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

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ClinicalTrials.gov Identifier: NCT00626717
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : January 17, 2013
Sponsor:
Collaborator:
Peschke Meditrade, GmbH
Information provided by (Responsible Party):
D Dr. Philip Maier, University Hospital Freiburg

Brief 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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus
Study Start Date : August 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Keratoconus progression [ Time Frame: 3 years ]
  2. Endothelial cell loss [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

Keywords provided by D Dr. Philip Maier, University Hospital Freiburg:
Keratoconus
Cross linking
Riboflavin

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents