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NCT07743489
RB-PDT for Fusarium Keratitis: The LUMIERE Study
Conditions: Fusarium Keratitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 434
Sponsor: Stanford University
Location: Stanford University Palo Alto California
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).
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 desmestocele 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
Source: ClinicalTrials.gov (NCT07743489). StuddyBuddy aggregates publicly available trial information.