Corneal Crosslinking in Keratoconus and Corneal Ectasia (CXL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00679666|
Recruitment Status : Withdrawn (Investigator no longer at university)
First Posted : May 19, 2008
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Progressive Keratoconus Corneal Ectasia||Drug: Riboflavin Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia|
|Study Start Date :||April 2008|
|Primary Completion Date :||April 2010|
|Study Completion Date :||October 2010|
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
- change in keratometry [ Time Frame: 3 months ]
- best spectacle-corrected visual acuity [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679666
|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|