Cataracts
Conditions
Keywords
Cataracts, Intraocular lens, Multifocal, Presbyopia
Brief summary
The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\] in Japanese cataract patients.
Detailed description
Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 8 postoperative visits (each eye examined at Day 1-2, Day 7-14, and Day 30-60, with binocular visits at Day 120-180 and Day 330-420 after the second implantation). The second implantation occurred within 30 days of the first.
Interventions
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign informed consent; * Diagnosed with bilateral cataracts; * Planned cataract removal by phacoemulsification; * Potential postoperative visual acuity of 0.5 decimal or better in both eyes; * Preoperative astigmatism ≤ 1.5 diopter; * Clear intraocular media other than cataract in study eyes; * Calculated lens power within the available range; * Able to undergo second eye surgery within 30 days of the first eye surgery; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Significant irregular corneal aberration as demonstrated by corneal topography; * Any inflammation or edema (swelling) of the cornea; * Diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.5 decimal; * Diabetic retinopathy; * Previous refractive surgery, retinal detachment, corneal transplant; * Glaucoma; * Pregnancy; * Currently participating in another investigational drug or device study; *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Decimal VA (5 m) | Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | Visual acuity (VA) was tested monocularly (each eye separately) at all visits and binocularly (both eyes together) at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. |
| Uncorrected Decimal VA (50 cm) | Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 50 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. |
| Best Corrected Decimal VA (5 m) | Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 5 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. |
| Best Corrected Decimal VA (50 cm) | Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 50 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. |
| Distance-Corrected Decimal VA (50 cm) | Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420 | VA was tested monocularly at the preoperative, Day 30-60, Day 120-180, and Day 330-420 visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart. Distance-corrected VA at 50 cm is the VA at 50 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Best Distance (cm) for Uncorrected Decimal Near VA | Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided using a chart. The participant indicated the distance (cm) at which best near vision was attained. |
| Mean Best Distance (cm) for Distance Corrected Decimal Near VA | Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | VA was tested monocularly at Day 1-2, Day 7-14, Day 30-60, Day 120-180, and Day 330-420 and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction using a chart. The participant indicated the distance (cm) at which best near vision was attained. |
| Best Corrected Far (3 m) Contrast Sensitivity | Day 120-180 from second eye implantation | Far contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 3 m using the Vector Vision CSV 1000 illuminated box (one site) and the Vision Contrast Test System (other site). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). For CSV 1000, contrast sensitivity was not measured at spatial frequency 1.5 cpd because there was no option for this frequency. Raw scores were transformed to logMar (logarithm of the minimum angle of resolution) units. A higher numeric value represents better contrast sensitivity. |
| Uncorrected Decimal VA (1 m) | Day 120-180, Day 330-420 | VA was tested binocularly unaided at a distance of 1 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. |
| Mean Defocus Decimal VA (5 m) | Day 120-180 from second eye implantation | Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction at a distance of 5 m using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. |
| Percentage of Participants With Positive Response, Stereoscopic Vision Test | Day 120-180 from second eye implantation | Stereopsis (the ability to perceive depth and 3-dimensional structure) was assessed binocularly under well-lit conditions at best distance using the Stereo Optical Company, Inc., Original Stereo Fly Test and polarized viewers. The participant was shown a series of symbols, with a positive response defined as correct identification of the 3-dimensional symbol. Responses were recorded for 3 symbols: Fly (easiest to perceive), animal, and circle (hardest to perceive). |
| Percentage of Participants With Positive Response, Quality of Life Questions | Day 120-180 from second eye implantation | The participant completed a questionnaire, indicating (yes/no) if he/she experienced visual difficulty in every-day activities while not wearing spectacles. A positive response was defined as, Yes=visual difficulty. |
| Best Corrected Near (46 cm) Contrast Sensitivity | Day 120-180 from second eye implantation | Near contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 46 cm using the Functional Acuity Contrast Test (FACT). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). Raw scores were transformed to logMar units. A higher numeric value represents better contrast sensitivity. |
| Distance Corrected Decimal VA (1 m) | Day 120-180, Day 330-420 | VA was tested binocularly using a chart. Distance-corrected VA at 1 m is the VA at 1 m measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. |
| Uncorrected Decimal VA (40 cm) | Day 120-180, Day 330-420 | VA was tested binocularly unaided at a distance of 40 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. |
| Distance Corrected Decimal VA (40 cm) | Day 120-180, Day 330-420 | VA was tested binocularly using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. |
| Uncorrected Decimal VA at Best Distance | Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart at the distance of best near vision (cm) as decided by the participant. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited from 2 study sites located in Japan.
Pre-assignment details
Of the 70 subjects enrolled, 6 were discontinued prior to first implantation due to withdrawn consent (1) and meeting exclusion criteria (5). This reporting group includes all implanted subjects (64).
