyPass, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Glaucomatous optic disc atrophy | 2 subjects |
| Cataract Surgery + CyPass, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Optic nerve disorder | 1 subjects |
| Cataract Surgery + CyPass, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Dry age-related macular degeneration | 1 subjects |
| Cataract Surgery + CyPass, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Retinal drusen | 1 subjects |
| Cataract Surgery + CyPass, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Macular fibrosis | 1 subjects |
| Cataract Surgery + CyPass, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Macular hole | 1 subjects |
| Cataract Surgery + CyPass, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Macular degeneration | 1 subjects |
| Cataract Surgery Only, Month 36 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Retinal drusen | 1 subjects |
| Cataract Surgery Only, Month 36 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Glaucomatous optic disc atrophy | 0 subjects |
| Cataract Surgery Only, Month 36 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Retinal haemorrhage | 0 subjects |
| Cataract Surgery Only, Month 48 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Retinal haemorrhage | 1 subjects |
| Cataract Surgery Only, Month 48 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Glaucomatous optic disc atrophy | 1 subjects |
| Cataract Surgery Only, Month 48 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Retinal drusen | 1 subjects |
| Cataract Surgery Only, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Retinal haemorrhage | 0 subjects |
| Cataract Surgery Only, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Retinal drusen | 0 subjects |
| Cataract Surgery Only, Month 60 | Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations | Glaucomatous optic disc atrophy | 1 subjects |
Secondary
Number of Subjects With CyPass Device Malposition, Dislodgement or Movement
Device position was a qualitative and subjective assessment by the investigator and evaluated based on visible number of rings of the device under the gonioscopic exam. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. This outcome measure was prespecified for Cataract Surgery + CyPass arm only.
Time frame: Up to 60 months postoperatively
Population: Total number of subjects in the treatment group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cataract Surgery + CyPass | Number of Subjects With CyPass Device Malposition, Dislodgement or Movement | 6 subjects |
Secondary
Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 36, 48, 60 postoperative
Population: All subject eyes with data available at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg | Month 36 | 54.7 percentage of subjects |
| Cataract Surgery + CyPass | Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg | Month 48 | 46.2 percentage of subjects |
| Cataract Surgery + CyPass | Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg | Month 60 | 44.0 percentage of subjects |
| Cataract Surgery Only | Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg | Month 36 | 45.7 percentage of subjects |
| Cataract Surgery Only | Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg | Month 48 | 30.8 percentage of subjects |
| Cataract Surgery Only | Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg | Month 60 | 28.3 percentage of subjects |
Secondary
Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Baseline, Month 36, 48, 60 postoperative
Population: All subject eyes for which data was available at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications | Month 36 | 57.9 percentage of subjects |
| Cataract Surgery + CyPass | Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications | Month 48 | 50.0 percentage of subjects |
| Cataract Surgery + CyPass | Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications | Month 60 | 46.0 percentage of subjects |
| Cataract Surgery Only | Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications | Month 36 | 41.3 percentage of subjects |
| Cataract Surgery Only | Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications | Month 48 | 28.8 percentage of subjects |
| Cataract Surgery Only | Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications | Month 60 | 32.1 percentage of subjects |
Secondary
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells
Inflammatory anterior chamber cells (cells in the front portion of the eye) were assessed by the investigator during slit-lamp examination and reported in one of 6 categories according to cells per 1x1 mm slit: 0-\<1 cell, 1-5 cells, 6-15 cells, 16-25 cells, and 26-50 cells, and \>50 cells. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 36, 48, 60 postoperative
Population: All subjects with available data at that visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells | 0 - < 1 cell at Month 36 | 168 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells | 0 - < 1 cell at Month 48 | 189 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells | 1 - 5 cells at Month 48 | 1 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells | 0 - < 1 cell at Month 60 | 200 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells | 0 - < 1 cell at Month 60 | 53 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells | 0 - < 1 cell at Month 36 | 50 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells | 1 - 5 cells at Month 48 | 0 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells | 0 - < 1 cell at Month 48 | 55 subjects |
Secondary
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare
Anterior Chamber Flare (protein escaping from dilated vessels) was assessed by the investigator during slit-lamp examination and rated on a 5-point scale: None, Faint, Moderate (iris and lens details clear), Marked (iris and lens details hazy), and Intense (fibrin or plastic aqueous). The presence of flare is a sign of intraocular inflammation. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 36, 48, 60 postoperative
Population: All subjects with available data at that visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare | None at Month 36 | 168 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare | None at Month 48 | 190 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare | None at Month 60 | 200 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare | None at Month 36 | 50 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare | None at Month 48 | 55 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare | None at Month 60 | 53 subjects |
Secondary
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema
Corneal Edema (swelling of the cornea) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None (transparent and clear or less than mild), Mild (dull glassy appearance), Moderate (Dull glassy appearance of epithelium with large number of vacuoles), and Severe (epithelial bullae and/or stromal edema, localized or diffuse, with or without stromal striae). Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 36, 48, 60 postoperative
Population: All subjects with available data at that visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema | Mild at Month 36 | 1 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema | None at Month 60 | 199 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema | None at Month 48 | 190 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema | Mild at Month 60 | 1 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema | None at Month 36 | 167 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema | Mild at Month 60 | 0 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema | None at Month 36 | 50 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema | Mild at Month 36 | 0 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema | None at Month 48 | 55 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema | None at Month 60 | 53 subjects |
