Cataract
Conditions
Keywords
Intra Ocular Lens, Ocular surgery, Phacoemulsification
Brief summary
The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.
Interventions
DEVICECrystalens AO
Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
DEVICEReSTOR
ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
DEVICETecnis Multifocal IOL
Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction. * Subjects must require a spherical lens power from 10.00 D to 33.00 D * Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter
Exclusion criteria
* Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens. * Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis. * Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree | Postoperative visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | Postoperative visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | Postoperative visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | Postoperative visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree | Postoperative visit 4 ( 4-6 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree | Postoperative visit 4 ( 4-6 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Optical Scatter | Visit 3 (2-3 months) | Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention. |
| Monocular Halo and Starburst | Visit 3 (2-3 months) | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. |
| Binocular Halo and Starburst | Visit 3 (2-3 months) | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. |
| Manifest Refraction | Visit 3 (2-3 Months) | Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder. |
| Uncorrected Distance Visual Acuity | Visit 3 (2-3 months) Visit 4 (4-6 months) | High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches |
| Best-corrected Distance Visual Acuity | Visit 3 (2-3 months) Visit 4 (4-6 months) | High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA) |
| Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | Visit 4 (4-6 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | Visit 3 (2-3 months) | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
Countries
United States
Participant flow
Recruitment details
This study took place at two investigative sites in the United States, with the first participant undergoing cataract surgery on 5/18/2010 and last participant completed the study on 6/27/2012.
Pre-assignment details
Seventy eight participants (156 eyes) were enrolled in the study. 148 eyes were analyzed in both the full analysis set and the per protocol set.
Participants by arm
| Arm | Count |
|---|---|
| Crystalens AO Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days. | 26 |
| ReSTOR Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days. | 26 |
| Tecnis Multifocal IOL Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days. | 26 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Post-Cataract Surgery | Central Macular Edema | 0 | 0 | 1 |
| Post-Cataract Surgery | Fellow Eye Explanted | 0 | 0 | 1 |
| Pre-Cataract Surgery | Withdrawal by Subject | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Crystalens AO | ReSTOR | Tecnis Multifocal IOL |
|---|---|---|---|---|
| Age, Customized 40 - 49 years | 2 participants | 0 participants | 1 participants | 1 participants |
| Age, Customized <40 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized 50-59 years | 23 participants | 10 participants | 5 participants | 8 participants |
| Age, Customized 60-69 years | 37 participants | 13 participants | 12 participants | 12 participants |
| Age, Customized 70-79 years | 15 participants | 3 participants | 8 participants | 4 participants |
| Age, Customized ≥ 80 | 1 participants | 0 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 78 participants | 26 participants | 26 participants | 26 participants |
| Sex: Female, Male Female | 51 Participants | 17 Participants | 15 Participants | 19 Participants |
| Sex: Female, Male Male | 27 Participants | 9 Participants | 11 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 52 | 13 / 50 | 4 / 46 |
| serious Total, serious adverse events | 0 / 26 | 1 / 25 | 3 / 23 |
Outcome results
Primary
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 4 ( 4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | 1.229 log contrast sensitivity units | Standard Deviation 0.262 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | 1.218 log contrast sensitivity units | Standard Deviation 0.238 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | 1.217 log contrast sensitivity units | Standard Deviation 0.275 |
Primary
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | 1.155 log contrast sensitivity units | Standard Deviation 0.238 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | 1.335 log contrast sensitivity units | Standard Deviation 0.309 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | 1.143 log contrast sensitivity units | Standard Deviation 0.189 |
