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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

February 20, 2008
January 16, 2013
August 2007
December 2012   (final data collection date for primary outcome measure)
  • Keratoconus progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Endothelial cell loss [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00626717 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus
Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Keratoconus
  • Procedure: Riboflavin/UVA crosslinking
    Removal of epithelium. Riboflavin eye drops. UVA exposure.
  • Procedure: Sham treatment
    Fluorescein eye drops. Exposure with blue light
  • Experimental: 1
    Intervention: Procedure: Riboflavin/UVA crosslinking
  • Sham Comparator: 2
    Intervention: Procedure: Sham treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00626717
FR-03-CCL
No
D Dr. Philip Maier, University Hospital Freiburg
University Hospital Freiburg
Peschke Meditrade, GmbH
Principal Investigator: Philip Maier, MD University Eye Hospital Freiburg
University Hospital Freiburg
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP