Light for Ulcer Management by Infection Elimination and Resistance Enhancement (LUMIERE)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 434
- 试验地点
- 4
- 主要终点
- BSCVA at 3 months
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The patient, physicians, microbiologist, and refractionist performing the best spectacle-corrected visual acuity (BSCVA) assessment will be masked to the treatment group. Due to the nature of the intervention, the surgeon and technician performing cross-linking will not be masked. All study medications and placebo will be labelled identically to ensure adequate masking of study physicians and patients.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 2: Sham RB-PDT
Group 2 participants will receive natamycin 5%/Amphotericin B 0.15% plus sham RB-PDT
干预措施: Sham RB-PDT (Drug)
Group 1: RB-PDT
Group 1 participants will receive natamycin 5%/Amphotericin B 0.15% plus RB-PDT
干预措施: Rose Bengal Photodynamic Therapy (Drug)
结局指标
主要结局
BSCVA at 3 months
时间窗: 3 months post-op
Best spectacle-corrected visual acuity measured in logMAR at 3 month follow-up visit
次要结局
未报告次要终点
研究者
Jennifer Rose-Nussbaumer
Professor
Stanford University