Primary
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree | 1.5 cycles/degree | 1.494 log contrast sensitivity units | Standard Deviation 0.173 |
| Crystalens AO | Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree | 3 cycles/degree | 1.613 log contrast sensitivity units | Standard Deviation 0.171 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree | 1.5 cycles/degree | 1.576 log contrast sensitivity units | Standard Deviation 0.209 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree | 3 cycles/degree | 1.679 log contrast sensitivity units | Standard Deviation 0.199 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree | 1.5 cycles/degree | 1.410 log contrast sensitivity units | Standard Deviation 0.195 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree | 3 cycles/degree | 1.528 log contrast sensitivity units | Standard Deviation 0.175 |
Primary
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 4 ( 4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree | 1.525 log contrast sensitivity units | Standard Deviation 0.203 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree | 1.588 log contrast sensitivity units | Standard Deviation 0.213 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree | 1.408 log contrast sensitivity units | Standard Deviation 0.172 |
Primary
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 4 ( 4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | 0.998 log contrast sensitivity units | Standard Deviation 0.297 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | 0.789 log contrast sensitivity units | Standard Deviation 0.219 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | 0.896 log contrast sensitivity units | Standard Deviation 0.275 |
Primary
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | 0.943 log contrast sensitivity units | Standard Deviation 0.266 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | 0.950 log contrast sensitivity units | Standard Deviation 0.297 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | 0.697 log contrast sensitivity units | Standard Deviation 0.138 |
Primary
Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 4 ( 4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree | 1.638 log contrast sensitivity units | Standard Deviation 0.243 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree | 1.698 log contrast sensitivity units | Standard Deviation 0.221 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree | 1.519 log contrast sensitivity units | Standard Deviation 0.125 |
Primary
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 4 ( 4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | 1.610 log contrast sensitivity units | Standard Deviation 0.241 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | 1.622 log contrast sensitivity units | Standard Deviation 0.228 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | 1.543 log contrast sensitivity units | Standard Deviation 0.261 |
Primary
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | 1.563 log contrast sensitivity units | Standard Deviation 0.228 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | 1.644 log contrast sensitivity units | Standard Deviation 0.253 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | 1.481 log contrast sensitivity units | Standard Deviation 0.212 |
Secondary
Best-corrected Distance Visual Acuity
High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)
Time frame: Visit 3 (2-3 months) Visit 4 (4-6 months)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Best-corrected Distance Visual Acuity | BCDVA Monocular Visit 3 | -0.100 logMAR | Standard Deviation 0.07 |
| Crystalens AO | Best-corrected Distance Visual Acuity | BCDVA Monocular Visit 4 | -0.100 logMAR | Standard Deviation 0.066 |
| Crystalens AO | Best-corrected Distance Visual Acuity | BCDVA Binocular Visit 3 | -0.144 logMAR | Standard Deviation 0.049 |
| Crystalens AO | Best-corrected Distance Visual Acuity | BCDVA Binocular Visit 4 | -0.136 logMAR | Standard Deviation 0.049 |
| Crystalens AO | Best-corrected Distance Visual Acuity | DCIVA Monocular Visit 3 | 0.169 logMAR | Standard Deviation 0.144 |
| Crystalens AO | Best-corrected Distance Visual Acuity | DCIVA Monocular Visit 4 | 0.186 logMAR | Standard Deviation 0.129 |
| Crystalens AO | Best-corrected Distance Visual Acuity | DCIVA Binocular Visit 3 | 0.095 logMAR | Standard Deviation 0.146 |
| Crystalens AO | Best-corrected Distance Visual Acuity | DCIVA Binocular Visit 4 | 0.084 logMAR | Standard Deviation 0.109 |
| Crystalens AO | Best-corrected Distance Visual Acuity | DCNVA Monocular Visit 3 | 0.346 logMAR | Standard Deviation 0.13 |
| Crystalens AO | Best-corrected Distance Visual Acuity | DCNVA Monocular Visit 4 | 0.360 logMAR | Standard Deviation 0.144 |
| Crystalens AO | Best-corrected Distance Visual Acuity | DCNVA Binocular Visit 3 | 0.261 logMAR | Standard Deviation 0.109 |
| Crystalens AO | Best-corrected Distance Visual Acuity | DCNVA Binocular Visit 4 | 0.247 logMAR | Standard Deviation 0.126 |
| ReSTOR | Best-corrected Distance Visual Acuity | DCNVA Binocular Visit 4 | -0.075 logMAR | Standard Deviation 0.096 |
| ReSTOR | Best-corrected Distance Visual Acuity | BCDVA Monocular Visit 3 | -0.094 logMAR | Standard Deviation 0.08 |
| ReSTOR | Best-corrected Distance Visual Acuity | DCIVA Binocular Visit 3 | 0.222 logMAR | Standard Deviation 0.112 |
| ReSTOR | Best-corrected Distance Visual Acuity | DCNVA Monocular Visit 3 | -0.004 logMAR | Standard Deviation 0.087 |
| ReSTOR | Best-corrected Distance Visual Acuity | BCDVA Monocular Visit 4 | -0.096 logMAR | Standard Deviation 0.106 |
| ReSTOR | Best-corrected Distance Visual Acuity | DCIVA Monocular Visit 4 | 0.297 logMAR | Standard Deviation 0.119 |
| ReSTOR | Best-corrected Distance Visual Acuity | DCNVA Binocular Visit 3 | -0.079 logMAR | Standard Deviation 0.065 |
| ReSTOR | Best-corrected Distance Visual Acuity | BCDVA Binocular Visit 3 | -0.133 logMAR | Standard Deviation 0.073 |
| ReSTOR | Best-corrected Distance Visual Acuity | DCIVA Binocular Visit 4 | 0.229 logMAR | Standard Deviation 0.108 |
| ReSTOR | Best-corrected Distance Visual Acuity | DCIVA Monocular Visit 3 | 0.292 logMAR | Standard Deviation 0.132 |
| ReSTOR | Best-corrected Distance Visual Acuity | BCDVA Binocular Visit 4 | -0.137 logMAR | Standard Deviation 0.058 |
| ReSTOR | Best-corrected Distance Visual Acuity | DCNVA Monocular Visit 4 | -0.042 logMAR | Standard Deviation 0.132 |
| Tecnis Multifocal IOL | Best-corrected Distance Visual Acuity | BCDVA Binocular Visit 4 | -0.117 logMAR | Standard Deviation 0.098 |
| Tecnis Multifocal IOL | Best-corrected Distance Visual Acuity | DCIVA Monocular Visit 3 | 0.292 logMAR | Standard Deviation 0.162 |
| Tecnis Multifocal IOL | Best-corrected Distance Visual Acuity | DCNVA Monocular Visit 4 | 0.136 logMAR | Standard Deviation 0.144 |
| Tecnis Multifocal IOL | Best-corrected Distance Visual Acuity | DCIVA Monocular Visit 4 | 0.328 logMAR | Standard Deviation 0.159 |
| Tecnis Multifocal IOL | Best-corrected Distance Visual Acuity | DCIVA Binocular Visit 3 | 0.196 logMAR | Standard Deviation 0.112 |
| Tecnis Multifocal IOL | Best-corrected Distance Visual Acuity | DCIVA Binocular Visit 4 | 0.229 logMAR | Standard Deviation 0.127 |
| Tecnis Multifocal IOL | Best-corrected Distance Visual Acuity | DCNVA Binocular Visit 3 | -0.004 logMAR | Standard Deviation 0.1 |
| Tecnis Multifocal IOL | Best-corrected Distance Visual Acuity | BCDVA Monocular Visit 3 | -0.068 logMAR | Standard Deviation 0.098 |
| Tecnis Multifocal IOL | Best-corrected Distance Visual Acuity | BCDVA Monocular Visit 4 | -0.075 logMAR | Standard Deviation 0.088 |
| Tecnis Multifocal IOL | Best-corrected Distance Visual Acuity | DCNVA Monocular Visit 3 | 0.132 logMAR | Standard Deviation 0.143 |
| Tecnis Multifocal IOL | Best-corrected Distance Visual Acuity | BCDVA Binocular Visit 3 | 0.115 logMAR | Standard Deviation 0.057 |
| Tecnis Multifocal IOL | Best-corrected Distance Visual Acuity | DCNVA Binocular Visit 4 | 0.025 logMAR | Standard Deviation 0.127 |
Secondary
Binocular Halo and Starburst
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Time frame: Visit 3 (2-3 months)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Binocular Halo and Starburst | Halo | 1.2 units on a scale | Standard Deviation 1.1 |
| Crystalens AO | Binocular Halo and Starburst | Starburst | 4.6 units on a scale | Standard Deviation 1.1 |
| ReSTOR | Binocular Halo and Starburst | Halo | 1.4 units on a scale | Standard Deviation 0.8 |
| ReSTOR | Binocular Halo and Starburst | Starburst | 4.7 units on a scale | Standard Deviation 1 |
| Tecnis Multifocal IOL | Binocular Halo and Starburst | Halo | 2.0 units on a scale | Standard Deviation 1 |
| Tecnis Multifocal IOL | Binocular Halo and Starburst | Starburst | 4.6 units on a scale | Standard Deviation 0.9 |
Secondary
Binocular Halo and Starburst
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Time frame: Visit 4 (4-6 months)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Binocular Halo and Starburst | Halo | 1.3 units on a scale | Standard Deviation 0.7 |
| Crystalens AO | Binocular Halo and Starburst | Starburst | 4.6 units on a scale | Standard Deviation 1 |
| ReSTOR | Binocular Halo and Starburst | Halo | 1.8 units on a scale | Standard Deviation 1.2 |
| ReSTOR | Binocular Halo and Starburst | Starburst | 4.9 units on a scale | Standard Deviation 0.4 |
| Tecnis Multifocal IOL | Binocular Halo and Starburst | Halo | 2.0 units on a scale | Standard Deviation 0.9 |
| Tecnis Multifocal IOL | Binocular Halo and Starburst | Starburst | 4.5 units on a scale | Standard Deviation 0.9 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | 1.261 log contrast sensitivity units | Standard Deviation 0.291 |
