Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus

Phase 2

Completed

• Conditions: Keratoconus

• 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

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-02-29
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Only early Keratoconus (Contact lens fitting)
• Progression of Ametropia.
• Corneal thickness > 450µm

Exclusion Criteria

• Further ophthalmic diseases
• History of ocular surgery
• Pregnancy, brest feeding
• Allergy against Riboflavin
• End stage Keratoconus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endothelial cell loss	3 years
Keratoconus progression	3 years

Trial Locations

Locations (1)

University Eye Hospital Freiburg; 🇩🇪 Freiburg, Baden-Württemberg, Germany