Aphakia, Cataract, Corneal Astigmatism
Conditions
Keywords
cataract, intraoperative exchange, intraocular lens, astigmatism, toric
Brief summary
The purpose of this study was to demonstrate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic in subjects with pre-existing corneal astigmatism in need of cataract surgery.
Detailed description
Subjects were implanted with the HARMONI® Modular Intraocular Lens System (HMIOL). The eye with the higher corneal astigmatism (study eye) was assigned to Cohort 1 and received the HARMONI® Modular Intraocular Lens System with a toric optic. The fellow eye was assigned to Cohort 2 and received the HARMONI® Modular Intraocular Lens System with a non-toric optic during primary implantation, which was replaced with the appropriate optic power (toric or non-toric) during an intraoperative exchange (IOE) procedure. A total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. The total duration of participation for each subject was up to 6 months, which included a Day -90 to Day -0 preoperative period. Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.
Interventions
DEVICEHARMONI® Modular Intraocular Lens System
Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag
PROCEDUREIntraoperative optic exchange
Removal of one optic and replacement with another during cataract surgery for the purpose of improving refractive outcomes
Sponsors
ClarVista Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria * Willing and able to return for scheduled treatment and follow-up examinations for up to 6 month study duration. * Planned removal of visually significant bilateral cataracts. * Pre-existing corneal astigmatism in at least 1 eye. * Willing to discontinue contact lens wear for the duration of the study. * Best Corrected Visual Acuity (BCVA) projected to be 0.2 logarithm Minimum Angle of Resolution (logMAR) or lower. * Visual symptoms related to cataracts. Key
Exclusion criteria
* History of any intraocular or corneal surgery in either eye (including refractive). * Pregnant or lactating. * History of any clinically significant retinal pathology or ocular diagnosis in either eye that could alter or limit final postoperative visual prognosis. * History of any ocular condition which could affect the stability of the intraocular lens (IOL) in either eye. * Uncontrolled glaucoma in either eye (per Investigator judgement). * Severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL | Month 1 postoperative, Month 3 postoperative | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number, with a less negative number indicating a lesser amount of added correction. No formal statistical hypothesis testing was planned. |
| Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL | Month 1 postoperative, Month 3 postoperative | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. MRCYL PE was calculated as postoperative MRCYL adjusted to 6 meters minus MRCYL target residual refractive error (TRRE), with a lower absolute value indicating a more accurate cylinder power calculation. No formal statistical hypothesis testing was planned. |
| Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL | Baseline (Day 0 preoperative), Month 3 postoperative | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. No formal statistical hypothesis testing was planned. |
| Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL | Baseline (Day 0 preoperative), Month 3 postoperative | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. Therefore, the cylindrical power percent reduction was the cylinder power reduction divided by the absolute value of preoperative magnitude of corneal cylinder (K) × 100. A higher number (greater percent reduction) indicates better astigmatism correction by the toric IOL. No formal statistical hypothesis testing was planned. |
| Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE) | Month 3 postoperative | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). MRSE PE was calculated as postoperative MRSE adjusted to 6 meters minus MRSE target residual refractive error (TRRE). The lower the absolute number, the more accurate the IOL power calculation is. No formal statistical hypothesis testing was planned. |
| Mean Absolute Rotation of IOL Meridian | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees, with a lower number indicating less rotation. No formal statistical hypothesis testing was planned. |
| Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees and is reported categorically. No formal statistical hypothesis testing was planned. |
| Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees and is reported categorically. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Baseline (Day 0 operative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing. BCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | Baseline (Day 0 operative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing. UCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). The Snellen fraction compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). The Snellen fraction compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. |
| Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | Preservation of BCDVA was defined in terms of lines lost when reading the ETDRS chart at each visit compared to the prior best-achieved BCDVA. Loss of \< 1 line included subjects with less than a 1 line loss, no change or improvement in BCDVA. No formal statistical hypothesis testing was planned. |
| Number of Ocular Adverse Events Through Month 3 | Up to Month 3 postoperative | Ocular adverse events were identified as outlined in ISO 11979-2014 Annex B. No formal statistical hypothesis testing was planned. |
| Number of Device Deficiencies Post Implantation | Up to Month 3 postoperative | A Device Deficiency (DD) was defined as a failure of the device to meet its performance specifications or expectations, or otherwise not perform as intended. This could include either a malfunction or damage to the device or any part thereof, regardless of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) to subject, user, or bystander. No formal statistical hypothesis testing was planned. |
| Number of Secondary Surgical Interventions, Other Than Intraroperative Optic Exchange and Rotational Adjustment of the Toric Optic in Cohort 2 | Up to Month 3 postoperative | A secondary surgical intervention (SSI) was defined as a surgical procedure that occurred after primary implantation and was conducted for the purpose of resolving residual refractive error (RRE) and optimizing visual outcomes. No formal statistical hypothesis testing was planned. |
| Percent Change in Endothelial Cell Count (ECC) at Month 3 | Baseline (preoperative), Month 3 postoperative | High quality images of the corneal endothelium (the single layer of cells on the inner surface of the cornea) were taken at the investigative site and sent to an independent central reading center for evaluation. A negative percent change value may indicate a decrease in the ability of the endothelium to maintain its primary function. No formal statistical hypothesis testing was planned. |
Countries
Mexico, Philippines
Participant flow
Recruitment details
This study was conducted at 1 site located in the Philippines and 1 site located in Mexico. Of the 44 subjects signing an informed consent, 12 failed to meet inclusion/exclusion criteria and 5 were withdrawn prior to implantation when the intraocular lens power was not available due to inventory restrictions.
Pre-assignment details
This reporting group includes all implanted subjects/eyes. Note: One eye in Cohort 2 attempted implantation but was discontinued due to capsular instability (preferred term: Ciliary zonular dehiscence), which was reported as an intraoperative SAE.
Participants by arm
| Arm | Count |
|---|---|
| HMIOL Implantation with HMIOL system | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | HMIOL |
|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 10.6 |
| Race/Ethnicity, Customized Asian | 25 Participants |
| Race/Ethnicity, Customized Black | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 1 / 27 |
Outcome results
Primary
Mean Absolute Rotation of IOL Meridian
IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees, with a lower number indicating less rotation. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Mean Absolute Rotation of IOL Meridian | Rotation from operative to Day 1 | 1.8 degrees | Standard Deviation 1.3 |
| Cohort 1 | Mean Absolute Rotation of IOL Meridian | Rotation from operative to Week 1 | 2.4 degrees | Standard Deviation 1.4 |
| Cohort 1 | Mean Absolute Rotation of IOL Meridian | Rotation from operative to Month 1 | 3.1 degrees | Standard Deviation 4.5 |
| Cohort 1 | Mean Absolute Rotation of IOL Meridian | Rotation from operative to Month 3 | 3.2 degrees | Standard Deviation 4.6 |
| Cohort 2 | Mean Absolute Rotation of IOL Meridian | Rotation from operative to Month 3 | 2.2 degrees | Standard Deviation 1.6 |
| Cohort 2 | Mean Absolute Rotation of IOL Meridian | Rotation from operative to Day 1 | 2.1 degrees | Standard Deviation 1.4 |
| Cohort 2 | Mean Absolute Rotation of IOL Meridian | Rotation from operative to Month 1 | 2.3 degrees | Standard Deviation 1.5 |
| Cohort 2 | Mean Absolute Rotation of IOL Meridian | Rotation from operative to Week 1 | 1.6 degrees | Standard Deviation 1.7 |
Primary
Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number, with a less negative number indicating a lesser amount of added correction. No formal statistical hypothesis testing was planned.
Time frame: Month 1 postoperative, Month 3 postoperative
Population: Per Protocol: All eyes with successful implantation of the HMTIOL and no major protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL | Month 1 postoperative | -0.54 diopter | Standard Deviation 0.32 |
| Cohort 1 | Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL | Month 3 postoperative | -0.58 diopter | Standard Deviation 0.42 |
| Cohort 2 | Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL | Month 3 postoperative | -0.72 diopter | Standard Deviation 0.45 |
| Cohort 2 | Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL | Month 1 postoperative | -0.75 diopter | Standard Deviation 0.31 |
Primary
Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. MRCYL PE was calculated as postoperative MRCYL adjusted to 6 meters minus MRCYL target residual refractive error (TRRE), with a lower absolute value indicating a more accurate cylinder power calculation. No formal statistical hypothesis testing was planned.