| ReSTOR | Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | 1.273 log contrast sensitivity units | Standard Deviation 0.269 |
| Tecnis Multifocal IOL | Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | 1.235 log contrast sensitivity units | Standard Deviation 0.245 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | 1.189 log contrast sensitivity units | Standard Deviation 0.17 |
| ReSTOR | Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | 1.362 log contrast sensitivity units | Standard Deviation 0.323 |
| Tecnis Multifocal IOL | Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | 1.153 log contrast sensitivity units | Standard Deviation 0.228 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | 3 cycles/degree | 1.785 log contrast sensitivity units | Standard Deviation 0.223 |
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | 1.5 cycles/degree | 1.712 log contrast sensitivity units | Standard Deviation 0.212 |
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | 6 cycles/degree | 1.710 log contrast sensitivity units | Standard Deviation 0.234 |
| ReSTOR | Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | 3 cycles/degree | 1.768 log contrast sensitivity units | Standard Deviation 0.243 |
| ReSTOR | Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | 1.5 cycles/degree | 1.743 log contrast sensitivity units | Standard Deviation 0.218 |
| ReSTOR | Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | 6 cycles/degree | 1.682 log contrast sensitivity units | Standard Deviation 0.268 |
| Tecnis Multifocal IOL | Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | 1.5 cycles/degree | 1.537 log contrast sensitivity units | Standard Deviation 0.147 |
| Tecnis Multifocal IOL | Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | 6 cycles/degree | 1.595 log contrast sensitivity units | Standard Deviation 0.265 |
| Tecnis Multifocal IOL | Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | 3 cycles/degree | 1.594 log contrast sensitivity units | Standard Deviation 0.135 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full set analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree | 3 cycles/degree | 1.775 log contrast sensitivity units | Standard Deviation 0.252 |
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree | 1.5 cycles/degree | 1.688 log contrast sensitivity units | Standard Deviation 0.221 |
| ReSTOR | Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree | 1.5 cycles/degree | 1.749 log contrast sensitivity units | Standard Deviation 0.201 |
| ReSTOR | Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree | 3 cycles/degree | 1.797 log contrast sensitivity units | Standard Deviation 0.213 |
| Tecnis Multifocal IOL | Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree | 1.5 cycles/degree | 1.537 log contrast sensitivity units | Standard Deviation 0.129 |
| Tecnis Multifocal IOL | Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree | 3 cycles/degree | 1.667 log contrast sensitivity units | Standard Deviation 0.168 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | 1.160 log contrast sensitivity units | Standard Deviation 0.356 |
| ReSTOR | Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | 1.008 log contrast sensitivity units | Standard Deviation 0.386 |
| Tecnis Multifocal IOL | Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | 0.885 log contrast sensitivity units | Standard Deviation 0.287 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | 0.965 log contrast sensitivity units | Standard Deviation 0.258 |
| ReSTOR | Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | 0.994 log contrast sensitivity units | Standard Deviation 0.359 |
| Tecnis Multifocal IOL | Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | 0.861 log contrast sensitivity units | Standard Deviation 0.241 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree | 1.731 log contrast sensitivity units | Standard Deviation 0.213 |
| ReSTOR | Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree | 1.677 log contrast sensitivity units | Standard Deviation 0.257 |
| Tecnis Multifocal IOL | Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree | 1.593 log contrast sensitivity units | Standard Deviation 0.225 |
Secondary
Manifest Refraction
Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Time frame: Visit 3 (2-3 Months)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Manifest Refraction | -0.507 Diopters | Standard Deviation 0.433 |
| ReSTOR | Manifest Refraction | 0.038 Diopters | Standard Deviation 0.344 |
| Tecnis Multifocal IOL | Manifest Refraction | -0.114 Diopters | Standard Deviation 0.362 |
Secondary
Manifest Refraction
Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Time frame: Visit 4 (4-6 Months)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Manifest Refraction | -0.339 Diopters | Standard Deviation 0.455 |
| ReSTOR | Manifest Refraction | 0.145 Diopters | Standard Deviation 0.37 |
