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 ]

The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.


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