Cross-linking for Corneal Ulcers Treatment Trial — CLAIR  

Corneal Ulcer Clinical Trial

Official title: Cross-linking for Corneal Ulcers Treatment Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bacterial Ulcer
• Communicable Diseases
• Corneal Ulcer
• Fungal Ulcer
• Infection
• Infectious Keratitis
• Keratitis
• Ulcer

• NCT number: NCT02570321
• Study type: Interventional
• Source: University of California, San Francisco
• Contact: Jennifer R Rose-Nussbaumer, MD
• Phone: 415-502-2666
• Email: Jennifer.Rose-Nussbaumer@ucsf.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: November 2015
• Completion date: November 2020