Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus
NCT ID: NCT00626717
Last Updated: 2013-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2007-08-31
2012-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Riboflavin/UVA crosslinking
Removal of epithelium. Riboflavin eye drops. UVA exposure.
2
Sham treatment
Fluorescein eye drops. Exposure with blue light
Interventions
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Riboflavin/UVA crosslinking
Removal of epithelium. Riboflavin eye drops. UVA exposure.
Sham treatment
Fluorescein eye drops. Exposure with blue light
Eligibility Criteria
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Inclusion Criteria
* Progression of Ametropia.
* Corneal thickness \> 450µm
Exclusion Criteria
* History of ocular surgery
* Pregnancy, brest feeding
* Allergy against Riboflavin
* End stage Keratoconus
12 Years
ALL
No
Sponsors
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Peschke Meditrade, GmbH
INDUSTRY
University Hospital Freiburg
OTHER
Responsible Party
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D Dr. Philip Maier
PD Dr. med.
Principal Investigators
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Philip Maier, MD
Role: PRINCIPAL_INVESTIGATOR
University Eye Hospital, Freiburg
Locations
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University Eye Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Countries
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References
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Lang SJ, Messmer EM, Geerling G, Mackert MJ, Brunner T, Dollak S, Kutchoukov B, Bohringer 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.
Other Identifiers
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FR-03-CCL
Identifier Type: -
Identifier Source: org_study_id
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