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RB-PDT for Fusarium Keratitis: The LUMIERE Study
Sponsor: Stanford University
Summary
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).
Official title: Light for Ulcer Management by Infection Elimination and Resistance Enhancement (LUMIERE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
434
Start Date
2027-01
Completion Date
2030-01
Last Updated
2026-08-04
Healthy Volunteers
No
Conditions
Interventions
Rose Bengal Photodynamic 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). A second RB-PDT procedure and repeat smear/culture will occur one week after the first procedure, following the same protocol.
Sham RB-PDT
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 sham RB-PDT procedure and repeat smear/culture will occur one week after the first procedure, following the same protocol.
Locations (4)
Stanford University
Palo Alto, California, United States
University of Miami - Bascom Palmer Eye Institute
Miami, Florida, United States
Federal University of São Paulo
São Paulo, Brazil
Aravind Eye Care System
Madurai, Tamil Nadu, India