Fluoromethelone as Adjunctive Medical Therapy for TT Surgery (FLAME) Trial

沙眼是世界范围内导致失明的主要传染病。沙眼性倒睫(TT)，a 慢性沙眼所致瘢痕形成的并发症是导致 沙眼致盲。目前，缓解倒睫的手术是一项关键的全球计划 预防沙眼失明的策略。不幸的是，令人不快的高复发率 (约20-30%)在TT手术后。手术本身和/或沙眼引起的炎症 发病过程可能是TT复发的原因之一。我们的初步审判发现反- 炎症性氟米松0.1%滴眼液与一年TT风险降低约1/3相关 复发率高于安慰剂组，且0.1%的氟米松副作用最小。 氟罗米松作为TT手术的辅助药物治疗(FLAMP)试验是一项双重试验。 蒙面安慰剂对照随机临床试验，以评估疗效、安全性和成本- 0.1%氟米松滴眼液辅助治疗甲状腺癌的疗效观察 埃塞俄比亚。 数据中心(DC)将与研究主席办公室、外地密切合作 埃塞俄比亚协调中心(FCC)、执行委员会(EC)和数据安全 监督委员会(DSMC)，以确保试验的成功。区议会在这项试验中的角色是 在试验的设计、实施和维护方面提供领导和专业知识 质量数据管理系统、统计分析和试验结果的公布。 这项试验的结果将提供一级证据，证明0.1%氟米松滴眼液 应该被推荐为一种在编程上有用的策略，广泛应用于 沙眼失明缓解计划。证明其有效性、安全性及其成本效益 0.1%的氟米松滴眼液将为改善TT和TT的治疗提供机会 在全球范围内减少TT造成的视力损害和失明。

Trachoma, the leading infectious cause of blindness worldwide. Trachomatous trichiasis (TT), a complication of the chronic trachoma-induced cicatrization, is a key mechanism leading to blindness from trachoma. Currently, surgery to relieve trichiasis is a key global programmatic strategy to prevent trachoma blindness. Unfortunately, an undesirably high recurrence rate (about 20-30%) following TT surgery. Inflammation due to surgery itself and/or the trachomatous pathogenic process likely contributes to TT recurrence. Our preliminary trial found that anti- inflammatory fluorometholone 0.1% eyedrops was associated with ~1/3 lower risk of one-year TT recurrence than the placebo group, and fluorometholone 0.1% had minimal side effects. The FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial is a double- masked placebo-controlled randomized clinical trial to evaluate the efficacy, safety and cost- effectiveness of fluorometholone 0.1% eyedrops as an adjunctive therapy for TT surgery in Ethiopia. The Data Center (DC) will collaborate closely with the Study Chairman's Office, the Field Coordinating Center (FCC) in Ethiopia, the Executive Committee (EC), and the Data Safety Monitoring Committee (DSMC) to ensure the success of the trial. The DC's role for this trial is to provide leadership and expertise on design of trials, implementation and maintenance of high quality data management system, statistical analysis and publication of trial findings. Results of this trial will provide Level 1 evidence as to whether fluorometholone 0.1% eyedrops should be recommended as a programmatically useful strategy for widespread adoption into trachoma blindness alleviation programs. Proof of the efficacy, safety and its cost-effectiveness of fluorometholone 0.1% eyedrops would provide an opportunity to improve the treatment of TT and reduce the visual impairment and the blindness from TT globally.