Clinical Trial: Corneal Collagen Cross-Linking for Ectasia (CXL)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery
Brief Summary: Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.
Detailed Summary: Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.
Sponsor: Avedro, Inc.
Current Primary Outcome: Mean Change From Baseline in Maximum Keratometry (Kmax) [ Time Frame: baseline,12 months ]
Original Primary Outcome: Change in keratomerty [ Time Frame: 3 months ]
Current Secondary Outcome:
Original Secondary Outcome: Bestspectacle-corrected visual acuity [ Time Frame: 3 months ]
Information By: Avedro, Inc.
Dates:
Date Received: May 6, 2008
Date Started: December 2007
Date Completion:
Last Updated: December 2, 2016
Last Verified: December 2016