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

This study has been completed.
Sponsor:
Collaborator:
Peschke Meditrade, GmbH
Information provided by (Responsible Party):
D Dr. Philip Maier, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00626717
First received: February 20, 2008
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Keratoconus
 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:

Drug Information available for: Riboflavin
U.S. FDA Resources

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

  Eligibility

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

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

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

No publications provided

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:
Keratoconus
Cross linking
Riboflavin

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

ClinicalTrials.gov processed this record on May 23, 2013