NCT00626717

Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital Freiburg · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Background: Corneal cross linking is a procedure that induces collagen cross linking of the corneal stroma due to release of reactive oxygen radicals upon activation of topically applied riboflavine A by UVA exposure. This procedure might be capable of reducing keratocouns progression. Purpose: Although there are no randomised controlled trials on the effectiveness of corneal cross linking for the treatment of keratoconus it gains more and more importance in the general clinical setting. Therefore, the investigators started such randomised, placebo controlled, double blinded, multicenter trial to find out if this treatment is as effective as it promises to be. Methods: Randomised, placebo controlled, double blinded, multicenter trial.

Conditions

• Keratoconus

Interventions

Type	Name	Description
PROCEDURE	Riboflavin/UVA crosslinking	Removal of epithelium. Riboflavin eye drops. UVA exposure.
PROCEDURE	Sham treatment	Fluorescein eye drops. Exposure with blue light

Timeline

• Start date: 2007-08-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-02-29
• Last updated: 2013-01-17

Locations

1 site across 1 country: Germany