Time frame: Month 1 postoperative, Month 3 postoperative
Population: Per Protocol: All eyes with successful implantation of the HMTIOL and no major protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL | Month 1 postoperative | -0.30 diopter | Standard Deviation 0.28 |
| Cohort 1 | Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL | Month 3 postoperative | -0.33 diopter | Standard Deviation 0.33 |
| Cohort 2 | Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL | Month 1 postoperative | -0.53 diopter | Standard Deviation 0.36 |
| Cohort 2 | Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL | Month 3 postoperative | -0.44 diopter | Standard Deviation 0.37 |
Primary
Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). MRSE PE was calculated as postoperative MRSE adjusted to 6 meters minus MRSE target residual refractive error (TRRE). The lower the absolute number, the more accurate the IOL power calculation is. No formal statistical hypothesis testing was planned.
Time frame: Month 3 postoperative
Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE) | 0.03 diopter | Standard Deviation 0.45 |
| Cohort 2 | Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE) | -0.12 diopter | Standard Deviation 0.43 |
Primary
Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. Therefore, the cylindrical power percent reduction was the cylinder power reduction divided by the absolute value of preoperative magnitude of corneal cylinder (K) × 100. A higher number (greater percent reduction) indicates better astigmatism correction by the toric IOL. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day 0 preoperative), Month 3 postoperative
Population: Per Protocol: All eyes with successful implantation of the HMTIOL and no major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL | 54.9 percent reduction | Standard Deviation 29.3 |
| Cohort 2 | Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL | 39.5 percent reduction | Standard Deviation 34.2 |
Primary
Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day 0 preoperative), Month 3 postoperative
Population: Per Protocol: All eyes with successful implantation of the HMTIOL and no major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL | 0.79 diopter | Standard Deviation 0.56 |
| Cohort 2 | Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL | 0.53 diopter | Standard Deviation 0.39 |
Primary
Number of Device Deficiencies Post Implantation
A Device Deficiency (DD) was defined as a failure of the device to meet its performance specifications or expectations, or otherwise not perform as intended. This could include either a malfunction or damage to the device or any part thereof, regardless of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) to subject, user, or bystander. No formal statistical hypothesis testing was planned.
Time frame: Up to Month 3 postoperative
Population: All implanted subjects/eyes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Number of Device Deficiencies Post Implantation | 0 device deficiency |
| Cohort 2 | Number of Device Deficiencies Post Implantation | 0 device deficiency |
Primary
Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1
IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees and is reported categorically. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative ≤ 5 degrees | 22 eyes |
| Cohort 1 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative >5 degrees to ≤ 10 degrees | 0 eyes |
| Cohort 1 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative >10 degrees to ≤ 20 degree | 0 eyes |
| Cohort 1 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative > 20 degrees | 0 eyes |
| Cohort 2 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative >5 degrees to ≤ 10 degrees | 0 eyes |
| Cohort 2 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative >10 degrees to ≤ 20 degree | 0 eyes |
| Cohort 2 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative > 20 degrees | 0 eyes |
| Cohort 2 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative ≤ 5 degrees | 23 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative >10 degrees to ≤ 20 degree | 0 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative >5 degrees to ≤ 10 degrees | 0 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative > 20 degrees | 1 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative ≤ 5 degrees | 23 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative > 20 degrees | 1 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative >5 degrees to ≤ 10 degrees | 0 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative ≤ 5 degrees | 22 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | Rotation from Operative >10 degrees to ≤ 20 degree | 0 eyes |
Primary
Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2
IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees and is reported categorically. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative ≤ 5 degrees | 20 eyes |
| Cohort 1 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative >5 degrees to ≤ 10 degrees | 0 eyes |
| Cohort 1 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative >10 degrees to ≤ 20 degree | 0 eyes |
