Clinical Trial: Corrected VA With Long-Term Follow-Up After AcrySof® Intraocular Lens (IOL) Implantation

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

Official Title: Corrected VA With Long-Term Follow-Up After AcrySof® IOL Implantation

Brief Summary: The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will take place in Japan.

Detailed Summary:
Sponsor: Alcon, a Novartis Company

Current Primary Outcome: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit [ Time Frame: Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation) ]

Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.


Original Primary Outcome: Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit [ Time Frame: Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation) ]

VA will be assessed with subject's best spectacle correction or other visual corrective device in place. VA will be measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. One eye (study eye) will contribute to the analysis.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Alcon Research

Dates:
Date Received: May 19, 2015
Date Started: June 2015
Date Completion:
Last Updated: October 17, 2016
Last Verified: October 2016