Participants by arm
| Arm | Count |
|---|---|
| SN6AD2 AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\], bilateral implantation | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | SN6AD2 |
|---|---|
| Age, Continuous | 66.7 years STANDARD_DEVIATION 7.2 |
| Age, Customized 60-69 years | 29 participants |
| Age, Customized <60 years | 10 participants |
| Age, Customized 70-79 years | 24 participants |
| Age, Customized ≥ 80 years | 1 participants |
| Region of Enrollment Japan | 64 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 64 |
| serious Total, serious adverse events | 3 / 64 |
Outcome results
Primary
Best Corrected Decimal VA (50 cm)
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 50 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative | Best Corrected Decimal VA (50 cm) | First Eye 0.7 to less than 1.0 decimal | 12 participants |
| Preoperative | Best Corrected Decimal VA (50 cm) | Second Eye 0.5 to less than 0.7 decimal | 19 participants |
| Preoperative | Best Corrected Decimal VA (50 cm) | Second Eye worse than 0.5 decimal | 11 participants |
| Preoperative | Best Corrected Decimal VA (50 cm) | Binocular 0.7 to less than 1.0 decimal | NA participants |
| Preoperative | Best Corrected Decimal VA (50 cm) | Second Eye 1.0 decimal or better | 17 participants |
| Preoperative | Best Corrected Decimal VA (50 cm) | First Eye 1.0 decimal or better | 11 participants |
| Preoperative | Best Corrected Decimal VA (50 cm) | Second Eye 0.7 to less than 1.0 decimal | 17 participants |
| Preoperative | Best Corrected Decimal VA (50 cm) | First Eye 0.5 to less than 0.7 decimal | 19 participants |
| Preoperative | Best Corrected Decimal VA (50 cm) | Binocular 0.5 to less than 0.7 decimal | NA participants |
| Preoperative | Best Corrected Decimal VA (50 cm) | First Eye worse than 0.5 decimal | 22 participants |
| Preoperative | Best Corrected Decimal VA (50 cm) | Binocular worse than 0.5 decimal | NA participants |
| Preoperative | Best Corrected Decimal VA (50 cm) | Binocular 1.0 decimal or better | NA participants |
| Day 1-2 | Best Corrected Decimal VA (50 cm) | First Eye 1.0 decimal or better | 5 participants |
| Day 1-2 | Best Corrected Decimal VA (50 cm) | Second Eye 1.0 decimal or better | 10 participants |
| Day 1-2 | Best Corrected Decimal VA (50 cm) | First Eye 0.5 to less than 0.7 decimal | 22 participants |
| Day 1-2 | Best Corrected Decimal VA (50 cm) | Binocular 1.0 decimal or better | NA participants |
| Day 1-2 | Best Corrected Decimal VA (50 cm) | First Eye 0.7 to less than 1.0 decimal | 30 participants |
| Day 1-2 | Best Corrected Decimal VA (50 cm) | Binocular 0.7 to less than 1.0 decimal | NA participants |
| Day 1-2 | Best Corrected Decimal VA (50 cm) | Second Eye 0.7 to less than 1.0 decimal | 28 participants |
| Day 1-2 | Best Corrected Decimal VA (50 cm) | First Eye worse than 0.5 decimal | 7 participants |
| Day 1-2 | Best Corrected Decimal VA (50 cm) | Second Eye worse than 0.5 decimal | 4 participants |
| Day 1-2 | Best Corrected Decimal VA (50 cm) | Binocular 0.5 to less than 0.7 decimal | NA participants |
| Day 1-2 | Best Corrected Decimal VA (50 cm) | Second Eye 0.5 to less than 0.7 decimal | 22 participants |
| Day 1-2 | Best Corrected Decimal VA (50 cm) | Binocular worse than 0.5 decimal | NA participants |
| Day 7-14 | Best Corrected Decimal VA (50 cm) | Binocular 1.0 decimal or better | NA participants |
| Day 7-14 | Best Corrected Decimal VA (50 cm) | Second Eye worse than 0.5 decimal | 0 participants |
| Day 7-14 | Best Corrected Decimal VA (50 cm) | First Eye worse than 0.5 decimal | 1 participants |
| Day 7-14 | Best Corrected Decimal VA (50 cm) | Binocular worse than 0.5 decimal | NA participants |
| Day 7-14 | Best Corrected Decimal VA (50 cm) | First Eye 0.5 to less than 0.7 decimal | 9 participants |
| Day 7-14 | Best Corrected Decimal VA (50 cm) | Second Eye 1.0 decimal or better | 15 participants |
| Day 7-14 | Best Corrected Decimal VA (50 cm) | Second Eye 0.7 to less than 1.0 decimal | 43 participants |
| Day 7-14 | Best Corrected Decimal VA (50 cm) | First Eye 1.0 decimal or better | 16 participants |
| Day 7-14 | Best Corrected Decimal VA (50 cm) | Second Eye 0.5 to less than 0.7 decimal | 6 participants |
| Day 7-14 | Best Corrected Decimal VA (50 cm) | Binocular 0.7 to less than 1.0 decimal | NA participants |
| Day 7-14 | Best Corrected Decimal VA (50 cm) | Binocular 0.5 to less than 0.7 decimal | NA participants |
| Day 7-14 | Best Corrected Decimal VA (50 cm) | First Eye 0.7 to less than 1.0 decimal | 38 participants |
| Day 30-60 | Best Corrected Decimal VA (50 cm) | First Eye 0.7 to less than 1.0 decimal | 39 participants |
| Day 30-60 | Best Corrected Decimal VA (50 cm) | First Eye worse than 0.5 decimal | 0 participants |
| Day 30-60 | Best Corrected Decimal VA (50 cm) | First Eye 0.5 to less than 0.7 decimal | 7 participants |
| Day 30-60 | Best Corrected Decimal VA (50 cm) | First Eye 1.0 decimal or better | 18 participants |
| Day 30-60 | Best Corrected Decimal VA (50 cm) | Second Eye worse than 0.5 decimal | 0 participants |
| Day 30-60 | Best Corrected Decimal VA (50 cm) | Second Eye 0.5 to less than 0.7 decimal | 3 participants |
| Day 30-60 | Best Corrected Decimal VA (50 cm) | Second Eye 0.7 to less than 1.0 decimal | 42 participants |
| Day 30-60 | Best Corrected Decimal VA (50 cm) | Second Eye 1.0 decimal or better | 19 participants |
| Day 30-60 | Best Corrected Decimal VA (50 cm) | Binocular worse than 0.5 decimal | 0 participants |
| Day 30-60 | Best Corrected Decimal VA (50 cm) | Binocular 0.5 to less than 0.7 decimal | 0 participants |
| Day 30-60 | Best Corrected Decimal VA (50 cm) | Binocular 0.7 to less than 1.0 decimal | 29 participants |
| Day 30-60 | Best Corrected Decimal VA (50 cm) | Binocular 1.0 decimal or better | 35 participants |
| Day 120-180 | Best Corrected Decimal VA (50 cm) | First Eye worse than 0.5 decimal | 0 participants |
| Day 120-180 | Best Corrected Decimal VA (50 cm) | First Eye 0.7 to less than 1.0 decimal | 35 participants |
| Day 120-180 | Best Corrected Decimal VA (50 cm) | Second Eye worse than 0.5 decimal | 1 participants |
| Day 120-180 | Best Corrected Decimal VA (50 cm) | Binocular 0.7 to less than 1.0 decimal | 26 participants |
| Day 120-180 | Best Corrected Decimal VA (50 cm) | Binocular worse than 0.5 decimal | 0 participants |
| Day 120-180 | Best Corrected Decimal VA (50 cm) | Binocular 1.0 decimal or better | 36 participants |
