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

NCT ID: NCT01261975

Last Updated: 2012-02-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Cataract Aphakia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Coaxial Micro-Incision Cataract Surgery

1.8 mm coaxial microincision

Group Type EXPERIMENTAL

Coaxial Micro-Incision Cataract Surgery

Intervention Type PROCEDURE

1.8 mm coaxial micro incision

Coaxial Small Incision Cataract Surgery

2.75 mm standard incision

Group Type ACTIVE_COMPARATOR

Coaxial Small Incision Cataract Surgery

Intervention Type PROCEDURE

2.75 mm coaxial incision

Interventions

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Coaxial Micro-Incision Cataract Surgery

1.8 mm coaxial micro incision

Intervention Type PROCEDURE

Coaxial Small Incision Cataract Surgery

2.75 mm coaxial incision

Intervention Type PROCEDURE

Other Intervention Names

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Stellaris Vision Enhancement System Stellaris Vision Enhancement System

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Williart, MD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Other Identifiers

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607

Identifier Type: -

Identifier Source: org_study_id

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