Parasitic Ulcer Treatment Trial (PUTT)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Improved 6 month best corrected visual acuity and hasten the time for acanthamoeba keratitis clinical resolution in the steroid group
研究概览
简要总结
Acanthamoeba Keratitis (AK) is an extremely painful, blinding infection requiring long treatment courses. In India, higher incidence of AK has been observed among farmers. Most common mode of injury is mud and contaminated water exposure. The best way to treat AK is entirely unclear. Even with successful antiamoebic treatment, many eyes develop corneal inflammation leading to corneal scarring and poor vision. Use of topical corticosteroids for the treatment of AK is unclear. In this proposal we seek to establish the safety and efficacy of topical corticosteroids when used alongside anti-amoebic agents and to determine whether any host or pathogen factors can be used to predict the clinical response to steroid therapy by doing Metagenomic deep sequencing (MDS). Aravind Eye Hospital, Madurai, and Proctor Foundation, University of California-San Fransisco, will work in collaboration to better understand these mechanisms and help improve the outcomes of AK patients in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Smear culture PCR Confocal positive Acanthamoeba keratitis b) Acanthamoeba keratitis patients treated with antiamoebic therapy and have corneal episcleral or anterior chamber inflammation at 4 weeks c) Appropriate written and informed consent.
排除标准
- •a) No consent b) Fungal or Herpetic keratitis c) Corneal perforation and impending corneal perforation d) Prior keratoplasty e) Visual acuity of No light perception in the affected eye f) Debilitated patient g) Patients on systemic corticosteroids h) Corticosteroids allergy i) Pregnant mothers j) Steroids responders.
结局指标
主要结局
Improved 6 month best corrected visual acuity and hasten the time for acanthamoeba keratitis clinical resolution in the steroid group
时间窗: 4 years
次要结局
- To study the contribution of organism virulence factors and host factors for severe inflammatory outcomes by metagenomic deep sequencing(4 years)
研究者
Dr N Venkatesh Prajna
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology