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

January 24, 2012 updated by: Bausch & Lomb Incorporated

Co-Axial Micro-incision Cataract Surgery(C-MICS) Versus Standard Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Coaxial Micro-Incision Cataract Surgery
1.8 mm coaxial microincision
Procedure: Coaxial Micro-Incision Cataract Surgery
1.8 mm coaxial micro incision
Other Names:
  • Stellaris Vision Enhancement System
ACTIVE_COMPARATOR: Coaxial Small Incision Cataract Surgery
2.75 mm standard incision
Procedure: Coaxial Small Incision Cataract Surgery
2.75 mm coaxial incision
Other Names:
  • Stellaris Vision Enhancement System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refractive Stability
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity
Time Frame: Visit 1, visit 2, visit 3, visit 4
Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from preoperative visit summarized by visit. A minus change represents an improvement of the visual acuity
Visit 1, visit 2, visit 3, visit 4
Best Corrected Visual Acuity
Time Frame: 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.
visit 5, visit 6, visit 7, visit 8
Uncorrected Visual Acuity
Time Frame: Visit 1, visit 2, visit 3, visit 4
Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Visit 1, visit 2, visit 3, visit 4
Uncorrected Visual Acuity
Time Frame: visit 5, visit 6, visit 7, visit 8
Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
visit 5, visit 6, visit 7, visit 8
Surgically Induced Astigmatism (SIA)
Time Frame: Visits 1-3
Surgically induced astigmatism was presented in dioptres at each visit.
Visits 1-3
Surgically Induced Astigmatism (SIA)
Time Frame: Visits 4-8
Surgically induced astigmatism presented in dioptres at each visit.
Visits 4-8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Anne Williart, MD, Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

December 15, 2010

First Submitted That Met QC Criteria

December 16, 2010

First Posted (ESTIMATE)

December 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 27, 2012

Last Update Submitted That Met QC Criteria

January 24, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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