Cataracts
Conditions
Brief summary
The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.
Detailed description
Subjects will attend a total of 9 visits (6 postoperative) over a 7 month period.
Interventions
Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
DEVICEAT LISA® tri IOL
Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of bilateral cataracts with planned clear cornea cataract removal; * Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures; * Calculated lens power between 13.0 and 30.0 Diopters (D); * Preoperative Best-corrected distance visual acuity (BCDVA) worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in at least one eye; * Potential postoperative BCDVA of 0.20 logMAR or better in both eyes. Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial; * Preoperative regular corneal astigmatism of \< 1.00 D, in both eyes; * Clear intraocular media other than cataract in both eyes; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Reasonably expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy); * Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions); * Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema; * Amblyopia; * Previous corneal transplant; * Any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction; * Rubella, congenital, traumatic, or complicated cataracts; * Glaucoma (uncontrolled or controlled with medication); * Degenerative eye disorders; * History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy; * Optic nerve atrophy; * Expected to require retinal laser treatment; * Color vision deficiencies; * Pregnant or lactating (current or planned during the course of the study); * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180 | Day 120-180 from second eye implantation | VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180 | Day 120-180 from second eye implantation | VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. |
| Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180 | Day 120-180 from second eye implantation | VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. |
| Mean Photopic Binocular Defocus Curve at Day 120-180 | Day 120-180 from second eye implantation | A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed. |
| Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Day 120-180 from second eye implantation | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. |
| Least Squares Mean Binocular UCIVA (60cm) at Day 120-180 | Day 120-180 from second eye implantation | VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. |
| Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Day 120-180 from second eye implantation | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. |
| Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Day 120-180 from second eye implantation | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. |
| Subject Satisfaction Recorded at Day 120-180 | Day 120-180 from second eye implantation | At the Month 6 Visit, subjects responded to the question: Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?. Responses were reported as a percentage of subjects. No statistical test was performed. |
| Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Day 120-180 from second eye implantation | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. |
Participant flow
Recruitment details
Subjects were recruited from 15 study centers located in Australia (3), Brazil (3), Spain (3), Denmark (2), Colombia (2), United Kingdom (1), and the Netherlands (1).
Pre-assignment details
Of the 215 enrolled, 26 subjects were exited as screen failures and 1 subject died prior to randomization. This reporting group includes all randomized subjects (188).
Participants by arm
| Arm | Count |
|---|---|
| TFNT00 AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation | 93 |
| 839MP AT LISA® tri IOL, bilateral implantation | 89 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | TFNT00 | 839MP | Total |
|---|---|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 9.29 | 65.6 years STANDARD_DEVIATION 9.56 | 65.9 years STANDARD_DEVIATION 9.4 |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Native American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 3 Participants | 8 Participants | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Multi-Racial | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 44 Participants | 38 Participants | 82 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White or Caucasian | 42 Participants | 39 Participants | 81 Participants |
| Sex: Female, Male Female | 57 Participants | 55 Participants | 112 Participants |
| Sex: Female, Male Male | 36 Participants | 34 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 93 | 0 / 93 | 0 / 93 | 0 / 89 | 0 / 87 | 0 / 2 | 0 / 89 |
| other Total, other adverse events | 8 / 93 | 8 / 93 | 0 / 93 | 7 / 89 | 3 / 87 | 0 / 2 | 0 / 89 |
| serious Total, serious adverse events | 0 / 93 | 0 / 93 | 2 / 93 | 3 / 89 | 2 / 87 | 0 / 2 | 0 / 89 |
Outcome results
Primary
Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180
VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Time frame: Day 120-180 from second eye implantation
