Phase 4
N=75
Clinical Evaluation of a New Aspheric Intraocular Lens.
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT00786565 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcome: Primary: Low Contrast Best Corrected Visual Acuity Following Cataract Surgery — 0.22; 0.24 LogMAR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Advanced Akreos Adapt in one operated eye. (Device); Akreos Adapt in fellow operated eye. (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Low Contrast Best Corrected Visual Acuity Following Cataract Surgery |
0.22; 0.24 | — |
| PRIMARY Low Contrast Uncorrected Visual Acuity Following Cataract Surgery |
0.33; 0.35 | — |
| PRIMARY Photopic Contrast Sensitivity |
44.4; 41.1; 78.3; 81.1; 89.6; 86.4 | — |
| PRIMARY Mesoptic Contrast Sensitivity |
51.2; 47.4; 65.6; 58.1; 52.9; 45.6 | — |
| PRIMARY Posterior Capsule Opacification Score |
0.05; 0.14; 0.12; 0.20 | — |
| SECONDARY High Contrast Visual Acuity |
0.17; 0.22; 0.05; 0.07 | — |
| SECONDARY High Contrast Visual Acuity Uncorrected |
0.22; 0.27 | — |
| SECONDARY High Contrast Visual Acuity Best Corrected |
0.11; 0.15 | — |
| SECONDARY High Contrast Visual Acuity |
0.17; 0.22; 0.05; 0.07 | — |
| SECONDARY High Contrast Visual Acuity Uncorrected |
0.22; 0.27 | — |
| SECONDARY High Contrast Visual Acuity Best Corrected |
0.11; 0.15 | — |
| SECONDARY Low Contrast Visual Acuity |
0.33; 0.36; 0.21; 0.24 | — |
| SECONDARY Contrast Sensitivity Photopic 1.5cpd |
39.2; 39.9 | — |
| SECONDARY Contrast Sensitivity Photopic |
76.6; 64.0; 92.4; 70.5; 30.3; 22.3 | — |
| SECONDARY Contrast Sensitivity Mesoptic 1.5 Cpd |
46.6; 40.8 | — |
| SECONDARY Contrast Sensitivity Mesoptic |
58.2; 51.5; 55.9; 39.4; 9.2; 6.7 | — |
| SECONDARY Posterior Capsule Opacification |
0.03; 0.06; 0.07; 0.13 | — |
Summary
This study evaluates the visual performance and occurrence of posterior capsular opacification after implantation of a new aspherical intraocular lens compared with a control spherical lens of otherwise identical design.
Eligibility Criteria
Inclusion Criteria
- Patients must have a clinically documented diagnosis of bilateral cataract (either cortical, nuclear, subcapsular or a combination) liable to benefit from standard cataract surgery.
- Patients must be undergoing primary cataract surgery with IOL in-the-bag implantation, requiring a IOL power from 10 to 30 diopters.
Exclusion Criteria
- Patients with corneal damage.
- Patients with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- Patients with any ocular pathology, other than the cataract, having repercussions on visual function:
Data sourced from ClinicalTrials.gov (NCT00786565). 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.