| Tecnis Multifocal IOL | Manifest Refraction | -0.091 Diopters | Standard Deviation 0.339 |
Secondary
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | 1.199 log contrast sensitivity units | Standard Deviation 0.243 |
| ReSTOR | Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | 1.337 log contrast sensitivity units | Standard Deviation 0.273 |
| Tecnis Multifocal IOL | Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | 1.141 log contrast sensitivity units | Standard Deviation 0.222 |
Secondary
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | 1.321 log contrast sensitivity units | Standard Deviation 0.331 |
| ReSTOR | Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | 1.319 log contrast sensitivity units | Standard Deviation 0.45 |
| Tecnis Multifocal IOL | Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | 1.337 log contrast sensitivity units | Standard Deviation 0.419 |
Secondary
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | 1.5 cycles/degree | 1.392 log contrast sensitivity units | Standard Deviation 0.222 |
| Crystalens AO | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | 3 cycles/degree | 1.573 log contrast sensitivity units | Standard Deviation 0.268 |
| ReSTOR | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | 1.5 cycles/degree | 1.404 log contrast sensitivity units | Standard Deviation 0.238 |
| ReSTOR | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | 3 cycles/degree | 1.493 log contrast sensitivity units | Standard Deviation 0.304 |
| Tecnis Multifocal IOL | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | 1.5 cycles/degree | 1.344 log contrast sensitivity units | Standard Deviation 0.151 |
| Tecnis Multifocal IOL | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | 3 cycles/degree | 1.410 log contrast sensitivity units | Standard Deviation 0.223 |
Secondary
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | 1.5 cycles/degree | 1.459 log contrast sensitivity units | Standard Deviation 0.239 |
| Crystalens AO | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | 3 cycles/degree | 1.609 log contrast sensitivity units | Standard Deviation 0.189 |
| ReSTOR | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | 1.5 cycles/degree | 1.439 log contrast sensitivity units | Standard Deviation 0.216 |
| ReSTOR | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | 3 cycles/degree | 1.492 log contrast sensitivity units | Standard Deviation 0.264 |
| Tecnis Multifocal IOL | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | 1.5 cycles/degree | 1.316 log contrast sensitivity units | Standard Deviation 0.21 |
| Tecnis Multifocal IOL | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | 3 cycles/degree | 1.405 log contrast sensitivity units | Standard Deviation 0.225 |
Secondary
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | 1.175 log contrast sensitivity units | Standard Deviation 0.258 |
| ReSTOR | Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | 1.101 log contrast sensitivity units | Standard Deviation 0.439 |
| Tecnis Multifocal IOL | Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | 1.060 log contrast sensitivity units | Standard Deviation 0.648 |
Secondary
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | 0.980 log contrast sensitivity units | Standard Deviation 0.295 |
| ReSTOR | Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | 1.009 log contrast sensitivity units | Standard Deviation 0.096 |
| Tecnis Multifocal IOL | Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | 0.690 log contrast sensitivity units | Standard Deviation 0.125 |
Secondary
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | 1.574 log contrast sensitivity units | Standard Deviation 0.183 |
| ReSTOR | Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | 1.496 log contrast sensitivity units | Standard Deviation 0.385 |
| Tecnis Multifocal IOL | Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | 1.412 log contrast sensitivity units | Standard Deviation 0.261 |
Secondary
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | 1.519 log contrast sensitivity units | Standard Deviation 0.296 |
| ReSTOR | Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | 1.515 log contrast sensitivity units | Standard Deviation 0.33 |
| Tecnis Multifocal IOL | Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | 1.448 log contrast sensitivity units | Standard Deviation 0.271 |
Secondary
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | 1.118 log contrast sensitivity units | Standard Deviation 0.225 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | 1.192 log contrast sensitivity units | Standard Deviation 0.235 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | 1.059 log contrast sensitivity units | Standard Deviation 0.208 |
Secondary
