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

Bausch + Lomb

Status and phase: Completed; Phase 4

Conditions: Cataract; Aphakia

Treatments: Procedure: Coaxial Small Incision Cataract Surgery; Procedure: Coaxial Micro-Incision Cataract Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT01261975

607

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Coaxial Micro-Incision Cataract Surgery

Experimental group

Description:

1.8 mm coaxial microincision

Treatment:

Procedure: Coaxial Micro-Incision Cataract Surgery

Coaxial Small Incision Cataract Surgery

Active Comparator group

Description:

2.75 mm standard incision

Treatment:

Procedure: Coaxial Small Incision Cataract Surgery