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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01261975
First received: December 15, 2010
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cataract
Aphakia
 Procedure: Coaxial Micro-Incision Cataract Surgery
Procedure: Coaxial Small Incision Cataract Surgery
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Co-Axial Micro-incision Cataract Surgery(C-MICS) Versus Standard Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Refractive Stability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Best Corrected Visual Acuity [ Time Frame: Visit 1, visit 2, visit 3, visit 4 ] [ Designated as safety issue: No ]
    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

  • Best Corrected Visual Acuity [ Time Frame: visit 5, visit 6, visit 7, visit 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Visit 1, visit 2, visit 3, visit 4 ] [ Designated as safety issue: No ]
    Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.

  • Uncorrected Visual Acuity [ Time Frame: visit 5, visit 6, visit 7, visit 8 ] [ Designated as safety issue: No ]
    Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.

  • Surgically Induced Astigmatism (SIA) [ Time Frame: Visits 1-3 ] [ Designated as safety issue: No ]
    Surgically induced astigmatism was presented in dioptres at each visit.

  • Surgically Induced Astigmatism (SIA) [ Time Frame: Visits 4-8 ] [ Designated as safety issue: No ]
    Surgically induced astigmatism presented in dioptres at each visit.


Enrollment: 36
Study Start Date: August 2009
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coaxial Micro-Incision Cataract Surgery
1.8 mm coaxial microincision
 Procedure: Coaxial Micro-Incision Cataract Surgery
1.8 mm coaxial micro incision
Other Name: 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 Name: Stellaris Vision Enhancement System

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261975

Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Anne Williart, MD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01261975     History of Changes
Other Study ID Numbers: 607
Study First Received: December 15, 2010
Results First Received: September 21, 2011
Last Updated: January 24, 2012
Health Authority: European Union: European Medicines Agency

Keywords provided by Bausch & Lomb Incorporated:
Ocular Surgery
Intraocular Lens

Additional relevant MeSH terms:
Aphakia
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013