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

IF 1.7 4区医学 Q3 OPHTHALMOLOGY Ophthalmic epidemiology Pub Date : 2024-12-01 Epub Date: 2024-12-10 DOI:10.1080/09286586.2024.2415052

Ahlam Awad Mohammed, Aida Abashawl, Sarity Dodson, Wondu Alemayehu, Alemu Gemechu, Aemero Abateneh, 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% eye drops twice daily or placebo twice daily for 4 weeks in eyes undergoing trachomatous trichiasis (TT) surgery for assessing the efficacy, safety, and cost-effectiveness of fluorometholone 0.1% in preventing recurrent postoperative trichiasis (PTT).

Methods: Up to 2500 eligible persons with trachomatous trichiasis undergoing lid rotation surgery were enrolled in the Jimma zone, Ethiopia. Participants, surgeons, study field staff, and study supervisors leading operational aspects of the trial are masked to treatment assignment. Randomization is stratified by the surgeon and is simultaneously stratified by the district. Study visits (in addition to programmatic follow-ups) are at the baseline/enrollment, at four-week post-enrollment, and after 6 months and 1 year. The primary outcome is cumulative one-year PTT incidence, defined as: ≥1 lashes touching the globe, evidence of epilation, and/or repeat TT surgery. Secondary postoperative outcomes include the number of trichiatic lashes, location (touching the cornea or not), evidence of post-operative epilation, entropion, changes in corneal opacity, IOP elevation, need for cataract surgery, visual acuity change from the baseline, eyelid contour abnormality, granuloma, eyelid closure defect, and the occurrence of adverse events. Health economic analyses center on calculating the incremental cost per case of PTT avoided by fluorometholone treatment.

Conclusion: The FLAME Trial is designed to provide evidence of the efficacy, safety, and cost-effectiveness of adjunctive topical peri-/postoperative fluorometholone 0.1% therapy with trichiasis surgery, which is hypothesized to reduce the risk of recurrent trichiasis while being acceptably safe.

Clinical trial registration: https://www.clinicaltrials.gov/study/NCT04149210.

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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：报道氟美洛酮作为TT手术辅助药物治疗（FLAME）试验的设计。设计：平行设计，双盲，安慰剂对照临床试验，1:1随机分组，0.1%氟美洛酮滴眼液每天两次或安慰剂每天两次，持续4周，用于评估0.1%氟美洛酮预防术后反复倒睫（PTT）的疗效、安全性和成本效益。方法：在埃塞俄比亚的Jimma地区招募了2500名接受眼睑旋转手术的沙眼倒睫患者。参与者、外科医生、研究现场工作人员和领导试验操作方面的研究主管对治疗分配不知情。随机化由外科医生分层，同时由地区分层。研究访问（除计划性随访外）分别在基线/入组、入组后四周、6个月和1年后进行。主要终点是一年PTT的累计发生率，定义为：≥1个睫毛接触眼球，脱毛的证据，和/或重复TT手术。术后次要结局包括睫状睫毛数量、位置（是否接触角膜）、术后脱毛、内翻、角膜混浊变化、IOP升高、是否需要白内障手术、基线视力变化、眼睑轮廓异常、肉芽肿、眼睑闭合缺损、不良事件发生等。卫生经济分析的重点是计算氟美酮治疗避免的每例PTT的增量成本。结论：FLAME试验旨在提供证据，证明0.1%氟美洛酮辅助倒睫手术围/术后局部治疗的有效性、安全性和成本效益，假设该治疗可以降低倒睫复发的风险，同时具有可接受的安全性。临床试验注册：https://www.clinicaltrials.gov/study/NCT04149210。

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来源期刊

Ophthalmic epidemiology 医学-眼科学

CiteScore

3.70

自引率

5.60%

发文量

审稿时长

6-12 weeks

期刊介绍： Ophthalmic Epidemiology is dedicated to the publication of original research into eye and vision health in the fields of epidemiology, public health and the prevention of blindness. Ophthalmic Epidemiology publishes editorials, original research reports, systematic reviews and meta-analysis articles, brief communications and letters to the editor on all subjects related to ophthalmic epidemiology. A broad range of topics is suitable, such as: evaluating the risk of ocular diseases, general and specific study designs, screening program implementation and evaluation, eye health care access, delivery and outcomes, therapeutic efficacy or effectiveness, disease prognosis and quality of life, cost-benefit analysis, biostatistical theory and risk factor analysis. We are looking to expand our engagement with reports of international interest, including those regarding problems affecting developing countries, although reports from all over the world potentially are suitable. Clinical case reports, small case series (not enough for a cohort analysis) articles and animal research reports are not appropriate for this journal.