Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System

Phase 4

Completed

• Conditions: Cataract; Aphakia
• Interventions: Procedure: Coaxial Micro-Incision Cataract Surgery; Procedure: Coaxial Small Incision Cataract Surgery

• Registration Number: NCT01261975
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2010-04
• Study Completion: 2010-07
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Results First Submitted: 2011-09-21
• Status Verified: 2012-01
• Results First Submitted QC: 2012-01-24
• Last Update Submitted: 2012-01-24
• Results First Posted: 2012-02-27
• Last Update Posted: 2012-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coaxial Micro-Incision Cataract Surgery	Coaxial Micro-Incision Cataract Surgery	1.8 mm coaxial microincision
Coaxial Small Incision Cataract Surgery	Coaxial Small Incision Cataract Surgery	2.75 mm standard incision

Primary Outcome Measures

Name	Time	Method
Refractive Stability	12 weeks	Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.

Secondary Outcome Measures

Name	Time	Method
Surgically Induced Astigmatism (SIA)	Visits 4-8	Surgically induced astigmatism presented in dioptres at each visit.
Best Corrected Visual Acuity	visit 5, visit 6, visit 7, visit 8	Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from baseline summarized by visit. A minus change represents an improvement of the visual acuity.
Uncorrected Visual Acuity	visit 5, visit 6, visit 7, visit 8	Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.