Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus

Keratoconus Clinical Trial

— CCL  

Official title:

Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626717
• Other study ID #: FR-03-CCL
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 20, 2008
• Last updated: January 16, 2013
• Start date: August 2007
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Riboflavin/UVA crosslinking
Removal of epithelium. Riboflavin eye drops. UVA exposure.
• Sham treatment
Fluorescein eye drops. Exposure with blue light

Locations

Country	Name	City	State
Germany	University Eye Hospital Freiburg	Freiburg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Freiburg	Peschke Meditrade, GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Keratoconus progression		3 years	No
Primary	Endothelial cell loss		3 years	Yes