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | 1.341 log contrast sensitivity units | Standard Deviation 0.341 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | 1.272 log contrast sensitivity units | Standard Deviation 0.358 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | 1.190 log contrast sensitivity units | Standard Deviation 0.327 |
Secondary
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | 1.343 log contrast sensitivity units | Standard Deviation 0.254 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | 1.367 log contrast sensitivity units | Standard Deviation 0.229 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | 1.199 log contrast sensitivity units | Standard Deviation 0.145 |
Secondary
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | 1.329 log contrast sensitivity units | Standard Deviation 0.172 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | 1.389 log contrast sensitivity units | Standard Deviation 0.219 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | 1.233 log contrast sensitivity units | Standard Deviation 0.182 |
Secondary
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | 1.139 log contrast sensitivity units | Standard Deviation 0.315 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | 1.192 log contrast sensitivity units | Standard Deviation 0.334 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | 0.849 log contrast sensitivity units | Standard Deviation 0.353 |
Secondary
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | 0.883 log contrast sensitivity units | Standard Deviation 0.199 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | 0.989 log contrast sensitivity units | Standard Deviation 0.336 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | 0.903 log contrast sensitivity units | Standard Deviation 0 |
Secondary
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | 1.536 log contrast sensitivity units | Standard Deviation 0.247 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | 1.462 log contrast sensitivity units | Standard Deviation 0.212 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | 1.367 log contrast sensitivity units | Standard Deviation 0.196 |
Secondary
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | 1.527 log contrast sensitivity units | Standard Deviation 0.19 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | 1.518 log contrast sensitivity units | Standard Deviation 0.267 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | 1.388 log contrast sensitivity units | Standard Deviation 0.245 |
Secondary
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | 1.514 log contrast sensitivity units | Standard Deviation 0.217 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | 1.504 log contrast sensitivity units | Standard Deviation 0.313 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | 1.397 log contrast sensitivity units | Standard Deviation 0.265 |
Secondary
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | 1.535 log contrast sensitivity units | Standard Deviation 0.274 |
| ReSTOR | Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | 1.475 log contrast sensitivity units | Standard Deviation 0.276 |
| Tecnis Multifocal IOL | Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | 1.413 log contrast sensitivity units | Standard Deviation 0.265 |
Secondary
Monocular Halo and Starburst
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Time frame: Visit 3 (2-3 months)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Monocular Halo and Starburst | Halo | 1.2 units on a scale | Standard Deviation 0.9 |
| Crystalens AO | Monocular Halo and Starburst | Starburst | 4.5 units on a scale | Standard Deviation 1.1 |
| ReSTOR | Monocular Halo and Starburst | Halo | 1.3 units on a scale | Standard Deviation 0.8 |
| ReSTOR | Monocular Halo and Starburst | Starburst | 4.7 units on a scale | Standard Deviation 1 |
| Tecnis Multifocal IOL | Monocular Halo and Starburst | Starburst | 4.5 units on a scale | Standard Deviation 1.2 |
| Tecnis Multifocal IOL | Monocular Halo and Starburst | Halo | 1.8 units on a scale | Standard Deviation 0.9 |
Secondary
Monocular Halo and Starburst
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Time frame: Visit 4 (4-6 months)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Monocular Halo and Starburst | Halo | 1.2 units on a scale | Standard Deviation 0.6 |
| Crystalens AO | Monocular Halo and Starburst | Starburst | 4.6 units on a scale | Standard Deviation 1 |
| ReSTOR | Monocular Halo and Starburst | Starburst | 4.7 units on a scale | Standard Deviation 1 |
| ReSTOR | Monocular Halo and Starburst | Halo | 1.5 units on a scale | Standard Deviation 0.8 |
| Tecnis Multifocal IOL | Monocular Halo and Starburst | Starburst | 4.5 units on a scale | Standard Deviation 1.2 |
| Tecnis Multifocal IOL | Monocular Halo and Starburst | Halo | 1.8 units on a scale | Standard Deviation 0.7 |
Secondary
Optical Scatter
Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.
