Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus (CCL)

This study has been completed.
Peschke Meditrade, GmbH
Information provided by (Responsible Party):
D Dr. Philip Maier, University Hospital Freiburg
ClinicalTrials.gov Identifier:
First received: February 20, 2008
Last updated: January 16, 2013
Last verified: January 2013

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.

Condition Intervention Phase
Procedure: Riboflavin/UVA crosslinking
Procedure: Sham treatment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus

Resource links provided by NLM:

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Keratoconus progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Endothelial cell loss [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: August 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: Riboflavin/UVA crosslinking
Removal of epithelium. Riboflavin eye drops. UVA exposure.
Sham Comparator: 2 Procedure: Sham treatment
Fluorescein eye drops. Exposure with blue light


Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00626717

University Eye Hospital Freiburg
Freiburg, Baden-Württemberg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
Peschke Meditrade, GmbH
Principal Investigator: Philip Maier, MD University Eye Hospital, Freiburg
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: D Dr. Philip Maier, PD Dr. med., University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT00626717     History of Changes
Other Study ID Numbers: FR-03-CCL 
Study First Received: February 20, 2008
Last Updated: January 16, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Freiburg:
Cross linking

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases
Dermatologic Agents
Growth Substances
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamin B Complex

ClinicalTrials.gov processed this record on May 03, 2016