Ireland
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Active, not recruiting Phase 3

Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial

NCT01604135 · tracked via the Priya Life Science Sweden tracker
Phase
Phase 3
Started
2012-05
Last updated
2026-05-11

Condition(s) studied

Keratoconus

Investigational drug(s) / intervention(s)

Corneal Collagen Crosslinking

Corneal Collagen Crosslinking: Keratoconic corneas that show significant progression as specified in the inclusion criteria section will receive one single treatment with CXL if randomized to the treatment arm. A treatment protocol based on 30 minutes dropping with riboflavin/dextran solution and 10 minutes UV-illumination treatment will be used.

Study summary

The purpose of this study is to determine whether corneal collagen crosslinking is effective in the treatment of progressive keratoconus.

Eligibility

Sex
ALL
Min age
18 Years
Max age
30 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Kmax — 12 months
    Kmax is defined as the steepest radius of curvature of the anterior corneal surface. It is measured by Scheimpflug-topography (Pentacam, Oculus Inc.). An increase of less than 1 diopter (D) from baseline at 12 months is defined as non-progression.

Trial sites (1)

FacilityCityRegionStatus
Department of Ophthalmology, Sahlgrenska University Hospital Mölndal Västra Götalandsregionen
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01604135 on ClinicalTrials.gov ↗ ← All trials in Sweden