Secondary
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
Corneal Staining (appearance of tissue disruption and other pathophysiological changes) and erosion (abrasion) were assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None (no fluorescein staining of epithelium, OR less than mild), Mild (slight fluorescein staining confined to a small focus), Moderate (regionally dense fluorescein staining (1 mm or greater in diameter) with underlying structure moderately visible), and Severe (marked fluorescein staining or epithelial loss). Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 36, 48, 60 postoperative
Population: All subjects with available data at that visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Mild at Month 36 | 8 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Moderate at Month 48 | 1 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | None at Month 48 | 181 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | None at Month 60 | 191 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Moderate at Month 36 | 1 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Mild at Month 60 | 6 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Mild at Month 48 | 8 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Moderate at Month 60 | 3 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | None at Month 36 | 159 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Moderate at Month 60 | 0 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | None at Month 36 | 48 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Mild at Month 36 | 2 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Moderate at Month 36 | 0 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | None at Month 48 | 52 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Mild at Month 48 | 3 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Moderate at Month 48 | 0 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | None at Month 60 | 51 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion | Mild at Month 60 | 2 subjects |
Secondary
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion
Iris Atrophy/Erosion (deterioration) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 36, 48, 60 postoperative
Population: All subjects with available data at that visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | None at Month 36 | 163 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | Mild at Month 36 | 1 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | None at Month 48 | 189 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | Mild at Month 48 | 1 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | None at Month 60 | 198 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | Mild at Month 60 | 2 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | None at Month 60 | 53 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | None at Month 36 | 49 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | Mild at Month 48 | 0 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | Mild at Month 36 | 1 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | Mild at Month 60 | 0 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion | None at Month 48 | 55 subjects |
Secondary
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking
Iris Peaking (one part of the iris pulled to a peak resulting in an irregular pupil) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 36, 48, 60 postoperative
Population: All subjects with available data at that visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking | Mild at Month 36 | 1 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking | Mild at Month 48 | 1 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking | None at Month 48 | 188 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking | None at Month 60 | 200 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking | None at Month 36 | 163 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking | None at Month 60 | 53 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking | None at Month 36 | 50 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking | Mild at Month 36 | 0 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking | None at Month 48 | 55 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking | Mild at Month 48 | 0 subjects |
Secondary
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis
Iris Rubeosis (abnormal blood vessels (formed by neovascularization) found on the surface of the iris) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 36, 48, 60 postoperative
Population: All subjects with available data at that visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis | None at Month 36 | 164 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis | None at Month 48 | 190 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis | None at Month 60 | 200 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis | None at Month 36 | 50 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis | None at Month 48 | 55 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis | None at Month 60 | 53 subjects |
Secondary
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
PCO (cloudy layer of scar tissue behind the lens implant) Severity was assessed by the investigator during slit-lamp examination and rated on a 6-point scale: None, Minimal, Mild, Moderate, Severe, and Unspecified. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Time frame: Month 36, 48, 60 postoperative
Population: All subjects with available data at that visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Mild at Month 36 | 17 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Mild at Month 48 | 25 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Unspecified at Month 36 | 3 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Moderate at Month 48 | 4 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Minimal at Month 36 | 27 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | None at Month 60 | 138 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | None at Month 48 | 132 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Minimal at Month 60 | 32 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Moderate at Month 36 | 5 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Mild at Month 60 | 26 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Minimal at Month 48 | 29 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Moderate at Month 60 | 4 subjects |
| Cataract Surgery + CyPass | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | None at Month 36 | 114 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Moderate at Month 60 | 1 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | None at Month 36 | 42 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Minimal at Month 36 | 3 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Mild at Month 36 | 2 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Moderate at Month 36 | 2 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Unspecified at Month 36 | 0 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | None at Month 48 | 43 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Minimal at Month 48 | 8 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Mild at Month 48 | 4 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Moderate at Month 48 | 0 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | None at Month 60 | 41 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Minimal at Month 60 | 7 subjects |
| Cataract Surgery Only | Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity | Mild at Month 60 | 4 subjects |