Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Culture Positivity at Day 3 Using Potassium Hydroxide (KOH) Wet Mount to Test for Fungus
研究概览
简要总结
Mycotic Antimicrobial Localized Injection (MALIN) is a randomized, masked, two-arm clinical trial investigating intrastromal voriconazole in the treatment of fungal corneal ulcers. There is currently little evidence to guide the treatment of fungal keratitis beyond topical anti-fungal drops, though intrastromal voriconazole and oral antifungal treatments are used as well. This study will provide evidence to guide the treatment of fungal keratitis in the future. The purpose of this study is to determine differences in microbiological cure for 3-day repeat cultures between different antifungal treatments. For this study, there will be 1:1 randomization to one of these two treatment groups: 1) topical natamycin plus intrastromal voriconazole injection or 2) topical natamycin alone.
详细描述
The proposed study is a randomized controlled trial to determine whether intrastromal voriconazole improves outcomes in fungal keratitis. Patients presenting to the Aravind Eye Hospitals in Pondicherry, India for treatment of fungal keratitis will be recruited for the proposed study. Approximately 70 patients will be enrolled in the study. Subjects presenting with fungal keratitis will be randomized to receive topical natamycin plus intrastromal voriconazole or to receive topical natamycin alone. Subjects may also receive oral antifungals after day 3 at the discretion of the treating clinician. All study subjects will be followed for 3 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 will 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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe corneal ulcer that is smear positive for filamentous fungus
- •Pinhole visual acuity worse than 20/70 in affected eye
- •Basic understanding of the study as determined by the physician
- •Commitment to return for follow up visits
排除标准
- •Gram stain positive for bacteria or evidence of other concomitant infection (i.e. herpes, acanthamoeba)
- •Impending or frank perforation at recruitment
- •Involvement of sclera at presentation
- •Non-infectious or autoimmune keratitis
- •History of corneal transplantation or recent intraocular surgery
- •No light perception in the affected eye
- •Pinhole visual acuity worse than 20/200 in the unaffected eye
- •Pregnant women
- •Participants who are decisionally and/or cognitively impaired
研究组 & 干预措施
Intrastromal voriconazole plus natamycin
Intrastromal voriconazole plus standard of care topical treatment for fungal keratitis
干预措施: Intrastromal voriconazole (Drug)
Intrastromal voriconazole plus natamycin
Intrastromal voriconazole plus standard of care topical treatment for fungal keratitis
干预措施: Natamycin (Drug)
Natamycin alone
Standard of care topical treatment for fungal keratitis
干预措施: Natamycin (Drug)
结局指标
主要结局
Culture Positivity at Day 3 Using Potassium Hydroxide (KOH) Wet Mount to Test for Fungus
时间窗: 3 days
Number of of participants with positive fungal cultures at 3 days
次要结局
- Best Spectacle-corrected Visual Acuity, as Measured by a Refractionist(3 weeks and 3 months)
- Scar Size(3 weeks and 3 months)
- Number of Participants With Scar Depth at the Anterior Third, Middle Third, and Posterior Third of the Cornea(3 weeks and 3 months)