RB-PDT for Fusarium Keratitis: The LUMIERE Study

Overview

This is a multicenter trial with recruitment planned at ophthalmology clinics specializing in corneal diseases in India, Brazil, and at Stanford University and Bascom Palmer Eye Institute in the United States. Fusarium keratitis is common in tropical and subtropical regions like Florida, India and Brazil, which will facilitate access to the required number of participants. The study aims to recruit a total of 434 participants (217 per group).

Participants with fusarium corneal ulcers will be randomized in a 1:1 fashion to one of two arms: * Group 1, RB-PDT: natamycin 5%/Amphotericin B 0.15% plus RB-PDT * Group 2, Sham RB-PDT: natamycin 5%/Amphotericin B 0.15% plus sham RB-PDT Participants will begin topical antimicrobial upon initial diagnosis: applied to the affected eye every hour while awake for the first week, then every 2 hours while awake for 3 weeks. Thereafter, application will be tapered at the discretion of the treating physician based on response to therapy. RB-PDT/sham RB-PDT will occur within 5 days of initial smear/culture. For Group 1, Rose Bengal (0.1% RB in 0.9% sodium chloride) will be applied in 3-minute intervals to the de-epithelialized cornea for 30 minutes followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Participants in Group 2 will undergo a sham procedure using topical balanced salt solution and pen light covered with a green filter. Study participants will undergo repeat scraping and culture of the corneal ulcer 30 minutes after the assigned RB-PDT procedure. A second RB-PDT/sham RB-PDT procedure and repeat smear/culture will occur one week after the first procedure, following the same protocol.

Conditions

Interventions

Eligibility

Locations (4)

Outcomes