Population: All-Implanted Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TFNT00 | Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180 | 0.053 logMAR | Standard Error 0.0134 |
| 839MP | Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180 | 0.115 logMAR | Standard Error 0.0139 |
90% CI: [-0.093, -0.029]
Secondary
Least Squares Mean Binocular UCIVA (60cm) at Day 120-180
VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Time frame: Day 120-180 from second eye implantation
Population: All-Implanted Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TFNT00 | Least Squares Mean Binocular UCIVA (60cm) at Day 120-180 | 0.053 logMAR | Standard Error 0.0134 |
| 839MP | Least Squares Mean Binocular UCIVA (60cm) at Day 120-180 | 0.115 logMAR | Standard Error 0.0139 |
p-value: 0.00290% CI: [-0.093, -0.029]Repeated Measures Analysis of Variance
Secondary
Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180
VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Time frame: Day 120-180 from second eye implantation
Population: All-Implanted Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TFNT00 | Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180 | 0.015 logMAR | Standard Error 0.0109 |
| 839MP | Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180 | 0.004 logMAR | Standard Error 0.0113 |
95% CI: [-0.019, 0.043]
p-value: 0.455Repeated Measures Analysis of Variance
Secondary
Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180
VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Time frame: Day 120-180 from second eye implantation
Population: All-Implanted Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TFNT00 | Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180 | 0.083 logMAR | Standard Error 0.0116 |
| 839MP | Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180 | 0.133 logMAR | Standard Error 0.0121 |
90% CI: [-0.078, -0.023]
p-value: 0.003Repeated Measures Analysis of Variance
Secondary
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
Time frame: Day 120-180 from second eye implantation
Population: Best-Case Analysis Set, with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 1.5 CPD | 1.579 log units | Standard Deviation 0.2581 |
| TFNT00 | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 3 CPD | 1.642 log units | Standard Deviation 0.2696 |
| TFNT00 | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 6 CPD | 1.550 log units | Standard Deviation 0.4791 |
| TFNT00 | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 12 CPD | 1.146 log units | Standard Deviation 0.5623 |
| 839MP | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 12 CPD | 1.175 log units | Standard Deviation 0.6062 |
| 839MP | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 1.5 CPD | 1.538 log units | Standard Deviation 0.2568 |
| 839MP | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 6 CPD | 1.607 log units | Standard Deviation 0.4898 |
| 839MP | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 3 CPD | 1.682 log units | Standard Deviation 0.2642 |
Secondary
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
Time frame: Day 120-180 from second eye implantation
Population: Best-Case Analysis Set with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 1.5 CPD | 1.611 log units | Standard Deviation 0.2293 |
| TFNT00 | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 3 CPD | 1.648 log units | Standard Deviation 0.3115 |
| TFNT00 | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 6 CPD | 1.667 log units | Standard Deviation 0.4284 |
| TFNT00 | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 12 CPD | 1.208 log units | Standard Deviation 0.5262 |
| 839MP | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 12 CPD | 1.227 log units | Standard Deviation 0.5307 |
| 839MP | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 1.5 CPD | 1.600 log units | Standard Deviation 0.2226 |
| 839MP | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 6 CPD | 1.676 log units | Standard Deviation 0.4243 |
| 839MP | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 3 CPD | 1.682 log units | Standard Deviation 0.2639 |
Secondary
Mean Photopic Binocular Defocus Curve at Day 120-180
A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed.
Time frame: Day 120-180 from second eye implantation
Population: This analysis population includes all subjects with eyes successfully implanted with the test or control article that had at least one postoperative visit, and with no macular degeneration at any time, and no major protocol deviations (Best-Case Analysis Set), with data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Mean Photopic Binocular Defocus Curve at Day 120-180 | -1.5D | 0.038 logMAR | Standard Deviation 0.0983 |
| TFNT00 | Mean Photopic Binocular Defocus Curve at Day 120-180 | -3.0D | 0.118 logMAR | Standard Deviation 0.1297 |
| TFNT00 | Mean Photopic Binocular Defocus Curve at Day 120-180 | -1.0D | 0.093 logMAR | Standard Deviation 0.0993 |
| TFNT00 | Mean Photopic Binocular Defocus Curve at Day 120-180 | -3.5D | 0.231 logMAR | Standard Deviation 0.1252 |
| TFNT00 | Mean Photopic Binocular Defocus Curve at Day 120-180 | -2.0D | 0.011 logMAR | Standard Deviation 0.0859 |
