Cross-linking for Corneal Ulcers Treatment Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 147
- Locations
- 2
- Primary Endpoint
- Microbiological Cure on Repeat Culture
Study Overview
Brief 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:
- collagen cross-linking + amphotericin;
- collagen cross-linking + natamycin;
- amphotericin alone;
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Fungal ulcer cross-linking plus amphotericin
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
Intervention: Anti Fungal Drug (Drug)
Bacterial ulcer cross-linking
Standard of care topical treatment for bacterial ulcer plus cross-linking
Intervention: Corneal Cross-linking (Procedure)
Bacterial ulcer control
Standard of care topical treatment for bacterial ulcer
Intervention: Corneal Cross-linking (Procedure)
Fungal ulcer cross-linking plus natamycin
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
Intervention: Corneal Cross-linking (Procedure)
Fungal ulcer cross-linking plus natamycin
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
Intervention: Anti Fungal Drug (Drug)
Fungal ulcer control with natamycin
Standard of care topical treatment for fungal ulcer with natamycin
Intervention: Corneal Cross-linking (Procedure)
Fungal ulcer control with natamycin
Standard of care topical treatment for fungal ulcer with natamycin
Intervention: Anti Fungal Drug (Drug)
Fungal ulcer cross-linking plus amphotericin
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
Intervention: Corneal Cross-linking (Procedure)
Fungal ulcer control with amphotericin
Standard of care topical treatment for fungal ulcer with amphotericin
Intervention: Corneal Cross-linking (Procedure)
Fungal ulcer control with amphotericin
Standard of care topical treatment for fungal ulcer with amphotericin
Intervention: Anti Fungal Drug (Drug)
Outcomes
Primary Outcomes
Microbiological Cure on Repeat Culture
Time Frame: 4 to 24 hours after enrollment
Corneal scraping of the ulcer will be performed and directly inoculated on to sheep's blood agar, chocolate agar, potato dextrose agar or Sabouraud's agar for bacterial and fungal culture. Microbiological cure is defined as no growth of bacteria or fungus on these media.
Secondary Outcomes
- Best Spectacle-corrected Visual Acuity(3 months)
- Scar Size(3 months)
- Adverse Events Including Rate of Perforation/Need for Therapeutic Penetrating Keratoplasty(3 months)