Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus
- Conditions
- Keratoconus
- Interventions
- Procedure: Riboflavin/UVA crosslinkingProcedure: Sham treatment
- Registration Number
- NCT00626717
- Lead Sponsor
- University Hospital Freiburg
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Only early Keratoconus (Contact lens fitting)
- Progression of Ametropia.
- Corneal thickness > 450µm
- Further ophthalmic diseases
- History of ocular surgery
- Pregnancy, brest feeding
- Allergy against Riboflavin
- End stage Keratoconus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Riboflavin/UVA crosslinking - 2 Sham treatment -
- Primary Outcome Measures
Name Time Method Endothelial cell loss 3 years Keratoconus progression 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Eye Hospital Freiburg
🇩🇪Freiburg, Baden-Württemberg, Germany