Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 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 II (REAGIR II) is a randomized, double-masked feasibility study. 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 smear-positive and/or culture positive typical (I.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 of worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups:
- Group 6, RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus RB-PDT
- Group 7, Sham RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham 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
- •Corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-Nocardia or Myobacteria)
- •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
- •Presence of desmetocele at recruitment
- •Non-infectious or autoimmune keratitis
- •History of corneal transplantation
- •History of intraocular surgery within the last three months*
- •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
Sham RB-PDT Plus Early Steroids
干预措施: Moxifloxacin Ophthalmic (Drug)
RB-PDT Plus Early Steroids
干预措施: Difluprednate Ophthalmic (Drug)
Sham RB-PDT Plus Early Steroids
干预措施: Difluprednate Ophthalmic (Drug)
RB-PDT Plus Early Steroids
干预措施: Moxifloxacin Ophthalmic (Drug)
RB-PDT Plus Early Steroids
干预措施: Rose Bengal (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
- Scar size(3 Weeks, 3 Months, 6 Months 12 Months)
- Scar depth(3 Weeks, 3 Months, 6 Months 12 Months)
- Best Spectacle-Corrected Visual Acuity(3 Weeks, 3 Months, 12 Months)
- Adverse Events(12 Months)