Time frame: Visit 3 (2-3 months)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Optical Scatter | 1.1280 units on a scale | Standard Deviation 0.7661 |
| ReSTOR | Optical Scatter | 1.8080 units on a scale | Standard Deviation 0.8685 |
| Tecnis Multifocal IOL | Optical Scatter | 1.9179 units on a scale | Standard Deviation 0.9751 |
Secondary
Optical Scatter
Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.
Time frame: Visit 4 (4-6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Optical Scatter | 1.1308 units on a scale | Standard Deviation 0.7337 |
| ReSTOR | Optical Scatter | 1.9760 units on a scale | Standard Deviation 1.163 |
| Tecnis Multifocal IOL | Optical Scatter | 1.8318 units on a scale | Standard Deviation 0.984 |
Secondary
Uncorrected Distance Visual Acuity
High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches
Time frame: Visit 3 (2-3 months) Visit 4 (4-6 months)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Uncorrected Distance Visual Acuity | UCDVA Monocular Visit 3 | 0.122 logMAR | Standard Deviation 0.171 |
| Crystalens AO | Uncorrected Distance Visual Acuity | UCDVA Monocular Visit 4 | 0.113 logMAR | Standard Deviation 0.173 |
| Crystalens AO | Uncorrected Distance Visual Acuity | UCDVA Binocular Visit 3 | 0.005 logMAR | Standard Deviation 0.082 |
| Crystalens AO | Uncorrected Distance Visual Acuity | UCDVA Binocular Visit 4 | -0.026 logMAR | Standard Deviation 0.11 |
| Crystalens AO | Uncorrected Distance Visual Acuity | UCIVA Monocular Visit 3 | 0.055 logMAR | Standard Deviation 0.159 |
| Crystalens AO | Uncorrected Distance Visual Acuity | UCIVA Monocular Visit 4 | 0.066 logMAR | Standard Deviation 0.168 |
| Crystalens AO | Uncorrected Distance Visual Acuity | UCIVA Binocular Visit 3 | -0.012 logMAR | Standard Deviation 0.13 |
| Crystalens AO | Uncorrected Distance Visual Acuity | UCIVA Binocular Visit 4 | -0.024 logMAR | Standard Deviation 0.111 |
| Crystalens AO | Uncorrected Distance Visual Acuity | UCNVA Monocular Visit 3 | 0.192 logMAR | Standard Deviation 0.189 |
| Crystalens AO | Uncorrected Distance Visual Acuity | UCNVA Monocular Visit 4 | 0.264 logMAR | Standard Deviation 0.195 |
| Crystalens AO | Uncorrected Distance Visual Acuity | UCNVA Binocular Visit 3 | 0.082 logMAR | Standard Deviation 0.151 |
| Crystalens AO | Uncorrected Distance Visual Acuity | UCNVA Binocular Visit 4 | 0.133 logMAR | Standard Deviation 0.148 |
| ReSTOR | Uncorrected Distance Visual Acuity | UCNVA Binocular Visit 4 | -0.061 logMAR | Standard Deviation 0.087 |
| ReSTOR | Uncorrected Distance Visual Acuity | UCDVA Monocular Visit 3 | 0.002 logMAR | Standard Deviation 0.115 |
