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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
Information provided by (Responsible Party):

February 20, 2008
February 29, 2008
January 17, 2013
August 2007
December 2012   (Final data collection date for primary outcome measure)
  • Keratoconus progression [ Time Frame: 3 years ]
  • Endothelial cell loss [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT00626717 on ClinicalTrials.gov Archive Site
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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.

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Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • 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
Lang SJ, Messmer EM, Geerling G, Mackert MJ, Brunner T, Dollak S, Kutchoukov B, Böhringer D, Reinhard T, Maier P. Prospective, randomized, double-blind trial to investigate the efficacy and safety of corneal cross-linking to halt the progression of keratoconus. BMC Ophthalmol. 2015 Jul 21;15:78. doi: 10.1186/s12886-015-0070-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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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