| Day 120-180 | Best Corrected Decimal VA (50 cm) | First Eye 0.5 to less than 0.7 decimal | 8 participants |
| Day 120-180 | Best Corrected Decimal VA (50 cm) | Binocular 0.5 to less than 0.7 decimal | 2 participants |
| Day 120-180 | Best Corrected Decimal VA (50 cm) | Second Eye 0.5 to less than 0.7 decimal | 4 participants |
| Day 120-180 | Best Corrected Decimal VA (50 cm) | Second Eye 1.0 decimal or better | 22 participants |
| Day 120-180 | Best Corrected Decimal VA (50 cm) | First Eye 1.0 decimal or better | 21 participants |
| Day 120-180 | Best Corrected Decimal VA (50 cm) | Second Eye 0.7 to less than 1.0 decimal | 37 participants |
| Day 330-420 | Best Corrected Decimal VA (50 cm) | First Eye 0.7 to less than 1.0 decimal | 32 participants |
| Day 330-420 | Best Corrected Decimal VA (50 cm) | Binocular worse than 0.5 decimal | 0 participants |
| Day 330-420 | Best Corrected Decimal VA (50 cm) | Second Eye worse than 0.5 decimal | 1 participants |
| Day 330-420 | Best Corrected Decimal VA (50 cm) | First Eye 1.0 decimal or better | 25 participants |
| Day 330-420 | Best Corrected Decimal VA (50 cm) | Binocular 0.5 to less than 0.7 decimal | 2 participants |
| Day 330-420 | Best Corrected Decimal VA (50 cm) | Second Eye 0.5 to less than 0.7 decimal | 4 participants |
| Day 330-420 | Best Corrected Decimal VA (50 cm) | Binocular 1.0 decimal or better | 44 participants |
| Day 330-420 | Best Corrected Decimal VA (50 cm) | Binocular 0.7 to less than 1.0 decimal | 17 participants |
| Day 330-420 | Best Corrected Decimal VA (50 cm) | First Eye 0.5 to less than 0.7 decimal | 5 participants |
| Day 330-420 | Best Corrected Decimal VA (50 cm) | Second Eye 0.7 to less than 1.0 decimal | 28 participants |
| Day 330-420 | Best Corrected Decimal VA (50 cm) | First Eye worse than 0.5 decimal | 1 participants |
| Day 330-420 | Best Corrected Decimal VA (50 cm) | Second Eye 1.0 decimal or better | 30 participants |
Primary
Best Corrected Decimal VA (5 m)
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 5 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative | Best Corrected Decimal VA (5 m) | Second Eye worse than 0.5 decimal | 15 participants |
| Preoperative | Best Corrected Decimal VA (5 m) | First Eye 1.0 decimal or better | 14 participants |
| Preoperative | Best Corrected Decimal VA (5 m) | First Eye 0.7 to less than 1.0 decimal | 10 participants |
| Preoperative | Best Corrected Decimal VA (5 m) | First Eye worse than 0.5 decimal | 22 participants |
| Preoperative | Best Corrected Decimal VA (5 m) | Binocular worse than 0.5 decimal | NA participants |
| Preoperative | Best Corrected Decimal VA (5 m) | Binocular 0.7 to less than 1.0 decimal | NA participants |
| Preoperative | Best Corrected Decimal VA (5 m) | Binocular 0.5 to less than 0.7 decimal | NA participants |
| Preoperative | Best Corrected Decimal VA (5 m) | Second Eye 1.0 decimal or better | 21 participants |
| Preoperative | Best Corrected Decimal VA (5 m) | Second Eye 0.7 to less than 1.0 decimal | 17 participants |
| Preoperative | Best Corrected Decimal VA (5 m) | First Eye 0.5 to less than 0.7 decimal | 18 participants |
| Preoperative | Best Corrected Decimal VA (5 m) | Binocular 1.0 decimal or better | NA participants |
| Preoperative | Best Corrected Decimal VA (5 m) | Second Eye 0.5 to less than 0.7 decimal | 11 participants |
| Day 1-2 | Best Corrected Decimal VA (5 m) | Binocular 0.5 to less than 0.7 decimal | NA participants |
| Day 1-2 | Best Corrected Decimal VA (5 m) | First Eye worse than 0.5 decimal | 0 participants |
| Day 1-2 | Best Corrected Decimal VA (5 m) | First Eye 0.5 to less than 0.7 decimal | 3 participants |
| Day 1-2 | Best Corrected Decimal VA (5 m) | First Eye 0.7 to less than 1.0 decimal | 14 participants |
| Day 1-2 | Best Corrected Decimal VA (5 m) | First Eye 1.0 decimal or better | 47 participants |
| Day 1-2 | Best Corrected Decimal VA (5 m) | Second Eye worse than 0.5 decimal | 0 participants |
| Day 1-2 | Best Corrected Decimal VA (5 m) | Second Eye 0.7 to less than 1.0 decimal | 17 participants |
| Day 1-2 | Best Corrected Decimal VA (5 m) | Second Eye 1.0 decimal or better | 47 participants |
| Day 1-2 | Best Corrected Decimal VA (5 m) | Binocular worse than 0.5 decimal | NA participants |
| Day 1-2 | Best Corrected Decimal VA (5 m) | Binocular 0.7 to less than 1.0 decimal | NA participants |
| Day 1-2 | Best Corrected Decimal VA (5 m) | Binocular 1.0 decimal or better | NA participants |
| Day 1-2 | Best Corrected Decimal VA (5 m) | Second Eye 0.5 to less than 0.7 decimal | 0 participants |
| Day 7-14 | Best Corrected Decimal VA (5 m) | Binocular 0.5 to less than 0.7 decimal | NA participants |
| Day 7-14 | Best Corrected Decimal VA (5 m) | Binocular worse than 0.5 decimal | NA participants |
| Day 7-14 | Best Corrected Decimal VA (5 m) | Second Eye 1.0 decimal or better | 61 participants |
| Day 7-14 | Best Corrected Decimal VA (5 m) | Binocular 1.0 decimal or better | NA participants |
| Day 7-14 | Best Corrected Decimal VA (5 m) | Second Eye 0.7 to less than 1.0 decimal | 3 participants |
| Day 7-14 | Best Corrected Decimal VA (5 m) | Second Eye worse than 0.5 decimal | 0 participants |
| Day 7-14 | Best Corrected Decimal VA (5 m) | First Eye 1.0 decimal or better | 61 participants |
| Day 7-14 | Best Corrected Decimal VA (5 m) | Binocular 0.7 to less than 1.0 decimal | NA participants |
| Day 7-14 | Best Corrected Decimal VA (5 m) | First Eye worse than 0.5 decimal | 0 participants |
| Day 7-14 | Best Corrected Decimal VA (5 m) | First Eye 0.5 to less than 0.7 decimal | 0 participants |
| Day 7-14 | Best Corrected Decimal VA (5 m) | Second Eye 0.5 to less than 0.7 decimal | 0 participants |
| Day 7-14 | Best Corrected Decimal VA (5 m) | First Eye 0.7 to less than 1.0 decimal | 3 participants |
| Day 30-60 | Best Corrected Decimal VA (5 m) | First Eye 1.0 decimal or better | 61 participants |
| Day 30-60 | Best Corrected Decimal VA (5 m) | First Eye 0.5 to less than 0.7 decimal | 0 participants |
| Day 30-60 | Best Corrected Decimal VA (5 m) | Binocular worse than 0.5 decimal | 0 participants |
| Day 30-60 | Best Corrected Decimal VA (5 m) | Second Eye worse than 0.5 decimal | 0 participants |
| Day 30-60 | Best Corrected Decimal VA (5 m) | Second Eye 0.5 to less than 0.7 decimal | 0 participants |
| Day 30-60 | Best Corrected Decimal VA (5 m) | Second Eye 0.7 to less than 1.0 decimal | 2 participants |
