NCT00435799

Evaluating Collagen Cross-Linking (CCL) Treatment in Norway

Treatment of Keratectasia With Collagen Cross-Linking (CCL) at the Eye Departments of the University Hospital, North Norway in Tromsø and Ullevål University Hospital in Oslo

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ullevaal University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in improving visual acuity. This is the first Norwegian study concerning CCL.

Detailed description

The technique of corneal collagen cross-linking consists of photopolymerization of stromal fibers by combined action of a photosensitizing substance, riboflavin and ultraviolet type A rays (UVA) from a solid-state UVA Source. Photopolymerization increases the rigidity of corneal collagen and its resistance to keratectasia. It has been used to stop progression of keratectasia. Corneal transplantation has been the only available option so far for treatment for keratectasia in its advanced stage in Norway. The method of CCL using riboflavin and UV light is technically simple and much less invasive than corneal transplantation and it treats and prevents the underlying pathophysiological mechanism. It also does not reduce the chances for a successful corneal transplantation, in case that would still be necessary after CCL. The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in improving visual acuity. This is the first Norwegian study concerning CCL.

Conditions

• Keratoconus

Interventions

Type	Name	Description
PROCEDURE	corneal cross-linking (CCL)
DRUG	Riboflavin/dextran eyedrops
DEVICE	UV-X system

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-01-01
• Completion: 2010-01-01
• First posted: 2007-02-15
• Last updated: 2008-06-10

Locations

2 sites across 1 country: Norway