Cataract
Conditions
Keywords
phacoemulsification, intraocular lens
Brief summary
The objective of this study is to compare the contrast sensitivity, high and low contrast visual acuity (VA), glare meter outcomes, and subject satisfaction with three different FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near vision following lens extraction in adults at least 40 years of age.
Interventions
DEVICECrystalens AO
Bausch & Lomb model silicone multi-piece accommodating IOL.
DEVICEReSTOR 3.0
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
DEVICEAMO Tecnis Multifocal
The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.
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 be undergoing primary IOL implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction. * Subjects must require a spherical lens power from 10.00 diopters (D) to 33.00 D. * Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes. * Subjects must have stopped contact lens wear for at least two weeks for soft lens wearers or three weeks for gas permeable lens wearers prior to biometry and surgery. * At the time of surgery, subjects must have an intact centered capsulorhexis, intact posterior capsule, and no zonular rupture. * Subjects must have ≤ 1.25 D of preoperative corneal astigmatism in both eyes.
Exclusion criteria
* Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level of 20/32 or worse. * Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. * 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 uncontrolled glaucoma. * Subjects with previous retinal detachment. * Subjects with visually significant diabetic retinopathy (proliferative or nonproliferative) which reduces potential acuity to 20/32 or worse. * Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract. * Subjects with marked microphthalmos or aniridia. * Subjects who have had previous corneal surgery. * Subjects with irregular corneal astigmatism. * Subjects with amblyopia which reduces potential acuity to 20/32 or worse. * Subjects with optic atrophy. * Subjects with iris neovascularization. * Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/32 or worse. * Subjects with chronic use of systemic steroids or immunosuppressive medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) | Postoperative visit 3 (day 30-60) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | Postoperative visit 3 (day 30-60) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | Postoperative visit 3 (day 30-60) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | Postoperative visit 3 (day 30-60) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | Postoperative visit 4 (day 120-180) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree) | Postoperative visit 3 (day 30-60) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | Postoperative visit 3 (day 30-60) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | Postoperative visit 3 (day 30-60) | In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | Postoperative visit 3 (day 30-60) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree) | Postoperative visit 4 (day 120-180) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | Postoperative visit 3 (day 30-60) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | Postoperative visit 3 (day 30-60) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | Postoperative visit 3 (day 30-60) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | Postoperative visit 3 (day 30-60) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | Postoperative visit 3 (day 30-60) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
Countries
Philippines
Participant flow
Recruitment details
This study was an evaluation of three United States Food and Drug Administration (FDA) approved IOLs. A total of 93 participants(186 eyes) were enrolled at one investigative site in the Philippines. First participant was enrolled 7/15/2010 and last participant exited the study 4/28/2011.
Pre-assignment details
186 participant eyes were enrolled in this study 154 participant eyes completed the study. Participants underwent bilateral phacoemulsification and IOL implantation. Participants were randomized to treatment groups prior to surgery.
Participants by arm
| Arm | Count |
|---|---|
| Crystalens AO Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens | 31 |
| ReSTOR 3.0 An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. | 31 |
| AMO Tecnis Multifocal A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL | 31 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Study Eye Explanted | 0 | 0 | 1 |
| Overall Study | Surgical complications | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 4 | 5 |
Baseline characteristics
| Characteristic | Total | Crystalens AO | ReSTOR 3.0 | AMO Tecnis Multifocal |
|---|---|---|---|---|
| Age, Customized 40 - 49 years | 3 participants | 2 participants | 1 participants | 0 participants |
| Age, Customized < 40 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized 50 - 59 years | 21 participants | 6 participants | 8 participants | 7 participants |
| Age, Customized 60 - 69 years | 43 participants | 13 participants | 14 participants | 16 participants |
| Age, Customized 70 - 79 years | 25 participants | 10 participants | 8 participants | 7 participants |
| Age, Customized >/= 80 years | 1 participants | 0 participants | 0 participants | 1 participants |
| Region of Enrollment Philippines | 93 participants | 31 participants | 31 participants | 31 participants |
| Sex: Female, Male Female | 70 Participants | 23 Participants | 25 Participants | 22 Participants |
| Sex: Female, Male Male | 23 Participants | 8 Participants | 6 Participants | 9 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 | 12 / 53 | 5 / 54 | 6 / 51 |
| serious Total, serious adverse events | 0 / 53 | 0 / 54 | 0 / 51 |
Outcome results
Primary
Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | 1.280 log contrast sensitivity units | Standard Deviation 0.245 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | 1.225 log contrast sensitivity units | Standard Deviation 0.253 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | 1.230 log contrast sensitivity units | Standard Deviation 0.248 |
