Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Best Spectacle-Corrected Visual Acuity
研究概览
简要总结
Rose Bengal Electromagnetic Activation with Green light for Infection Reduction (REAGIR ) is an international, randomized, doubled masked, clinical trial. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose Bengal (RB-PDT).
Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with either smear or culture positive fungal or acanthamoeba keratitis or smear and culture negative corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups:
Group 4, Sham RB-PDT: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Group 5, RB-PDT: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 smear or culture positive fungal or acanthamoeba ulcer; smear or culture negative ulcer; or any atypical bacteria (such as Nocardia)
- •Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) or worse
- •Corneal thickness ≥350 µm, as measured on AS-OCT
- •Age over 18 years
- •Basic understanding of the study as determined by the physician
- •Commitment to return for follow up visits
排除标准
- •Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthamoeba on gram stain)
- •Impending or frank perforation at recruitment
- •Involvement of sclera at presentation
- •Non-infectious or autoimmune keratitis
- •History of corneal transplantation
- •History of intraocular surgery within last three months
- •Pinhole visual acuity worse than 20/200 in the unaffected eye
- •Participants who are decisionally and/or cognitively impaired
- •Presence of demestocele at recruitment
研究组 & 干预措施
Standard Therapy
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
干预措施: Chlorhexidine Gluconate (Drug)
Standard Therapy
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
干预措施: Natamycin (Drug)
Cross-Linking with rose Bengal (RB-PDT)
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
干预措施: Chlorhexidine Gluconate (Drug)
Cross-Linking with rose Bengal (RB-PDT)
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
干预措施: Natamycin (Drug)
Standard Therapy
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
干预措施: Placebo (Other)
Cross-Linking with rose Bengal (RB-PDT)
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
干预措施: Moxifloxacin Ophthalmic (Drug)
Cross-Linking with rose Bengal (RB-PDT)
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
干预措施: Rose Bengal (Drug)
Standard Therapy
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
干预措施: Moxifloxacin Ophthalmic (Drug)
结局指标
主要结局
Best Spectacle-Corrected Visual Acuity
时间窗: 6 Months
Best Spectacle-Corrected Visual Acuity
次要结局
- Best Spectacle-Corrected Visual Acuity(3 Weeks, 3 Months, 12 Months)
- Scar Depth(3 Weeks, 3 Months, 6 Months 12 Months)
- Scar Size(3 Weeks, 3 Months, 6 Months 12 Months)
- Adverse Events(12 Months)