Phase 4
N=36
Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
Cataract · Aphakia
Bottom Line
View on ClinicalTrials.gov: NCT01261975 ↗Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Feb 2012
Primary outcome: Primary: Refractive Stability — 17; 23; 25; 25 Eyes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Coaxial Micro-Incision Cataract Surgery (Procedure); Coaxial Small Incision Cataract Surgery (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Refractive Stability |
17; 23; 25; 25; 27; 27 | — |
| SECONDARY Best Corrected Visual Acuity |
-0.40; -0.40; -0.39; -0.42; -0.40; -0.42 | — |
| SECONDARY Best Corrected Visual Acuity |
-0.40; -0.40; -0.39; -0.42; -0.40; -0.42 | — |
| SECONDARY Uncorrected Visual Acuity |
-0.36; -0.48; -0.35; -0.47; -0.36; -0.49 | — |
| SECONDARY Uncorrected Visual Acuity |
-0.36; -0.48; -0.35; -0.47; -0.36; -0.49 | — |
| SECONDARY Surgically Induced Astigmatism (SIA) |
0.44; 0.52; 0.39; 0.53; 0.37; 0.59 | — |
| SECONDARY Surgically Induced Astigmatism (SIA) |
0.44; 0.52; 0.39; 0.53; 0.37; 0.59 | — |
Summary
The objective of this study is to test the hypothesis that the time to reach a stable refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision Enhancement System.
Eligibility Criteria
Inclusion Criteria
- Subjects must be undergoing bilateral primary in-the-bag intraocular lens (IOL) implantation for the correction of aphakia.
- Subject's ocular media must be clear except for the presence of the cataract in both eyes.
Exclusion Criteria
- Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of the study.
Data sourced from ClinicalTrials.gov (NCT01261975). 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.