Keratoconus
Conditions
Keywords
Keratoconus, Cross linking, Riboflavin
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.
Interventions
PROCEDURERiboflavin/UVA crosslinking
Removal of epithelium. Riboflavin eye drops. UVA exposure.
PROCEDURESham treatment
Fluorescein eye drops. Exposure with blue light
Sponsors
Peschke Meditrade, GmbH
University Hospital Freiburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Keratoconus progression | 3 years |
| Endothelial cell loss | 3 years |
Countries
Germany
Outcome results
None listed