Phase 4
N=78
Evaluation of 3 Intraocular Lenses Following Lens Extraction
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT01122576 ↗Enrolled (actual)
78
Serious AEs
5.4%
Results posted
Mar 2014
Primary outcome: Primary: Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree — 1.494; 1.576; 1.410; 1.613 log contrast sensitivity units
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Crystalens AO (Device); ReSTOR (Device); Tecnis Multifocal IOL (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree |
1.494; 1.576; 1.410; 1.613; 1.679; 1.528 | — |
| PRIMARY Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree |
1.610; 1.622; 1.543 | — |
| PRIMARY Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree |
1.229; 1.218; 1.217 | — |
| PRIMARY Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree |
0.998; 0.789; 0.896 | — |
| PRIMARY Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree |
1.525; 1.588; 1.408 | — |
| PRIMARY Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree |
1.638; 1.698; 1.519 | — |
| PRIMARY Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree |
1.610; 1.622; 1.543 | — |
| PRIMARY Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree |
1.229; 1.218; 1.217 | — |
| PRIMARY Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree |
0.998; 0.789; 0.896 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree |
1.688; 1.749; 1.537; 1.775; 1.797; 1.667 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree |
1.731; 1.677; 1.593 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree |
1.261; 1.273; 1.235 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree |
1.160; 1.008; 0.885 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree |
1.712; 1.743; 1.537; 1.785; 1.768; 1.594 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree |
1.261; 1.273; 1.235 | — |
| SECONDARY Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree |
1.160; 1.008; 0.885 | — |
| SECONDARY Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree |
1.343; 1.367; 1.199 | — |
| SECONDARY Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree |
1.536; 1.462; 1.367 | — |
| SECONDARY Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree |
1.535; 1.475; 1.413 | — |
| SECONDARY Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree |
1.341; 1.272; 1.190 | — |
| SECONDARY Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree |
1.139; 1.192; 0.849 | — |
| SECONDARY Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree |
1.343; 1.367; 1.199 | — |
| SECONDARY Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree |
1.536; 1.462; 1.367 | — |
| SECONDARY Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree |
1.535; 1.475; 1.413 | — |
| SECONDARY Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree |
1.341; 1.272; 1.190 | — |
| SECONDARY Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree |
1.139; 1.192; 0.849 | — |
| SECONDARY Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree |
1.392; 1.404; 1.344; 1.573; 1.493; 1.410 | — |
| SECONDARY Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree |
1.519; 1.515; 1.448 | — |
| SECONDARY Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree |
1.321; 1.319; 1.337 | — |
| SECONDARY Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree |
1.175; 1.101; 1.060 | — |
| SECONDARY Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree |
1.392; 1.404; 1.344; 1.573; 1.493; 1.410 | — |
| SECONDARY Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree |
1.519; 1.515; 1.448 | — |
| SECONDARY Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree |
1.321; 1.319; 1.337 | — |
| SECONDARY Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree |
1.175; 1.101; 1.060 | — |
| SECONDARY Optical Scatter |
1.1308; 1.9760; 1.8318 | — |
| SECONDARY Optical Scatter |
1.1308; 1.9760; 1.8318 | — |
| SECONDARY Monocular Halo and Starburst |
1.2; 1.5; 1.8; 4.6; 4.7; 4.5 | — |
| SECONDARY Monocular Halo and Starburst |
1.2; 1.5; 1.8; 4.6; 4.7; 4.5 | — |
| SECONDARY Binocular Halo and Starburst |
1.3; 1.8; 2.0; 4.6; 4.9; 4.5 | — |
| SECONDARY Binocular Halo and Starburst |
1.3; 1.8; 2.0; 4.6; 4.9; 4.5 | — |
| SECONDARY Manifest Refraction |
-0.339; 0.145; -0.091 | — |
| SECONDARY Manifest Refraction |
-0.339; 0.145; -0.091 | — |
| SECONDARY Uncorrected Distance Visual Acuity |
0.122; 0.002; 0.072; 0.113; 0.016; 0.060 | — |
| SECONDARY Best-corrected Distance Visual Acuity |
-0.100; -0.094; -0.068; -0.100; -0.096; -0.075 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01122576). 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.