| Day 30-60 | Best Corrected Decimal VA (5 m) | Binocular 1.0 decimal or better | 64 participants |
| Day 30-60 | Best Corrected Decimal VA (5 m) | Second Eye 1.0 decimal or better | 62 participants |
| Day 30-60 | Best Corrected Decimal VA (5 m) | First Eye worse than 0.5 decimal | 0 participants |
| Day 30-60 | Best Corrected Decimal VA (5 m) | Binocular 0.5 to less than 0.7 decimal | 0 participants |
| Day 30-60 | Best Corrected Decimal VA (5 m) | Binocular 0.7 to less than 1.0 decimal | 0 participants |
| Day 30-60 | Best Corrected Decimal VA (5 m) | First Eye 0.7 to less than 1.0 decimal | 3 participants |
| Day 120-180 | Best Corrected Decimal VA (5 m) | First Eye 0.7 to less than 1.0 decimal | 2 participants |
| Day 120-180 | Best Corrected Decimal VA (5 m) | Binocular 1.0 decimal or better | 63 participants |
| Day 120-180 | Best Corrected Decimal VA (5 m) | Second Eye 0.5 to less than 0.7 decimal | 0 participants |
| Day 120-180 | Best Corrected Decimal VA (5 m) | First Eye 0.5 to less than 0.7 decimal | 1 participants |
| Day 120-180 | Best Corrected Decimal VA (5 m) | Binocular 0.5 to less than 0.7 decimal | 0 participants |
| Day 120-180 | Best Corrected Decimal VA (5 m) | Second Eye worse than 0.5 decimal | 0 participants |
| Day 120-180 | Best Corrected Decimal VA (5 m) | Binocular worse than 0.5 decimal | 0 participants |
| Day 120-180 | Best Corrected Decimal VA (5 m) | Binocular 0.7 to less than 1.0 decimal | 1 participants |
| Day 120-180 | Best Corrected Decimal VA (5 m) | Second Eye 0.7 to less than 1.0 decimal | 1 participants |
| Day 120-180 | Best Corrected Decimal VA (5 m) | First Eye worse than 0.5 decimal | 0 participants |
| Day 120-180 | Best Corrected Decimal VA (5 m) | First Eye 1.0 decimal or better | 61 participants |
| Day 120-180 | Best Corrected Decimal VA (5 m) | Second Eye 1.0 decimal or better | 63 participants |
| Day 330-420 | Best Corrected Decimal VA (5 m) | First Eye 1.0 decimal or better | 59 participants |
| Day 330-420 | Best Corrected Decimal VA (5 m) | Second Eye 1.0 decimal or better | 61 participants |
| Day 330-420 | Best Corrected Decimal VA (5 m) | First Eye worse than 0.5 decimal | 0 participants |
| Day 330-420 | Best Corrected Decimal VA (5 m) | Binocular worse than 0.5 decimal | 0 participants |
| Day 330-420 | Best Corrected Decimal VA (5 m) | First Eye 0.7 to less than 1.0 decimal | 4 participants |
| Day 330-420 | Best Corrected Decimal VA (5 m) | Second Eye 0.5 to less than 0.7 decimal | 0 participants |
| Day 330-420 | Best Corrected Decimal VA (5 m) | Second Eye 0.7 to less than 1.0 decimal | 2 participants |
| Day 330-420 | Best Corrected Decimal VA (5 m) | First Eye 0.5 to less than 0.7 decimal | 0 participants |
| Day 330-420 | Best Corrected Decimal VA (5 m) | Binocular 0.7 to less than 1.0 decimal | 1 participants |
| Day 330-420 | Best Corrected Decimal VA (5 m) | Binocular 0.5 to less than 0.7 decimal | 0 participants |
| Day 330-420 | Best Corrected Decimal VA (5 m) | Second Eye worse than 0.5 decimal | 0 participants |
| Day 330-420 | Best Corrected Decimal VA (5 m) | Binocular 1.0 decimal or better | 62 participants |
Primary
Distance-Corrected Decimal VA (50 cm)
VA was tested monocularly at the preoperative, Day 30-60, Day 120-180, and Day 330-420 visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart. Distance-corrected VA at 50 cm is the VA at 50 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time frame: Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative | Distance-Corrected Decimal VA (50 cm) | First Eye 0.4 decimal or better | 16 participants |
| Preoperative | Distance-Corrected Decimal VA (50 cm) | Second Eye worse than 0.4 decimal | 43 participants |
| Preoperative | Distance-Corrected Decimal VA (50 cm) | Second Eye 0.4 decimal or better | 21 participants |
| Preoperative | Distance-Corrected Decimal VA (50 cm) | Binocular worse than 0.4 decimal | NA participants |
| Preoperative | Distance-Corrected Decimal VA (50 cm) | Binocular 0.4 decimal or better | NA participants |
| Preoperative | Distance-Corrected Decimal VA (50 cm) | First Eye worse than 0.4 decimal | 48 participants |
| Day 1-2 | Distance-Corrected Decimal VA (50 cm) | First Eye worse than 0.4 decimal | 4 participants |
| Day 1-2 | Distance-Corrected Decimal VA (50 cm) | Binocular 0.4 decimal or better | 64 participants |
| Day 1-2 | Distance-Corrected Decimal VA (50 cm) | First Eye 0.4 decimal or better | 60 participants |
| Day 1-2 | Distance-Corrected Decimal VA (50 cm) | Second Eye worse than 0.4 decimal | 4 participants |
| Day 1-2 | Distance-Corrected Decimal VA (50 cm) | Second Eye 0.4 decimal or better | 60 participants |
| Day 1-2 | Distance-Corrected Decimal VA (50 cm) | Binocular worse than 0.4 decimal | 0 participants |
| Day 7-14 | Distance-Corrected Decimal VA (50 cm) | Second Eye 0.4 decimal or better | 60 participants |
| Day 7-14 | Distance-Corrected Decimal VA (50 cm) | First Eye worse than 0.4 decimal | 4 participants |
| Day 7-14 | Distance-Corrected Decimal VA (50 cm) | First Eye 0.4 decimal or better | 60 participants |
| Day 7-14 | Distance-Corrected Decimal VA (50 cm) | Binocular worse than 0.4 decimal | 2 participants |
| Day 7-14 | Distance-Corrected Decimal VA (50 cm) | Binocular 0.4 decimal or better | 62 participants |
| Day 7-14 | Distance-Corrected Decimal VA (50 cm) | Second Eye worse than 0.4 decimal | 4 participants |
| Day 30-60 | Distance-Corrected Decimal VA (50 cm) | Binocular worse than 0.4 decimal | 1 participants |
| Day 30-60 | Distance-Corrected Decimal VA (50 cm) | First Eye worse than 0.4 decimal | 2 participants |
| Day 30-60 | Distance-Corrected Decimal VA (50 cm) | Second Eye worse than 0.4 decimal | 2 participants |
| Day 30-60 | Distance-Corrected Decimal VA (50 cm) | Second Eye 0.4 decimal or better | 61 participants |
| Day 30-60 | Distance-Corrected Decimal VA (50 cm) | First Eye 0.4 decimal or better | 61 participants |
| Day 30-60 | Distance-Corrected Decimal VA (50 cm) | Binocular 0.4 decimal or better | 62 participants |
Primary
Uncorrected Decimal VA (50 cm)
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 50 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative | Uncorrected Decimal VA (50 cm) | First Eye 0.4 decimal or better | 15 participants |
| Preoperative | Uncorrected Decimal VA (50 cm) | Binocular 0.4 decimal or better | NA participants |
| Preoperative | Uncorrected Decimal VA (50 cm) | Second Eye 0.4 decimal or better | 20 participants |
