At a glance
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Cross-linking for Corneal Ulcers Treatment Trial
In Brief
A Phase 3 clinical trial evaluating Corneal Cross-linking and Anti Fungal Drug for Corneal Ulcer and 3 related conditions. Completed, enrolled 147 participants across 2 sites in 2 countries.
Detailed Summary
The primary purpose of this study is to determine if patients randomized to corneal collagen cross-linking plus medical therapy will have a lower prevalence of positive bacterial or fungal cultures immediately after the procedure than patients who received medical therapy alone. The secondary purpose of this study is to determine if patients randomized to corneal collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who receive medical therapy alone.
Study Details
Timeline
Interventions
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
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