Primary
Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full Analysis Set, non-missing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | 1.325 log contrast sensitivity units | Standard Deviation 0.226 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | 1.227 log contrast sensitivity units | Standard Deviation 0.198 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | 1.324 log contrast sensitivity units | Standard Deviation 0.281 |
Primary
Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)
A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) | 1.5 cycles/degree | 1.612 log contrast sensitivity units | Standard Deviation 0.229 |
| Crystalens AO | Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) | 3 cycles/degree | 1.658 log contrast sensitivity units | Standard Deviation 0.195 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) | 1.5 cycles/degree | 1.582 log contrast sensitivity units | Standard Deviation 0.231 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) | 3 cycles/degree | 1.627 log contrast sensitivity units | Standard Deviation 0.224 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) | 1.5 cycles/degree | 1.527 log contrast sensitivity units | Standard Deviation 0.248 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) | 3 cycles/degree | 1.629 log contrast sensitivity units | Standard Deviation 0.24 |
Primary
Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 1.5 cycles/degree | 1.696 log contrast sensitivity units | Standard Deviation 0.213 |
| Crystalens AO | Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 3 cycles/degree | 1.678 log contrast sensitivity units | Standard Deviation 0.159 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 1.5 cycles/degree | 1.621 log contrast sensitivity units | Standard Deviation 0.222 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 3 cycles/degree | 1.670 log contrast sensitivity units | Standard Deviation 0.236 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 1.5 cycles/degree | 1.527 log contrast sensitivity units | Standard Deviation 0.19 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 3 cycles/degree | 1.630 log contrast sensitivity units | Standard Deviation 0.203 |
Primary
Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | 0.974 log contrast sensitivity units | Standard Deviation 0.303 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | 0.980 log contrast sensitivity units | Standard Deviation 0.246 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | 0.976 log contrast sensitivity units | Standard Deviation 0.207 |
Primary
Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full Analysis Set, non-missing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | 0.977 log contrast sensitivity units | Standard Deviation 0.266 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | 0.985 log contrast sensitivity units | Standard Deviation 0.185 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | 0.973 log contrast sensitivity units | Standard Deviation 0.342 |
Primary
Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | 1.579 log contrast sensitivity units | Standard Deviation 0.239 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | 1.499 log contrast sensitivity units | Standard Deviation 0.23 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | 1.610 log contrast sensitivity units | Standard Deviation 0.228 |
Primary
Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full Analysis Set, non-missing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | 1.641 log contrast sensitivity units | Standard Deviation 0.21 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | 1.611 log contrast sensitivity units | Standard Deviation 0.237 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | 1.641 log contrast sensitivity units | Standard Deviation 0.286 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | 1.371 log contrast sensitivity units | Standard Deviation 0.247 |
| ReSTOR 3.0 | Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | 1.269 log contrast sensitivity units | Standard Deviation 0.257 |
| AMO Tecnis Multifocal | Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | 1.310 log contrast sensitivity units | Standard Deviation 0.286 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | 1.425 log contrast sensitivity units | Standard Deviation 0.221 |
| ReSTOR 3.0 | Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | 1.335 log contrast sensitivity units | Standard Deviation 0.218 |
| AMO Tecnis Multifocal | Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | 1.361 log contrast sensitivity units | Standard Deviation 0.278 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 1.5 cycles/degree | 1.770 log contrast sensitivity units | Standard Deviation 0.187 |
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 3 cycles/degree | 1.807 log contrast sensitivity units | Standard Deviation 0.199 |
| ReSTOR 3.0 | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 1.5 cycles/degree | 1.656 log contrast sensitivity units | Standard Deviation 0.238 |
| ReSTOR 3.0 | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 3 cycles/degree | 1.679 log contrast sensitivity units | Standard Deviation 0.275 |
| AMO Tecnis Multifocal | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 1.5 cycles/degree | 1.605 log contrast sensitivity units | Standard Deviation 0.203 |
| AMO Tecnis Multifocal | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 3 cycles/degree | 1.689 log contrast sensitivity units | Standard Deviation 0.189 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 1.5 cycles/degree | 1.797 log contrast sensitivity units | Standard Deviation 0.183 |
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 3 cycles/degree | 1.851 log contrast sensitivity units | Standard Deviation 0.178 |
| ReSTOR 3.0 | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 1.5 cycles/degree | 1.751 log contrast sensitivity units | Standard Deviation 0.238 |