| Preoperative | Uncorrected Decimal VA (50 cm) | First Eye worse than 0.4 decimal | 49 participants |
| Preoperative | Uncorrected Decimal VA (50 cm) | Second Eye worse than 0.4 decimal | 44 participants |
| Preoperative | Uncorrected Decimal VA (50 cm) | Binocular worse than 0.4 decimal | NA participants |
| Day 1-2 | Uncorrected Decimal VA (50 cm) | First Eye worse than 0.4 decimal | 12 participants |
| Day 1-2 | Uncorrected Decimal VA (50 cm) | Second Eye worse than 0.4 decimal | 11 participants |
| Day 1-2 | Uncorrected Decimal VA (50 cm) | Binocular 0.4 decimal or better | NA participants |
| Day 1-2 | Uncorrected Decimal VA (50 cm) | First Eye 0.4 decimal or better | 52 participants |
| Day 1-2 | Uncorrected Decimal VA (50 cm) | Second Eye 0.4 decimal or better | 53 participants |
| Day 1-2 | Uncorrected Decimal VA (50 cm) | Binocular worse than 0.4 decimal | NA participants |
| Day 7-14 | Uncorrected Decimal VA (50 cm) | First Eye worse than 0.4 decimal | 6 participants |
| Day 7-14 | Uncorrected Decimal VA (50 cm) | Second Eye worse than 0.4 decimal | 4 participants |
| Day 7-14 | Uncorrected Decimal VA (50 cm) | First Eye 0.4 decimal or better | 58 participants |
| Day 7-14 | Uncorrected Decimal VA (50 cm) | Binocular 0.4 decimal or better | NA participants |
| Day 7-14 | Uncorrected Decimal VA (50 cm) | Binocular worse than 0.4 decimal | NA participants |
| Day 7-14 | Uncorrected Decimal VA (50 cm) | Second Eye 0.4 decimal or better | 60 participants |
| Day 30-60 | Uncorrected Decimal VA (50 cm) | Binocular 0.4 decimal or better | 62 participants |
| Day 30-60 | Uncorrected Decimal VA (50 cm) | First Eye 0.4 decimal or better | 60 participants |
| Day 30-60 | Uncorrected Decimal VA (50 cm) | Second Eye worse than 0.4 decimal | 3 participants |
| Day 30-60 | Uncorrected Decimal VA (50 cm) | Second Eye 0.4 decimal or better | 61 participants |
| Day 30-60 | Uncorrected Decimal VA (50 cm) | Binocular worse than 0.4 decimal | 2 participants |
| Day 30-60 | Uncorrected Decimal VA (50 cm) | First Eye worse than 0.4 decimal | 4 participants |
| Day 120-180 | Uncorrected Decimal VA (50 cm) | Binocular worse than 0.4 decimal | 2 participants |
| Day 120-180 | Uncorrected Decimal VA (50 cm) | First Eye worse than 0.4 decimal | 5 participants |
| Day 120-180 | Uncorrected Decimal VA (50 cm) | Second Eye 0.4 decimal or better | 59 participants |
| Day 120-180 | Uncorrected Decimal VA (50 cm) | Binocular 0.4 decimal or better | 62 participants |
| Day 120-180 | Uncorrected Decimal VA (50 cm) | First Eye 0.4 decimal or better | 59 participants |
| Day 120-180 | Uncorrected Decimal VA (50 cm) | Second Eye worse than 0.4 decimal | 5 participants |
| Day 330-420 | Uncorrected Decimal VA (50 cm) | Binocular 0.4 decimal or better | 63 participants |
| Day 330-420 | Uncorrected Decimal VA (50 cm) | Binocular worse than 0.4 decimal | 0 participants |
| Day 330-420 | Uncorrected Decimal VA (50 cm) | Second Eye 0.4 decimal or better | 60 participants |
| Day 330-420 | Uncorrected Decimal VA (50 cm) | First Eye worse than 0.4 decimal | 2 participants |
| Day 330-420 | Uncorrected Decimal VA (50 cm) | Second Eye worse than 0.4 decimal | 3 participants |
| Day 330-420 | Uncorrected Decimal VA (50 cm) | First Eye 0.4 decimal or better | 61 participants |
Primary
Uncorrected Decimal VA (5 m)
Visual acuity (VA) was tested monocularly (each eye separately) at all visits and binocularly (both eyes together) at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative | Uncorrected Decimal VA (5 m) | Second Eye 0.5 to less than 0.7 decimal | 5 participants |
| Preoperative | Uncorrected Decimal VA (5 m) | Second Eye 1.0 decimal or better | 2 participants |
| Preoperative | Uncorrected Decimal VA (5 m) | Second Eye 0.7 to less than 1.0 decimal | 8 participants |
| Preoperative | Uncorrected Decimal VA (5 m) | Binocular 1.0 decimal or better | NA participants |
| Preoperative | Uncorrected Decimal VA (5 m) | First Eye 0.5 to less than 0.7 decimal | 9 participants |
| Preoperative | Uncorrected Decimal VA (5 m) | Binocular 0.7 to less than 1.0 decimal | NA participants |
| Preoperative | Uncorrected Decimal VA (5 m) | First Eye 0.7 to less than1.0 decimal | 6 participants |
| Preoperative | Uncorrected Decimal VA (5 m) | First Eye 1.0 decimal or better | 1 participants |
| Preoperative | Uncorrected Decimal VA (5 m) | Binocular 0.5 to less than 0.7 decimal | NA participants |
| Preoperative | Uncorrected Decimal VA (5 m) | Second Eye worse than 0.5 decimal | 49 participants |
| Preoperative | Uncorrected Decimal VA (5 m) | First Eye worse than 0.5 decimal | 48 participants |
| Preoperative | Uncorrected Decimal VA (5 m) | Binocular worse than 0.5 decimal | NA participants |
| Day 1-2 | Uncorrected Decimal VA (5 m) | First Eye 0.5 to less than 0.7 decimal | 9 participants |
| Day 1-2 | Uncorrected Decimal VA (5 m) | Binocular 1.0 decimal or better | NA participants |
| Day 1-2 | Uncorrected Decimal VA (5 m) | Binocular 0.7 to less than 1.0 decimal | NA participants |
| Day 1-2 | Uncorrected Decimal VA (5 m) | Binocular worse than 0.5 decimal | NA participants |
| Day 1-2 | Uncorrected Decimal VA (5 m) | First Eye 0.7 to less than1.0 decimal | 22 participants |
| Day 1-2 | Uncorrected Decimal VA (5 m) | Second Eye 0.7 to less than 1.0 decimal | 21 participants |
| Day 1-2 | Uncorrected Decimal VA (5 m) | Binocular 0.5 to less than 0.7 decimal | NA participants |
| Day 1-2 | Uncorrected Decimal VA (5 m) | Second Eye worse than 0.5 decimal | 7 participants |
| Day 1-2 | Uncorrected Decimal VA (5 m) | Second Eye 0.5 to less than 0.7 decimal | 7 participants |
| Day 1-2 | Uncorrected Decimal VA (5 m) | First Eye worse than 0.5 decimal | 3 participants |
| Day 1-2 | Uncorrected Decimal VA (5 m) | Second Eye 1.0 decimal or better | 29 participants |
| Day 1-2 | Uncorrected Decimal VA (5 m) | First Eye 1.0 decimal or better | 30 participants |
| Day 7-14 | Uncorrected Decimal VA (5 m) | First Eye worse than 0.5 decimal | 1 participants |
| Day 7-14 | Uncorrected Decimal VA (5 m) | First Eye 0.5 to less than 0.7 decimal | 6 participants |
| Day 7-14 | Uncorrected Decimal VA (5 m) | Binocular 1.0 decimal or better | NA participants |
| Day 7-14 | Uncorrected Decimal VA (5 m) | Second Eye 0.5 to less than 0.7 decimal | 8 participants |
| Day 7-14 | Uncorrected Decimal VA (5 m) | Second Eye worse than 0.5 decimal | 1 participants |
