Evaluating Collagen Cross-Linking (CCL) Treatment in Norway
|ClinicalTrials.gov Identifier: NCT00435799|
Recruitment Status : Unknown
Verified January 2007 by Ullevaal University Hospital.
Recruitment status was: Recruiting
First Posted : February 15, 2007
Last Update Posted : June 10, 2008
|Condition or disease||Intervention/treatment||Phase|
|Keratoconus||Procedure: corneal cross-linking (CCL) Drug: Riboflavin/dextran eyedrops Device: UV-X system||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||February 2007|
|Estimated Primary Completion Date :||January 2009|
|Estimated Study Completion Date :||January 2010|
|Active Comparator: A||
Procedure: corneal cross-linking (CCL)
Drug: Riboflavin/dextran eyedrops
Device: UV-X system
- 1 Efficacy will be evaluated based on: a. reduction of keratometry (curvature) values, b. improvement in distance best spectacle corrected visual acuity (BSCVA) and c. improvement in patients visual disturbances.
- 2 Stability of the treatment will be evaluated based on keratometry and on manifest refraction spherical equivalent (MRSE).
- 3 Safety will be evaluated based on the changes in distance best spectacle corrected visual acuity (BSCVA).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435799
|Contact: ALEKSANDAR STOJANOVIC, MD||+47 77 64 79 email@example.com|
|Contact: ESPEN F BAKKE, MD||+47 firstname.lastname@example.org|
|Eye dpt, Ullevål University Hospital||Recruiting|
|Oslo, Norway, N-0407|
|Contact: Liv Drolsum, Prof MD PhD +47 22118545 email@example.com|
|Contact: Espen F Bakke, MD +47 22118545 firstname.lastname@example.org|
|Principal Investigator: Liv Drolsum, Prof MD PhD|
|Eye dpt, University Hospital North Norway||Recruiting|
|Tromsø, Norway, No-9037|
|Contact: Aleksandar Stojanovic, MD +47 77 64 79 20 email@example.com|
|Principal Investigator: Aleksandar Stojanovic, MD|
|Principal Investigator:||Aleksandar Stojanovic, MD||Eye dpt, University Hospital of North Norway|