Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial (NCT01604135) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial
Sweden36 participantsStarted 2012-05
Plain-language summary
The purpose of this study is to determine whether corneal collagen crosslinking is effective in the treatment of progressive keratoconus.
Who can participate
Age range18 Years – 30 Years
SexALL
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Inclusion Criteria:
* Keratoconus diagnosis determined clinically and topographically (KISA%- index)
* Significant progression is defined as change (increase) of Kmax by at least
1D from baseline at 6 months and/or change (increase) of Sim-K-ast by at least 1D from baseline at 6 months. Kmax is defined as the steepest radius of curvature (either the maximum simulated K-reading or the maximum K-reading in the 3-mm zone or the 5-mm zone) of the anterior corneal surface that progressed the most during 6 months observation
* Ability to stop contact lens (rigid and soft) wear at least two weeks prior to next exam
* Signed written informed consent
Exclusion Criteria:
* Age \< 18 years
* Pregnancy
* Breast feeding
* History of corneal surgery
* History of ocular herpes simplex infection
* Minimal corneal thickness \< 300 micrometers
* Recurrent corneal erosions
* Other corneal (e g endothelial) or conjunktival diseases
* Neurodermatitis
* Severe forms av atopic disease
* Collagenoses, autoimmune or other systemic disease
* Systemic treatment with high doses of steroids
* Severe scarring och striae of the cornea
Relative exclusion criteria:
* Kmax \> 58D
* Minimal corneal thickness \< 400 micrometers (a modified CXL-treatment will be used swelling the cornea before UV-illumination treatment).