The FLuorometholone as Adjunctive MEdical Therapy for Trachomatous Trichiasis Surgery (FLAME) Trial: Study Design

Ahlam Awad Mohammed, Aida Abashawl, Sarity Dodson, Wondu Alemayehu, Alemu Gemechu, Aemero Abateneh Mengesha, Dereje Kumsa, Tony Succar, Yineng Chen, Kathleen McWilliams, Vatinee Y. Bunya, Maureen G. Maguire, Matthew J Burton, Gui-shuang Ying, John H Kempen
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Abstract

Purpose: To report the design of FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial. Design: Parallel design, double-masked, placebo-controlled clinical trial with 1:1 randomization to fluorometholone 0.1% eyedrops twice daily or placebo twice daily for four weeks in eyes undergoing trachomatous trichiasis (TT) surgery; assessing the efficacy, safety, and cost-effectiveness of fluorometholone 0.1% in preventing recurrent postoperative trichiasis.
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氟罗米松作为沙眼三联症手术的辅助药物疗法(FLAME)试验:研究设计
目的:报告氟甲孕酮作为 TT 手术辅助药物疗法(FLAME)试验的设计。设计:平行设计、双掩蔽、安慰剂对照临床试验,对接受沙眼性倒睫(TT)手术的眼睛进行1:1随机分配,使用0.1%氟米龙眼药水,每天两次或安慰剂,每天两次,为期四周;评估0.1%氟米龙在预防术后复发倒睫方面的有效性、安全性和成本效益。
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