To assess the outcome of Acanthamoeba keratitis on combination of topical Biguanides and oral Miltefosine.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- BCVA, Healing time, Number of corneal ulcers responded on medical treatment
研究概览
简要总结
Acanthamoeba keratitis is a rare but potentially devastating amoebic infection of the cornea..Currently, the management of Acanthamoeba keratitis is diamidines and biguanides .With the use of these medications, resolution is achieved in 60-70% of the cases. But it needs long treatment duration and also associated severe ocular toxicity.Miltefosine, has been approved recently by the U.S. Food and Drug Administration for Acanthamoeba keratitis as an orhan drug category. In this prospective interventional study, we will evaluate its role as a first line systemic therapy in addition to the topical biguanides in combination.
NOTE: We will perform pilot study in 10 patient and do interim analysis and based on the results we will proceed or conclude the study.
We will include all the cases based on the clinical judgement and not exclude anterior stromal keratities or less than 4mm size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with age more than 18 years 2.Microbiologically proven Acanthamoeba keratitis 3.Patients willing to participate and follow up.
排除标准
- •1.Patients with age less than 18 years 2.Pregnant and lactating females 3.Patients who are likely to be pregnant are relative contraindicated.
- •4.Patient not willing to participate and follow up 5.Patients with known allergy to Miltefosine 6.Patients with epithelial or sub epithelial keratitis with only anterior stroma involvement with less than 4 mm.
结局指标
主要结局
BCVA, Healing time, Number of corneal ulcers responded on medical treatment
时间窗: 0 week, 1 week, 2 week , 1 month, 3 month, 6 months
次要结局
- Number of patients needed glue or undergone therapeutic Penetrating keratoplasty (TPK) for worsening of infection.(It will be observed as a pilot trial of 10 patients for 6 months and later continued for 2 years. we will perform analysis of these cases after 6 months)