RB-PDT for Fusarium Keratitis: The LUMIERE Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rose Bengal Photodynamic Therapy, Sham RB-PDT.
- Who it may be relevant to
- Registry conditions: Fusarium Keratitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Brazil, India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Light for Ulcer Management by Infection Elimination and Resistance Enhancement (LUMIERE)
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).
Detailed 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/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.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- BSCVA at 3 months [Time frame: 3 months post-op]
Eligibility criteria
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 within the last three months\*
- Impending or frank perforation at recruitment
- Involvement of sclera at presentation
- Presence of desmetocele at recruitment
- Non-infectious or autoimmune keratitis
- History of corneal transplantation
- Pinhole visual acuity worse than 20/200 in the unaffected eye
- Participants who are decisionally and/or cognitively impaired
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Stanford University — Palo Alto
- University of Miami - Bascom Palmer Eye Institute — Miami
Brazil · 1 center
- Federal University of São Paulo — São Paulo
India · 1 center
- Aravind Eye Care System — Madurai
Identifiers
NCT: NCT07743489 · 86425