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| Sponsors and Collaborators: |
University Hospital Freiburg PESCHKE Meditrade GmbH, Switzerland University Eye Hospital Bochum University Eye Hospital Muenchen University Eye Hospital Tuebingen University Eye Hospital Wuerzburg |
|---|---|
| Information provided by: | University Hospital Freiburg |
| ClinicalTrials.gov Identifier: | NCT00626717 |
Purpose
Background: Corneal cross linking is a procedure that induces collagen cross linking of the corneal stroma due to release of reactive oxigen 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 effectivity of corneal cross linking for the treatment of keratoconus it gains more and more importance in the general clinical setting. Therefore, we 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Keratoconus |
Procedure: Riboflavin/UVA crosslinking Procedure: Sham treatment |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus |
| Estimated Enrollment: | 130 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Procedure: Riboflavin/UVA crosslinking
Removal of epithelium. Riboflavin eye drops. UVA exposure.
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| 2: Sham Comparator |
Procedure: Sham treatment
Fluorescein eye drops. Exposure with blue light
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Philip Maier, MD | +49 761 270 4001 | philip.maier@uniklinik-freiburg.de |
| Contact: Tobias Brunner, MD | +49 761 270 4001 | brunner@aug.ukl.uni-freiburg.de |
| Germany, Baden-Württemberg | |
| University Eye Hospital Freiburg | Recruiting |
| Freiburg, Baden-Württemberg, Germany, 79106 | |
| Contact: Philip Maier, MD +49 761 270 ext 4001 philip.maier@uniklinik-freiburg.de | |
| Principal Investigator: | Philip Maier, MD | University Eye Hospital Freiburg |
More Information
| Responsible Party: | University Eye Hospital Freiburg ( Dr. Maier ) |
| Study ID Numbers: | FR-03-CCL |
| Study First Received: | February 20, 2008 |
| Last Updated: | February 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00626717 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Keratoconus Cross linking Riboflavin |
|
Corneal Diseases Riboflavin Eye Diseases |
Disease Progression Tetrahydrozoline Keratoconus |
|
Photosensitizing Agents Vitamin B Complex Radiation-Sensitizing Agents Growth Substances Vitamins |
Therapeutic Uses Physiological Effects of Drugs Micronutrients Dermatologic Agents Pharmacologic Actions |
