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

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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引用次数: 0

摘要

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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The FLuorometholone as Adjunctive MEdical Therapy for Trachomatous Trichiasis Surgery (FLAME) Trial: Study Design
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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