| Cohort 1 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative > 20 degrees | 0 eyes |
| Cohort 2 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative > 20 degrees | 0 eyes |
| Cohort 2 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative >10 degrees to ≤ 20 degree | 0 eyes |
| Cohort 2 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative >5 degrees to ≤ 10 degrees | 0 eyes |
| Cohort 2 | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative ≤ 5 degrees | 17 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative >10 degrees to ≤ 20 degree | 0 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative >5 degrees to ≤ 10 degrees | 0 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative > 20 degrees | 0 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative ≤ 5 degrees | 18 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative ≤ 5 degrees | 19 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative >5 degrees to ≤ 10 degrees | 0 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative > 20 degrees | 0 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | Rotation from Operative >10 degrees to ≤ 20 degree | 0 eyes |
Primary
Number of Eyes With Preservation of BCDVA at Month 1 and Month 3
Preservation of BCDVA was defined in terms of lines lost when reading the ETDRS chart at each visit compared to the prior best-achieved BCDVA. Loss of \< 1 line included subjects with less than a 1 line loss, no change or improvement in BCDVA. No formal statistical hypothesis testing was planned.
Time frame: Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Population: All implanted subjects/eyes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 3 lines | 0 eyes |
| Cohort 1 | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 1 lines | 0 eyes |
| Cohort 1 | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 4 lines | 0 eyes |
| Cohort 1 | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 2 lines | 0 eyes |
| Cohort 1 | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss < 1 line | 27 eyes |
| Cohort 2 | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 2 lines | 1 eyes |
| Cohort 2 | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 3 lines | 0 eyes |
| Cohort 2 | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 4 lines | 0 eyes |
| Cohort 2 | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 1 lines | 2 eyes |
| Cohort 2 | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss < 1 line | 25 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 2 lines | 0 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss < 1 line | 25 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 1 lines | 1 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 3 lines | 0 eyes |
| Cohort 1 - Month 1 Postoperative | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 4 lines | 0 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 3 lines | 0 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 1 lines | 0 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss < 1 line | 26 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 2 lines | 0 eyes |
| Cohort 1 - Month 3 Postoperative | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Loss >= 4 lines | 0 eyes |
Primary
Number of Ocular Adverse Events Through Month 3
Ocular adverse events were identified as outlined in ISO 11979-2014 Annex B. No formal statistical hypothesis testing was planned.
Time frame: Up to Month 3 postoperative
Population: Safety Analysis Set: All subjects/eyes with attempted study lens implantation (successful or aborted).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | Number of Ocular Adverse Events Through Month 3 | Conjunctivitis viral | 1 adverse event |
| Cohort 1 | Number of Ocular Adverse Events Through Month 3 | Cystoid macular oedema | 1 adverse event |
| Cohort 1 | Number of Ocular Adverse Events Through Month 3 | Ciliary zonular dehiscence | 0 adverse event |
| Cohort 1 | Number of Ocular Adverse Events Through Month 3 | Iridocyclitis | 0 adverse event |
| Cohort 1 | Number of Ocular Adverse Events Through Month 3 | Intraocular pressure increased | 0 adverse event |
| Cohort 2 | Number of Ocular Adverse Events Through Month 3 | Ciliary zonular dehiscence | 1 adverse event |
| Cohort 2 | Number of Ocular Adverse Events Through Month 3 | Conjunctivitis viral | 0 adverse event |
| Cohort 2 | Number of Ocular Adverse Events Through Month 3 | Intraocular pressure increased | 1 adverse event |
| Cohort 2 | Number of Ocular Adverse Events Through Month 3 | Cystoid macular oedema | 1 adverse event |
| Cohort 2 | Number of Ocular Adverse Events Through Month 3 | Iridocyclitis | 1 adverse event |
Primary
Number of Secondary Surgical Interventions, Other Than Intraroperative Optic Exchange and Rotational Adjustment of the Toric Optic in Cohort 2
A secondary surgical intervention (SSI) was defined as a surgical procedure that occurred after primary implantation and was conducted for the purpose of resolving residual refractive error (RRE) and optimizing visual outcomes. No formal statistical hypothesis testing was planned.