| Day 7-14 | Uncorrected Decimal VA (5 m) | Second Eye 0.7 to less than 1.0 decimal | 17 participants |
| Day 7-14 | Uncorrected Decimal VA (5 m) | Second Eye 1.0 decimal or better | 38 participants |
| Day 7-14 | Uncorrected Decimal VA (5 m) | Binocular 0.7 to less than 1.0 decimal | NA participants |
| Day 7-14 | Uncorrected Decimal VA (5 m) | First Eye 0.7 to less than1.0 decimal | 17 participants |
| Day 7-14 | Uncorrected Decimal VA (5 m) | Binocular worse than 0.5 decimal | NA participants |
| Day 7-14 | Uncorrected Decimal VA (5 m) | Binocular 0.5 to less than 0.7 decimal | NA participants |
| Day 7-14 | Uncorrected Decimal VA (5 m) | First Eye 1.0 decimal or better | 40 participants |
| Day 30-60 | Uncorrected Decimal VA (5 m) | First Eye 1.0 decimal or better | 36 participants |
| Day 30-60 | Uncorrected Decimal VA (5 m) | Binocular worse than 0.5 decimal | 0 participants |
| Day 30-60 | Uncorrected Decimal VA (5 m) | First Eye worse than 0.5 decimal | 0 participants |
| Day 30-60 | Uncorrected Decimal VA (5 m) | First Eye 0.5 to less than 0.7 decimal | 9 participants |
| Day 30-60 | Uncorrected Decimal VA (5 m) | First Eye 0.7 to less than1.0 decimal | 19 participants |
| Day 30-60 | Uncorrected Decimal VA (5 m) | Second Eye worse than 0.5 decimal | 0 participants |
| Day 30-60 | Uncorrected Decimal VA (5 m) | Second Eye 0.5 to less than 0.7 decimal | 7 participants |
| Day 30-60 | Uncorrected Decimal VA (5 m) | Second Eye 0.7 to less than 1.0 decimal | 21 participants |
| Day 30-60 | Uncorrected Decimal VA (5 m) | Second Eye 1.0 decimal or better | 36 participants |
| Day 30-60 | Uncorrected Decimal VA (5 m) | Binocular 0.5 to less than 0.7 decimal | 2 participants |
| Day 30-60 | Uncorrected Decimal VA (5 m) | Binocular 0.7 to less than 1.0 decimal | 14 participants |
| Day 30-60 | Uncorrected Decimal VA (5 m) | Binocular 1.0 decimal or better | 48 participants |
| Day 120-180 | Uncorrected Decimal VA (5 m) | First Eye 1.0 decimal or better | 37 participants |
| Day 120-180 | Uncorrected Decimal VA (5 m) | Second Eye worse than 0.5 decimal | 0 participants |
| Day 120-180 | Uncorrected Decimal VA (5 m) | First Eye 0.5 to less than 0.7 decimal | 7 participants |
| Day 120-180 | Uncorrected Decimal VA (5 m) | Second Eye 1.0 decimal or better | 41 participants |
| Day 120-180 | Uncorrected Decimal VA (5 m) | Binocular 1.0 decimal or better | 50 participants |
| Day 120-180 | Uncorrected Decimal VA (5 m) | Binocular 0.7 to less than 1.0 decimal | 14 participants |
| Day 120-180 | Uncorrected Decimal VA (5 m) | First Eye 0.7 to less than1.0 decimal | 20 participants |
| Day 120-180 | Uncorrected Decimal VA (5 m) | First Eye worse than 0.5 decimal | 0 participants |
| Day 120-180 | Uncorrected Decimal VA (5 m) | Second Eye 0.7 to less than 1.0 decimal | 17 participants |
| Day 120-180 | Uncorrected Decimal VA (5 m) | Binocular worse than 0.5 decimal | 0 participants |
| Day 120-180 | Uncorrected Decimal VA (5 m) | Binocular 0.5 to less than 0.7 decimal | 0 participants |
| Day 120-180 | Uncorrected Decimal VA (5 m) | Second Eye 0.5 to less than 0.7 decimal | 6 participants |
| Day 330-420 | Uncorrected Decimal VA (5 m) | Binocular 0.5 to less than 0.7 decimal | 1 participants |
| Day 330-420 | Uncorrected Decimal VA (5 m) | Binocular worse than 0.5 decimal | 0 participants |
| Day 330-420 | Uncorrected Decimal VA (5 m) | Second Eye 1.0 decimal or better | 38 participants |
| Day 330-420 | Uncorrected Decimal VA (5 m) | First Eye 1.0 decimal or better | 44 participants |
| Day 330-420 | Uncorrected Decimal VA (5 m) | Binocular 1.0 decimal or better | 55 participants |
| Day 330-420 | Uncorrected Decimal VA (5 m) | First Eye 0.7 to less than1.0 decimal | 13 participants |
| Day 330-420 | Uncorrected Decimal VA (5 m) | Second Eye worse than 0.5 decimal | 0 participants |
| Day 330-420 | Uncorrected Decimal VA (5 m) | First Eye 0.5 to less than 0.7 decimal | 6 participants |
| Day 330-420 | Uncorrected Decimal VA (5 m) | First Eye worse than 0.5 decimal | 0 participants |
| Day 330-420 | Uncorrected Decimal VA (5 m) | Binocular 0.7 to less than 1.0 decimal | 7 participants |
| Day 330-420 | Uncorrected Decimal VA (5 m) | Second Eye 0.7 to less than 1.0 decimal | 22 participants |
| Day 330-420 | Uncorrected Decimal VA (5 m) | Second Eye 0.5 to less than 0.7 decimal | 3 participants |
Secondary
Best Corrected Far (3 m) Contrast Sensitivity
Far contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 3 m using the Vector Vision CSV 1000 illuminated box (one site) and the Vision Contrast Test System (other site). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). For CSV 1000, contrast sensitivity was not measured at spatial frequency 1.5 cpd because there was no option for this frequency. Raw scores were transformed to logMar (logarithm of the minimum angle of resolution) units. A higher numeric value represents better contrast sensitivity.
Time frame: Day 120-180 from second eye implantation
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preoperative | Best Corrected Far (3 m) Contrast Sensitivity | 3 cpd | 1.889 logMAR | Standard Deviation 0.13 |
| Preoperative | Best Corrected Far (3 m) Contrast Sensitivity | 12 cpd | 1.673 logMAR | Standard Deviation 0.186 |
| Preoperative | Best Corrected Far (3 m) Contrast Sensitivity | 6 cpd | 2.026 logMAR | Standard Deviation 0.138 |
| Preoperative | Best Corrected Far (3 m) Contrast Sensitivity | 18 cpd | 1.176 logMAR | Standard Deviation 0.223 |
| Preoperative | Best Corrected Far (3 m) Contrast Sensitivity | 1.5 cpd | NA logMAR | — |
| Day 1-2 | Best Corrected Far (3 m) Contrast Sensitivity | 18 cpd | 1.356 logMAR | Standard Deviation 0.244 |
| Day 1-2 | Best Corrected Far (3 m) Contrast Sensitivity | 1.5 cpd | 1.760 logMAR | Standard Deviation 0.227 |
| Day 1-2 | Best Corrected Far (3 m) Contrast Sensitivity | 3 cpd | 2.047 logMAR | Standard Deviation 0.2 |
| Day 1-2 | Best Corrected Far (3 m) Contrast Sensitivity | 6 cpd | 2.080 logMAR | Standard Deviation 0.187 |
| Day 1-2 | Best Corrected Far (3 m) Contrast Sensitivity | 12 cpd | 1.800 logMAR | Standard Deviation 0.273 |
Secondary
Best Corrected Near (46 cm) Contrast Sensitivity
Near contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 46 cm using the Functional Acuity Contrast Test (FACT). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). Raw scores were transformed to logMar units. A higher numeric value represents better contrast sensitivity.
