Light for Ulcer Management by Infection Elimination and Resistance Enhancement (LUMIERE)
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).
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Presence of culture positive fusarium fungal keratitis * Age over 18 years * Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) to 20/400 (6/120) * Corneal thickness ≥350 µm, as measured on AS-OCT * Basic understanding of the study as determined by the physician * Commitment to return for follow up visits Exclusion Criteria: * History of hypersensitivity to Rose Bengal * Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthamoeba on gram stain) * History of intraocular surgery…
Interventions
- DrugRose 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.
- DrugSham 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 UniversityPalo Alto, California
- University of Miami - Bascom Palmer Eye InstituteMiami, Florida
- Federal University of São PauloSão Paulo
- Aravind Eye Care SystemMadurai, Tamil Nadu