Phase 4
Completed N=36
Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
Cataract · Aphakia
Source: ClinicalTrials.gov NCT01261975 ↗
Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Feb 2012
Primary outcomePrimary: Refractive Stability — 17; 23; 25; 25 Eyes
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.
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 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 | — |
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. Informational only — not medical advice.