| ReSTOR | Uncorrected Distance Visual Acuity | UCIVA Binocular Visit 3 | 0.138 logMAR | Standard Deviation 0.14 |
| ReSTOR | Uncorrected Distance Visual Acuity | UCNVA Monocular Visit 3 | 0.005 logMAR | Standard Deviation 0.108 |
| ReSTOR | Uncorrected Distance Visual Acuity | UCDVA Monocular Visit 4 | 0.016 logMAR | Standard Deviation 0.121 |
| ReSTOR | Uncorrected Distance Visual Acuity | UCIVA Monocular Visit 4 | 0.244 logMAR | Standard Deviation 0.158 |
| ReSTOR | Uncorrected Distance Visual Acuity | UCNVA Binocular Visit 3 | -0.057 logMAR | Standard Deviation 0.074 |
| ReSTOR | Uncorrected Distance Visual Acuity | UCDVA Binocular Visit 3 | -0.054 logMAR | Standard Deviation 0.102 |
| ReSTOR | Uncorrected Distance Visual Acuity | UCIVA Binocular Visit 4 | 0.169 logMAR | Standard Deviation 0.144 |
| ReSTOR | Uncorrected Distance Visual Acuity | UCIVA Monocular Visit 3 | 0.219 logMAR | Standard Deviation 0.15 |
| ReSTOR | Uncorrected Distance Visual Acuity | UCDVA Binocular Visit 4 | -0.061 logMAR | Standard Deviation 0.08 |
| ReSTOR | Uncorrected Distance Visual Acuity | UCNVA Monocular Visit 4 | -0.008 logMAR | Standard Deviation 0.12 |
| Tecnis Multifocal IOL | Uncorrected Distance Visual Acuity | UCDVA Binocular Visit 4 | -0.053 logMAR | Standard Deviation 0.104 |
| Tecnis Multifocal IOL | Uncorrected Distance Visual Acuity | UCIVA Monocular Visit 3 | 0.237 logMAR | Standard Deviation 0.221 |
| Tecnis Multifocal IOL | Uncorrected Distance Visual Acuity | UCNVA Monocular Visit 4 | 0.188 logMAR | Standard Deviation 0.185 |
| Tecnis Multifocal IOL | Uncorrected Distance Visual Acuity | UCIVA Monocular Visit 4 | 0.237 logMAR | Standard Deviation 0.197 |
| Tecnis Multifocal IOL | Uncorrected Distance Visual Acuity | UCIVA Binocular Visit 3 | 0.126 logMAR | Standard Deviation 0.169 |
| Tecnis Multifocal IOL | Uncorrected Distance Visual Acuity | UCIVA Binocular Visit 4 | 0.175 logMAR | Standard Deviation 0.146 |
| Tecnis Multifocal IOL | Uncorrected Distance Visual Acuity | UCNVA Binocular Visit 3 | 0.041 logMAR | Standard Deviation 0.109 |
| Tecnis Multifocal IOL | Uncorrected Distance Visual Acuity | UCDVA Monocular Visit 3 | 0.072 logMAR | Standard Deviation 0.15 |
| Tecnis Multifocal IOL | Uncorrected Distance Visual Acuity | UCDVA Monocular Visit 4 | 0.060 logMAR | Standard Deviation 0.148 |
| Tecnis Multifocal IOL | Uncorrected Distance Visual Acuity | UCNVA Monocular Visit 3 | 0.164 logMAR | Standard Deviation 0.149 |
| Tecnis Multifocal IOL | Uncorrected Distance Visual Acuity | UCDVA Binocular Visit 3 | -0.048 logMAR | Standard Deviation 0.087 |
| Tecnis Multifocal IOL | Uncorrected Distance Visual Acuity | UCNVA Binocular Visit 4 | 0.043 logMAR | Standard Deviation 0.13 |