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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome: 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.


Original Primary Outcome: Time to refractive stability [ Time Frame: 12 weeks ]

Refractive stability is the time in days when manifest refractive stability equivalent(MRSE) is first within 0.5 D of final MRSE and stays within 0.5 D of the final value for the remainder of the trial.


Current Secondary Outcome:

  • 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
  • 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.
  • 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.
  • 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.
  • Surgically Induced Astigmatism (SIA) [ Time Frame: Visits 1-3 ]
    Surgically induced astigmatism was presented in dioptres at each visit.
  • Surgically Induced Astigmatism (SIA) [ Time Frame: Visits 4-8 ]
    Surgically induced astigmatism presented in dioptres at each visit.


Original Secondary Outcome: Surgically Induced Astigmatism (SIA) [ Time Frame: 12 weeks ]

Surgically induced astigmatism will be assessed using a manual keratometer at the screening and all postoperative visits.


Information By: Bausch & Lomb Incorporated

Dates:
Date Received: December 15, 2010
Date Started: August 2009
Date Completion:
Last Updated: January 24, 2012
Last Verified: January 2012