Phase 4
Completed N=78
Evaluation of 3 Intraocular Lenses Following Lens Extraction
Source: ClinicalTrials.gov NCT01122576 ↗Enrolled (actual)
78
Serious AEs
5.4%
Results posted
Mar 2014
Primary outcomePrimary: Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree — 1.494; 1.576; 1.410; 1.613 log contrast sensitivity units
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.
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 | — |
| 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 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 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 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 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 | — |
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. Informational only — not medical advice.