| ReSTOR 3.0 | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 3 cycles/degree | 1.723 log contrast sensitivity units | Standard Deviation 0.239 |
| AMO Tecnis Multifocal | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 1.5 cycles/degree | 1.577 log contrast sensitivity units | Standard Deviation 0.206 |
| AMO Tecnis Multifocal | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | 3 cycles/degree | 1.702 log contrast sensitivity units | Standard Deviation 0.219 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | 1.029 log contrast sensitivity units | Standard Deviation 0.25 |
| ReSTOR 3.0 | Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | 1.001 log contrast sensitivity units | Standard Deviation 0.213 |
| AMO Tecnis Multifocal | Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | 0.981 log contrast sensitivity units | Standard Deviation 0.362 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | 1.115 log contrast sensitivity units | Standard Deviation 0.299 |
| ReSTOR 3.0 | Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | 0.995 log contrast sensitivity units | Standard Deviation 0.384 |
| AMO Tecnis Multifocal | Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | 1.041 log contrast sensitivity units | Standard Deviation 0.33 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | 1.758 log contrast sensitivity units | Standard Deviation 0.28 |
| ReSTOR 3.0 | Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | 1.640 log contrast sensitivity units | Standard Deviation 0.236 |
| AMO Tecnis Multifocal | Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | 1.690 log contrast sensitivity units | Standard Deviation 0.263 |
Secondary
Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | 1.825 log contrast sensitivity units | Standard Deviation 0.216 |
| ReSTOR 3.0 | Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | 1.591 log contrast sensitivity units | Standard Deviation 0.274 |
| AMO Tecnis Multifocal | Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | 1.700 log contrast sensitivity units | Standard Deviation 0.284 |
Secondary
Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | 1.328 log contrast sensitivity units | Standard Deviation 0.224 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | 1.230 log contrast sensitivity units | Standard Deviation 0.223 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | 1.340 log contrast sensitivity units | Standard Deviation 0.268 |
Secondary
Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | 1.335 log contrast sensitivity units | Standard Deviation 0.298 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | 1.246 log contrast sensitivity units | Standard Deviation 0.278 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | 1.194 log contrast sensitivity units | Standard Deviation 0.237 |
Secondary
Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | 1.591 log contrast sensitivity units | Standard Deviation 0.215 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | 1.519 log contrast sensitivity units | Standard Deviation 0.218 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | 1.482 log contrast sensitivity units | Standard Deviation 0.268 |
Secondary
Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | 1.550 log contrast sensitivity units | Standard Deviation 0.263 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | 1.488 log contrast sensitivity units | Standard Deviation 0.226 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | 1.449 log contrast sensitivity units | Standard Deviation 0.206 |
Secondary
Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | 1.024 log contrast sensitivity units | Standard Deviation 0.196 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | 0.945 log contrast sensitivity units | Standard Deviation 0.158 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | 0.834 log contrast sensitivity units | Standard Deviation 0.283 |
Secondary
Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | 0.919 log contrast sensitivity units | Standard Deviation 0.283 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | 1.019 log contrast sensitivity units | Standard Deviation 0.367 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | 0.935 log contrast sensitivity units | Standard Deviation 0.207 |
Secondary
Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)
In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree) | 1.687 log contrast sensitivity units | Standard Deviation 0.229 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree) | 1.581 log contrast sensitivity units | Standard Deviation 0.204 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree) | 1.588 log contrast sensitivity units | Standard Deviation 0.264 |
Secondary
Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)
In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree) | 1.664 log contrast sensitivity units | Standard Deviation 0.258 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree) | 1.572 log contrast sensitivity units | Standard Deviation 0.225 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree) | 1.535 log contrast sensitivity units | Standard Deviation 0.22 |
Secondary
Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 4 (day 120-180)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | 1.578 log contrast sensitivity units | Standard Deviation 0.252 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | 1.493 log contrast sensitivity units | Standard Deviation 0.267 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | 1.519 log contrast sensitivity units | Standard Deviation 0.26 |
Secondary
Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time frame: Postoperative visit 3 (day 30-60)
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystalens AO | Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | 1.674 log contrast sensitivity units | Standard Deviation 0.237 |
| ReSTOR 3.0 | Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | 1.531 log contrast sensitivity units | Standard Deviation 0.238 |
| AMO Tecnis Multifocal | Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | 1.626 log contrast sensitivity units | Standard Deviation 0.293 |