NCT02570321

Cross-linking for Corneal Ulcers Treatment Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed study is a randomized controlled trial to determine whether collagen cross-linking improves outcomes in microbial keratitis. Patients presenting to the Aravind Eye Hospitals in Madurai, India for treatment of microbial keratitis will be recruited for the proposed study. Approximately 266 patients will be enrolled in the study. Subjects presenting with bacterial keratitis will be randomized to receive medical therapy plus corneal collagen cross-linking at presentation or to receive medical therapy alone. All subjects with bacterial ulcers will receive standard topical antibiotic medications as required after the procedure. Subjects with fungal keratitis will be randomized into one of four groups: 1. collagen cross-linking + amphotericin; 2. collagen cross-linking + natamycin; 3. amphotericin alone; 4. natamycin alone. All study subjects will be followed for 12 months to evaluate response to treatment. Investigators from the University of California, San Francisco (UCSF) will assist Aravind Eye Hospital with the study design, implementation, and analysis of the research, and will help fund the study. The investigators plan to visit Aravind to help with the study implementation. UCSF will play an important role in this study by assisting with the study design, implementation, analysis, and funding.

Conditions

• Corneal Ulcer
• Infectious Keratitis
• Bacterial Ulcer
• Fungal Ulcer

Interventions

Type	Name	Description
PROCEDURE	Corneal Cross-linking	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.
DRUG	Anti Fungal Drug	Topical Amphotericin B vs Topical Natamycin

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-06-18
• Completion: 2019-03-19
• First posted: 2015-10-07
• Last updated: 2025-06-18
• Results posted: 2024-08-27

Locations

2 sites across 2 countries: United States, India

Regulatory

• FDA-regulated drug study