Corneal Crosslinking in Keratoconus and Corneal Ectasia (CXL)
Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia|
- change in keratometry [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- best spectacle-corrected visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Sham Comparator: Sham treatment
Subjects are randomized to control (sham) group or a treatment group with the control group crossed over to the treatment group at the 3 month visit.
Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.
Active Comparator: Treatment Arm
After randomization, the active arm will have the collagen crosslinking intervention.
01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes
Other Name: Vitamin B2
After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|OSU Havener Eye Institute|
|Dublin, Ohio, United States, 43016|
|Principal Investigator:||Richard Keates, MD||The Ohio State Univesity|