| TFNT00 | Mean Photopic Binocular Defocus Curve at Day 120-180 | -4.0D | 0.338 logMAR | Standard Deviation 0.1319 |
| TFNT00 | Mean Photopic Binocular Defocus Curve at Day 120-180 | -0.5D | 0.016 logMAR | Standard Deviation 0.0835 |
| TFNT00 | Mean Photopic Binocular Defocus Curve at Day 120-180 | -4.5D | 0.469 logMAR | Standard Deviation 0.1417 |
| TFNT00 | Mean Photopic Binocular Defocus Curve at Day 120-180 | -2.5D | 0.027 logMAR | Standard Deviation 0.1013 |
| TFNT00 | Mean Photopic Binocular Defocus Curve at Day 120-180 | -5.0D | 0.586 logMAR | Standard Deviation 0.1292 |
| TFNT00 | Mean Photopic Binocular Defocus Curve at Day 120-180 | 0.0 Diopter (D) | -0.048 logMAR | Standard Deviation 0.0811 |
| 839MP | Mean Photopic Binocular Defocus Curve at Day 120-180 | -5.0D | 0.644 logMAR | Standard Deviation 0.1048 |
| 839MP | Mean Photopic Binocular Defocus Curve at Day 120-180 | 0.0 Diopter (D) | -0.069 logMAR | Standard Deviation 0.0831 |
| 839MP | Mean Photopic Binocular Defocus Curve at Day 120-180 | -0.5D | -0.018 logMAR | Standard Deviation 0.0951 |
| 839MP | Mean Photopic Binocular Defocus Curve at Day 120-180 | -1.0D | 0.048 logMAR | Standard Deviation 0.1207 |
| 839MP | Mean Photopic Binocular Defocus Curve at Day 120-180 | -1.5D | 0.084 logMAR | Standard Deviation 0.1111 |
| 839MP | Mean Photopic Binocular Defocus Curve at Day 120-180 | -2.0D | 0.117 logMAR | Standard Deviation 0.1039 |
| 839MP | Mean Photopic Binocular Defocus Curve at Day 120-180 | -2.5D | 0.063 logMAR | Standard Deviation 0.1399 |
| 839MP | Mean Photopic Binocular Defocus Curve at Day 120-180 | -3.0D | 0.077 logMAR | Standard Deviation 0.1241 |
| 839MP | Mean Photopic Binocular Defocus Curve at Day 120-180 | -3.5D | 0.206 logMAR | Standard Deviation 0.1415 |
| 839MP | Mean Photopic Binocular Defocus Curve at Day 120-180 | -4.0D | 0.364 logMAR | Standard Deviation 0.1302 |
| 839MP | Mean Photopic Binocular Defocus Curve at Day 120-180 | -4.5D | 0.532 logMAR | Standard Deviation 0.124 |
Secondary
Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
Time frame: Day 120-180 from second eye implantation
Population: Best-Case Analysis Set, with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 3 CPD | 1.721 log units | Standard Deviation 0.2041 |
| TFNT00 | Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 6 CPD | 1.790 log units | Standard Deviation 0.3282 |
| TFNT00 | Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 12 CPD | 1.434 log units | Standard Deviation 0.4616 |
| TFNT00 | Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 18 CPD | 1.007 log units | Standard Deviation 0.3769 |
| 839MP | Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 18 CPD | 1.033 log units | Standard Deviation 0.4316 |
| 839MP | Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 3 CPD | 1.754 log units | Standard Deviation 0.2225 |
| 839MP | Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 12 CPD | 1.426 log units | Standard Deviation 0.457 |
| 839MP | Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 6 CPD | 1.797 log units | Standard Deviation 0.3538 |
Secondary
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
Time frame: Day 120-180 from second eye implantation
Population: Best-Case Analysis Set, with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 3 CPD | 1.720 log units | Standard Deviation 0.2025 |
| TFNT00 | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 6 CPD | 1.860 log units | Standard Deviation 0.2635 |
| TFNT00 | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 12 CPD | 1.482 log units | Standard Deviation 0.3853 |
| TFNT00 | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 18 CPD | 1.021 log units | Standard Deviation 0.3778 |
| 839MP | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 18 CPD | 1.022 log units | Standard Deviation 0.4197 |
| 839MP | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 3 CPD | 1.735 log units | Standard Deviation 0.1894 |
| 839MP | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 12 CPD | 1.496 log units | Standard Deviation 0.4328 |
| 839MP | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | 6 CPD | 1.831 log units | Standard Deviation 0.2699 |
Secondary
Subject Satisfaction Recorded at Day 120-180
At the Month 6 Visit, subjects responded to the question: Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?. Responses were reported as a percentage of subjects. No statistical test was performed.
Time frame: Day 120-180 from second eye implantation
Population: All-Implanted Analysis Set with data available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TFNT00 | Subject Satisfaction Recorded at Day 120-180 | Yes | 95.7 percentage of subjects |
| TFNT00 | Subject Satisfaction Recorded at Day 120-180 | No | 3.2 percentage of subjects |
| TFNT00 | Subject Satisfaction Recorded at Day 120-180 | Missing | 1.1 percentage of subjects |
| 839MP | Subject Satisfaction Recorded at Day 120-180 | Yes | 96.6 percentage of subjects |
| 839MP | Subject Satisfaction Recorded at Day 120-180 | No | 2.3 percentage of subjects |
| 839MP | Subject Satisfaction Recorded at Day 120-180 | Missing | 1.1 percentage of subjects |