Phase 4
N=93
Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT01225952 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) — 1.612; 1.582; 1.527; 1.658 log contrast sensitivity units
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Crystalens AO (Device); ReSTOR 3.0 (Device); AMO Tecnis Multifocal (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) |
1.612; 1.582; 1.527; 1.658; 1.627; 1.629 | — |
| PRIMARY Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) |
1.579; 1.499; 1.610 | — |
| PRIMARY Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) |
1.280; 1.225; 1.230 | — |
| PRIMARY Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) |
0.974; 0.980; 0.976 | — |
| PRIMARY Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) |
1.696; 1.621; 1.527; 1.678; 1.670; 1.630 | — |
| PRIMARY Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) |
1.579; 1.499; 1.610 | — |
| PRIMARY Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) |
1.280; 1.225; 1.230 | — |
| PRIMARY Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) |
0.974; 0.980; 0.976 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) |
1.797; 1.751; 1.577; 1.851; 1.723; 1.702 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) |
1.758; 1.640; 1.690 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) |
1.371; 1.269; 1.310 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) |
1.115; 0.995; 1.041 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) |
1.797; 1.751; 1.577; 1.851; 1.723; 1.702 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) |
1.758; 1.640; 1.690 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) |
1.371; 1.269; 1.310 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) |
1.115; 0.995; 1.041 | — |
| SECONDARY Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) |
1.550; 1.488; 1.449 | — |
| SECONDARY Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree) |
1.687; 1.581; 1.588 | — |
| SECONDARY Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) |
1.578; 1.493; 1.519 | — |
| SECONDARY Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) |
1.335; 1.246; 1.194 | — |
| SECONDARY Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) |
0.919; 1.019; 0.935 | — |
| SECONDARY Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) |
1.550; 1.488; 1.449 | — |
| SECONDARY Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree) |
1.664; 1.572; 1.535 | — |
| SECONDARY Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) |
1.578; 1.493; 1.519 | — |
| SECONDARY Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) |
1.335; 1.246; 1.194 | — |
| SECONDARY Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) |
0.919; 1.019; 0.935 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01225952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.