Time frame: Day 120-180 from second eye implantation
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preoperative | Best Corrected Near (46 cm) Contrast Sensitivity | 1.5 cpd | 1.825 logMAR | Standard Deviation 0.121 |
| Preoperative | Best Corrected Near (46 cm) Contrast Sensitivity | 3 cpd | 1.933 logMAR | Standard Deviation 0.137 |
| Preoperative | Best Corrected Near (46 cm) Contrast Sensitivity | 6 cpd | 1.739 logMAR | Standard Deviation 0.192 |
| Preoperative | Best Corrected Near (46 cm) Contrast Sensitivity | 12 cpd | 1.311 logMAR | Standard Deviation 0.22 |
| Preoperative | Best Corrected Near (46 cm) Contrast Sensitivity | 18 cpd | 0.856 logMAR | Standard Deviation 0.22 |
Secondary
Distance Corrected Decimal VA (1 m)
VA was tested binocularly using a chart. Distance-corrected VA at 1 m is the VA at 1 m measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time frame: Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative | Distance Corrected Decimal VA (1 m) | Worse than 0.5 decimal | 3 participants |
| Preoperative | Distance Corrected Decimal VA (1 m) | 0.5 to less than 0.7 decimal | 4 participants |
| Preoperative | Distance Corrected Decimal VA (1 m) | 0.7 to less than 1.0 decimal | 24 participants |
| Preoperative | Distance Corrected Decimal VA (1 m) | 1.0 decimal or better | 33 participants |
| Day 1-2 | Distance Corrected Decimal VA (1 m) | 1.0 decimal or better | 34 participants |
| Day 1-2 | Distance Corrected Decimal VA (1 m) | Worse than 0.5 decimal | 0 participants |
| Day 1-2 | Distance Corrected Decimal VA (1 m) | 0.7 to less than 1.0 decimal | 26 participants |
| Day 1-2 | Distance Corrected Decimal VA (1 m) | 0.5 to less than 0.7 decimal | 3 participants |
Secondary
Distance Corrected Decimal VA (40 cm)
VA was tested binocularly using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time frame: Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative | Distance Corrected Decimal VA (40 cm) | 0.4 decimal or better | 62 participants |
| Preoperative | Distance Corrected Decimal VA (40 cm) | Worse than 0.4 decimal | 2 participants |
| Day 1-2 | Distance Corrected Decimal VA (40 cm) | Worse than 0.4 decimal | 2 participants |
| Day 1-2 | Distance Corrected Decimal VA (40 cm) | 0.4 decimal or better | 61 participants |
Secondary
Mean Best Distance (cm) for Distance Corrected Decimal Near VA
VA was tested monocularly at Day 1-2, Day 7-14, Day 30-60, Day 120-180, and Day 330-420 and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction using a chart. The participant indicated the distance (cm) at which best near vision was attained.
Time frame: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preoperative | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | First Eye | 48.2 centimeters | Standard Deviation 4.5 |
| Preoperative | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | Binocular | NA centimeters | — |
| Preoperative | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | Second Eye | 48.2 centimeters | Standard Deviation 4.3 |
| Day 1-2 | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | First Eye | 49.5 centimeters | Standard Deviation 4.4 |
| Day 1-2 | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | Binocular | NA centimeters | — |
| Day 1-2 | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | Second Eye | 48.3 centimeters | Standard Deviation 3.5 |
| Day 7-14 | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | First Eye | 48.6 centimeters | Standard Deviation 3.9 |
| Day 7-14 | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | Binocular | 48.8 centimeters | Standard Deviation 3.9 |
| Day 7-14 | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | Second Eye | 48.5 centimeters | Standard Deviation 3.6 |
| Day 30-60 | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | Binocular | 48.8 centimeters | Standard Deviation 3.1 |
| Day 30-60 | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | Second Eye | 49.0 centimeters | Standard Deviation 3.3 |
| Day 30-60 | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | First Eye | 49.1 centimeters | Standard Deviation 3.3 |
| Day 120-180 | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | First Eye | 49.4 centimeters | Standard Deviation 3.2 |
| Day 120-180 | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | Binocular | 49.5 centimeters | Standard Deviation 3.1 |
| Day 120-180 | Mean Best Distance (cm) for Distance Corrected Decimal Near VA | Second Eye | 49.2 centimeters | Standard Deviation 3.5 |
Secondary
Mean Best Distance (cm) for Uncorrected Decimal Near VA
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided using a chart. The participant indicated the distance (cm) at which best near vision was attained.
Time frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects. Here, n is the number of participants with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preoperative | Mean Best Distance (cm) for Uncorrected Decimal Near VA | Second Eye (n=47,64,64,64,64,63) | 39.8 centimeters | Standard Deviation 12 |
| Preoperative | Mean Best Distance (cm) for Uncorrected Decimal Near VA | First Eye (n=45,64,64,64,64,63) | 40.5 centimeters | Standard Deviation 11.6 |
| Preoperative | Mean Best Distance (cm) for Uncorrected Decimal Near VA | Binocular (n=NA,NA,NA,64,64,63) | NA centimeters | — |
| Day 1-2 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | First Eye (n=45,64,64,64,64,63) | 46.9 centimeters | Standard Deviation 5.2 |
| Day 1-2 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | Second Eye (n=47,64,64,64,64,63) | 47.1 centimeters | Standard Deviation 3.8 |
| Day 1-2 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | Binocular (n=NA,NA,NA,64,64,63) | NA centimeters | — |
| Day 7-14 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | Binocular (n=NA,NA,NA,64,64,63) | NA centimeters | — |
| Day 7-14 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | First Eye (n=45,64,64,64,64,63) | 47.3 centimeters | Standard Deviation 4.4 |
| Day 7-14 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | Second Eye (n=47,64,64,64,64,63) | 46.9 centimeters | Standard Deviation 4 |
| Day 30-60 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | Second Eye (n=47,64,64,64,64,63) | 46.9 centimeters | Standard Deviation 3.7 |
| Day 30-60 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | First Eye (n=45,64,64,64,64,63) | 47.2 centimeters | Standard Deviation 3.8 |
| Day 30-60 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | Binocular (n=NA,NA,NA,64,64,63) | 47.0 centimeters | Standard Deviation 3.9 |
| Day 120-180 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | Second Eye (n=47,64,64,64,64,63) | 47.5 centimeters | Standard Deviation 3.9 |
| Day 120-180 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | Binocular (n=NA,NA,NA,64,64,63) | 47.8 centimeters | Standard Deviation 3.6 |
| Day 120-180 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | First Eye (n=45,64,64,64,64,63) | 47.3 centimeters | Standard Deviation 3.6 |
| Day 330-420 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | First Eye (n=45,64,64,64,64,63) | 48.5 centimeters | Standard Deviation 3.6 |
| Day 330-420 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | Binocular (n=NA,NA,NA,64,64,63) | 48.9 centimeters | Standard Deviation 3.3 |
| Day 330-420 | Mean Best Distance (cm) for Uncorrected Decimal Near VA | Second Eye (n=47,64,64,64,64,63) | 48.5 centimeters | Standard Deviation 3.7 |
Secondary
Mean Defocus Decimal VA (5 m)
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction at a distance of 5 m using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time frame: Day 120-180 from second eye implantation
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Preoperative | Mean Defocus Decimal VA (5 m) | -0.50 | 1.16 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | -1.00 | 0.93 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | -1.50 | 0.84 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | -2.00 | 0.94 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | -2.50 | 0.73 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | -3.00 | 0.51 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | -3.50 | 0.36 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | -4.00 | 0.25 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | -4.50 | 0.19 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | +2.00 | 0.44 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | +1.50 | 0.65 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | +1.00 | 0.85 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | +0.50 | 1.11 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | 0.00 | 1.43 decimal |
| Preoperative | Mean Defocus Decimal VA (5 m) | -5.00 | 0.14 decimal |
Secondary
Percentage of Participants With Positive Response, Quality of Life Questions
The participant completed a questionnaire, indicating (yes/no) if he/she experienced visual difficulty in every-day activities while not wearing spectacles. A positive response was defined as, Yes=visual difficulty.
