Cross-linking for Corneal Ulcers Treatment Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Microbiological Cure on Repeat Culture
研究概览
简要总结
The primary purpose of this study is to determine if patients randomized to corneal collagen cross-linking plus medical therapy will have a lower prevalence of positive bacterial or fungal cultures immediately after the procedure than patients who received medical therapy alone.
The secondary purpose of this study is to determine if patients randomized to corneal collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who receive medical therapy alone.
详细描述
The proposed study is a randomized controlled trial to determine whether collagen cross-linking improves outcomes in microbial keratitis. Patients presenting to the Aravind Eye Hospitals in Madurai, India for treatment of microbial keratitis will be recruited for the proposed study. Approximately 266 patients will be enrolled in the study. Subjects presenting with bacterial keratitis will be randomized to receive medical therapy plus corneal collagen cross-linking at presentation or to receive medical therapy alone. All subjects with bacterial ulcers will receive standard topical antibiotic medications as required after the procedure.
Subjects with fungal keratitis will be randomized into one of four groups:
- collagen cross-linking + amphotericin;
- collagen cross-linking + natamycin;
- amphotericin alone;
- natamycin alone.
All study subjects will be followed for 12 months to evaluate response to treatment.
Investigators from the University of California, San Francisco (UCSF) will assist Aravind Eye Hospital with the study design, implementation, and analysis of the research, and will help fund the study. The investigators plan to visit Aravind to help with the study implementation. UCSF will play an important role in this study by assisting with the study design, implementation, analysis, and funding.
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, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fungal ulcer cross-linking plus amphotericin
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
干预措施: Anti Fungal Drug (Drug)
Bacterial ulcer cross-linking
Standard of care topical treatment for bacterial ulcer plus cross-linking
干预措施: Corneal Cross-linking (Procedure)
Bacterial ulcer control
Standard of care topical treatment for bacterial ulcer
干预措施: Corneal Cross-linking (Procedure)
Fungal ulcer cross-linking plus natamycin
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
干预措施: Corneal Cross-linking (Procedure)
Fungal ulcer cross-linking plus natamycin
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
干预措施: Anti Fungal Drug (Drug)
Fungal ulcer control with natamycin
Standard of care topical treatment for fungal ulcer with natamycin
干预措施: Corneal Cross-linking (Procedure)
Fungal ulcer control with natamycin
Standard of care topical treatment for fungal ulcer with natamycin
干预措施: Anti Fungal Drug (Drug)
Fungal ulcer cross-linking plus amphotericin
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
干预措施: Corneal Cross-linking (Procedure)
Fungal ulcer control with amphotericin
Standard of care topical treatment for fungal ulcer with amphotericin
干预措施: Corneal Cross-linking (Procedure)
Fungal ulcer control with amphotericin
Standard of care topical treatment for fungal ulcer with amphotericin
干预措施: Anti Fungal Drug (Drug)
结局指标
主要结局
Microbiological Cure on Repeat Culture
时间窗: 4 to 24 hours after enrollment
Corneal scraping of the ulcer will be performed and directly inoculated on to sheep's blood agar, chocolate agar, potato dextrose agar or Sabouraud's agar for bacterial and fungal culture. Microbiological cure is defined as no growth of bacteria or fungus on these media.
次要结局
- Best Spectacle-corrected Visual Acuity(3 months)
- Scar Size(3 months)
- Adverse Events Including Rate of Perforation/Need for Therapeutic Penetrating Keratoplasty(3 months)