Parasitic Ulcer Treatment Trial
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
- 24
- 主要终点
- Vision
研究概览
简要总结
The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups:
- Group 1: Topical corticosteroid
- Group 2: Topical placebo
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AK on at least one of the following: culture, smear, PCR, shotgun sequencing, biopsy, or confocal microscopy
- •Ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation
排除标准
- •Evidence or history of interstitial keratitis
- •Known herpetic keratitis, as determined from history, exam, or microbiological testing
- •Known fungal keratitis, as demonstrated from corneal scrapings
- •Corneal perforation or impending corneal perforation
- •Prior therapeutic keratoplasty for acanthamoeba keratitis
- •Unwillingness or inability to follow-up
- •No light perception in the affected eye
- •Known hypertensive response to steroids
- •Corticosteroid allergy
- •Concurrent treatment with systemic corticosteroids
- •Concurrent granulomatous amoebic encephalitis
研究组 & 干预措施
Topical steroids
Participants in this arm will receive anti-amoebic therapy plus topical steroids.
干预措施: Polyhexamethylene biguanide (PHMB) (Drug)
Topical steroids
Participants in this arm will receive anti-amoebic therapy plus topical steroids.
干预措施: Topical corticosteroid (Drug)
Topical placebo
Participants in this arm will receive anti-amoebic therapy plus topical placebo.
干预措施: Polyhexamethylene biguanide (PHMB) (Drug)
Topical placebo
Participants in this arm will receive anti-amoebic therapy plus topical placebo.
干预措施: Topical placebo (Other)
结局指标
主要结局
Vision
时间窗: 6 Months
Best corrected visual acuity
次要结局
- Self-reported eye pain(2 months)
- Clinical Resolution(12 months)
- Multivariate Analysis(6 Months)
研究者
Jeremy Keenan, MD, MPH
Professor of Ophthalmology/Director of International Programs at the Proctor Foundation
University of California, San Francisco