Time frame: Day 120-180 from second eye implantation
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Reading small print, labels, telephone book | 89.1 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Reading a newspaper or a book | 81.3 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Reading dial plate of a wrist watch | 10.9 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Reading headline in a newspaper or book | 7.8 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Writing on papers or documents | 60.9 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Playing games such as chess, cards, mah-jongg | 1.6 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Drawing, sewing, knitting, or handiwork | 51.6 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Cooking | 15.6 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Watching TV | 3.1 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Seeing steps or stairs | 3.1 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Reading dial plate of clock or numbers on calendar | 3.1 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Recognizing people when they are close | 1.6 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Reading a timetable in subway or train station | 6.3 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Reading plate of a bus or train coming | 1.6 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Reading traffic sign or shop sign | 1.6 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Seeing a PC screen | 42.2 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Seeing face in the mirror during makeup or shaving | 18.8 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Seeing distant blackboard or slide | 39.1 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Quality of Life Questions | Play table tennis, gate ball, tennis, golf, bowl | 4.7 percentage of participants |
Secondary
Percentage of Participants With Positive Response, Stereoscopic Vision Test
Stereopsis (the ability to perceive depth and 3-dimensional structure) was assessed binocularly under well-lit conditions at best distance using the Stereo Optical Company, Inc., Original Stereo Fly Test and polarized viewers. The participant was shown a series of symbols, with a positive response defined as correct identification of the 3-dimensional symbol. Responses were recorded for 3 symbols: Fly (easiest to perceive), animal, and circle (hardest to perceive).
Time frame: Day 120-180 from second eye implantation
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative | Percentage of Participants With Positive Response, Stereoscopic Vision Test | House Fly | 100.0 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Stereoscopic Vision Test | Animal | 93.8 percentage of participants |
| Preoperative | Percentage of Participants With Positive Response, Stereoscopic Vision Test | Circle | 85.9 percentage of participants |
Secondary
Uncorrected Decimal VA (1 m)
VA was tested binocularly unaided at a distance of 1 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time frame: Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative | Uncorrected Decimal VA (1 m) | Worse than 0.5 decimal | 0 participants |
| Preoperative | Uncorrected Decimal VA (1 m) | 0.5 to less than 0.7 decimal | 8 participants |
| Preoperative | Uncorrected Decimal VA (1 m) | 0.7 to less than 1.0 decimal | 20 participants |
| Preoperative | Uncorrected Decimal VA (1 m) | 1.0 decimal or better | 36 participants |
| Day 1-2 | Uncorrected Decimal VA (1 m) | 1.0 decimal or better | 38 participants |
| Day 1-2 | Uncorrected Decimal VA (1 m) | Worse than 0.5 decimal | 0 participants |
| Day 1-2 | Uncorrected Decimal VA (1 m) | 0.7 to less than 1.0 decimal | 22 participants |
| Day 1-2 | Uncorrected Decimal VA (1 m) | 0.5 to less than 0.7 decimal | 3 participants |
Secondary
Uncorrected Decimal VA (40 cm)
VA was tested binocularly unaided at a distance of 40 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time frame: Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative | Uncorrected Decimal VA (40 cm) | Worse than 0.4 decimal | 3 participants |
| Preoperative | Uncorrected Decimal VA (40 cm) | 0.4 decimal or better | 61 participants |
| Day 1-2 | Uncorrected Decimal VA (40 cm) | Worse than 0.4 decimal | 2 participants |
| Day 1-2 | Uncorrected Decimal VA (40 cm) | 0.4 decimal or better | 61 participants |
Secondary
Uncorrected Decimal VA at Best Distance
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart at the distance of best near vision (cm) as decided by the participant. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative | Uncorrected Decimal VA at Best Distance | Second Eye worse than 0.4 decimal | 48 participants |
| Preoperative | Uncorrected Decimal VA at Best Distance | Binocular worse than 0.4 decimal | NA participants |
| Preoperative | Uncorrected Decimal VA at Best Distance | Binocular 0.4 decimal or better | NA participants |
| Preoperative | Uncorrected Decimal VA at Best Distance | First Eye worse than 0.4 decimal | 52 participants |
| Preoperative | Uncorrected Decimal VA at Best Distance | Second Eye 0.4 decimal or better | 16 participants |
| Preoperative | Uncorrected Decimal VA at Best Distance | First Eye 0.4 decimal or better | 12 participants |
| Day 1-2 | Uncorrected Decimal VA at Best Distance | Second Eye worse than 0.4 decimal | 14 participants |
| Day 1-2 | Uncorrected Decimal VA at Best Distance | Second Eye 0.4 decimal or better | 50 participants |
| Day 1-2 | Uncorrected Decimal VA at Best Distance | First Eye 0.4 decimal or better | 51 participants |
| Day 1-2 | Uncorrected Decimal VA at Best Distance | Binocular worse than 0.4 decimal | NA participants |
| Day 1-2 | Uncorrected Decimal VA at Best Distance | Binocular 0.4 decimal or better | NA participants |
| Day 1-2 | Uncorrected Decimal VA at Best Distance | First Eye worse than 0.4 decimal | 13 participants |
| Day 7-14 | Uncorrected Decimal VA at Best Distance | Binocular 0.4 decimal or better | NA participants |
| Day 7-14 | Uncorrected Decimal VA at Best Distance | Binocular worse than 0.4 decimal | NA participants |
| Day 7-14 | Uncorrected Decimal VA at Best Distance | Second Eye worse than 0.4 decimal | 6 participants |
| Day 7-14 | Uncorrected Decimal VA at Best Distance | First Eye worse than 0.4 decimal | 6 participants |
| Day 7-14 | Uncorrected Decimal VA at Best Distance | First Eye 0.4 decimal or better | 58 participants |
| Day 7-14 | Uncorrected Decimal VA at Best Distance | Second Eye 0.4 decimal or better | 58 participants |
| Day 30-60 | Uncorrected Decimal VA at Best Distance | Binocular 0.4 decimal or better | 62 participants |
| Day 30-60 | Uncorrected Decimal VA at Best Distance | Binocular worse than 0.4 decimal | 2 participants |
| Day 30-60 | Uncorrected Decimal VA at Best Distance | First Eye worse than 0.4 decimal | 4 participants |
| Day 30-60 | Uncorrected Decimal VA at Best Distance | First Eye 0.4 decimal or better | 60 participants |
| Day 30-60 | Uncorrected Decimal VA at Best Distance | Second Eye worse than 0.4 decimal | 4 participants |
| Day 30-60 | Uncorrected Decimal VA at Best Distance | Second Eye 0.4 decimal or better | 60 participants |
| Day 120-180 | Uncorrected Decimal VA at Best Distance | Second Eye worse than 0.4 decimal | 3 participants |
| Day 120-180 | Uncorrected Decimal VA at Best Distance | Second Eye 0.4 decimal or better | 61 participants |
| Day 120-180 | Uncorrected Decimal VA at Best Distance | Binocular 0.4 decimal or better | 62 participants |
| Day 120-180 | Uncorrected Decimal VA at Best Distance | Binocular worse than 0.4 decimal | 2 participants |
| Day 120-180 | Uncorrected Decimal VA at Best Distance | First Eye 0.4 decimal or better | 59 participants |
| Day 120-180 | Uncorrected Decimal VA at Best Distance | First Eye worse than 0.4 decimal | 5 participants |
| Day 330-420 | Uncorrected Decimal VA at Best Distance | First Eye worse than 0.4 decimal | 3 participants |
| Day 330-420 | Uncorrected Decimal VA at Best Distance | Second Eye 0.4 decimal or better | 58 participants |
| Day 330-420 | Uncorrected Decimal VA at Best Distance | Second Eye worse than 0.4 decimal | 5 participants |
| Day 330-420 | Uncorrected Decimal VA at Best Distance | Binocular 0.4 decimal or better | 62 participants |
| Day 330-420 | Uncorrected Decimal VA at Best Distance | First Eye 0.4 decimal or better | 60 participants |
| Day 330-420 | Uncorrected Decimal VA at Best Distance | Binocular worse than 0.4 decimal | 1 participants |