Time frame: Up to Month 3 postoperative
Population: All implanted subjects/eyes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Number of Secondary Surgical Interventions, Other Than Intraroperative Optic Exchange and Rotational Adjustment of the Toric Optic in Cohort 2 | 0 Secondary surgical interventions |
| Cohort 2 | Number of Secondary Surgical Interventions, Other Than Intraroperative Optic Exchange and Rotational Adjustment of the Toric Optic in Cohort 2 | 0 Secondary surgical interventions |
Primary
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1
Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing. BCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day 0 operative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 92.6 Percentage of eyes |
| Cohort 1 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 51.9 Percentage of eyes |
| Cohort 1 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 7.4 Percentage of eyes |
| Cohort 1 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 70.4 Percentage of eyes |
| Cohort 1 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 22.2 Percentage of eyes |
| Cohort 2 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 96.3 Percentage of eyes |
| Cohort 2 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 100.0 Percentage of eyes |
| Cohort 2 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 0.0 Percentage of eyes |
| Cohort 2 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 77.8 Percentage of eyes |
| Cohort 2 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 66.7 Percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 100.0 Percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 59.3 Percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 85.2 Percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 100.0 Percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 0.0 Percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 96.3 Percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 92.6 Percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 70.4 Percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 96.3 Percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 3.7 Percentage of eyes |
Primary
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2
Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing. UCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day 0 operative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 88.5 percentage of eyes |
| Cohort 1 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 57.7 percentage of eyes |
| Cohort 1 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 11.5 percentage of eyes |
| Cohort 1 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 76.9 percentage of eyes |
| Cohort 1 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 23.1 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 96.2 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 96.2 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 3.8 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 84.6 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 76.9 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 92.3 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 73.1 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 88.5 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 92.3 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 76.9 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 100 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
Primary
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1
Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). The Snellen fraction compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 40.7 percentage of eyes |
| Cohort 1 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 3.7 percentage of eyes |
| Cohort 1 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 59.3 percentage of eyes |
| Cohort 1 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 14.8 percentage of eyes |
| Cohort 1 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 14.8 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 96.3 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 77.8 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 55.6 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 3.7 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 48.1 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 88.9 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 44.4 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 59.3 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 3.7 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 40.7 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 96.3 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 92.6 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 74.1 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 92.6 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 96.3 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 40.7 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 3.7 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 70.4 percentage of eyes |
Primary
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2
Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). The Snellen fraction compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Population: Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 50.0 percentage of eyes |
| Cohort 1 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 0.0 percentage of eyes |
| Cohort 1 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 50.0 percentage of eyes |
| Cohort 1 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 3.8 percentage of eyes |
| Cohort 1 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 11.5 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 92.3 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 65.4 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 65.4 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 7.7 percentage of eyes |
| Cohort 2 | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 46.2 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 84.6 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 53.8 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 76.9 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 92.3 percentage of eyes |
| Cohort 1 - Month 1 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 7.7 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 42.3 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 88.5 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 73.1 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 84.6 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 34.6 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 3 Postoperative | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 69.2 percentage of eyes |
Primary
Percent Change in Endothelial Cell Count (ECC) at Month 3
High quality images of the corneal endothelium (the single layer of cells on the inner surface of the cornea) were taken at the investigative site and sent to an independent central reading center for evaluation. A negative percent change value may indicate a decrease in the ability of the endothelium to maintain its primary function. No formal statistical hypothesis testing was planned.
Time frame: Baseline (preoperative), Month 3 postoperative
Population: All implanted subjects/eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Percent Change in Endothelial Cell Count (ECC) at Month 3 | -12.5 percent change | Standard Deviation 10.1 |
| Cohort 2 | Percent Change in Endothelial Cell Count (ECC) at Month 3 | -9.0 percent change | Standard Deviation 10.3 |