- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00626717
Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus (CCL)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Baden-Württemberg
-
Freiburg, Baden-Württemberg, Germany, 79106
- University eye hospital Freiburg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Removal of epithelium.
Riboflavin eye drops.
UVA exposure.
|
Sham Comparator: 2
|
Fluorescein eye drops.
Exposure with blue light
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Keratoconus progression
Time Frame: 3 years
|
3 years
|
Endothelial cell loss
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip Maier, MD, University Eye Hospital, Freiburg
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FR-03-CCL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Glaukos CorporationTerminatedHyperopia | Hyperopic AstigmatismUnited States
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Peschke Meditrade, GmbHUnknown