Mohammed Ahlam Awad, Abashawl Aida, Dodson Sarity, Alemayehu Wondu, Gemechu Alemu, Abateneh Aemero, Kumsa Dereje, Succar Tony, Chen Yineng, McWilliams Kathleen, Bunya Vatinee Y, Maguire Maureen G, Burton Matthew J, Ying Gui-Shuang, Kempen John H
Department of Ophthalmology and Schepens Eye Research Institute, Massachusetts Eye and Ear Infirmary, Boston, MA, USA.
Berhan Public Health and Eye Care Consultancy, Addis Ababa, Ethiopia.
Ophthalmic Epidemiol. 2024 Dec;31(6):611-619. doi: 10.1080/09286586.2024.2415052. Epub 2024 Dec 10.
To report the design of FLuorometholone as Adjunctive MEdical therapy for TT surgery (FLAME) trial.
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).
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.
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.
报告氟米龙作为睑内翻手术辅助药物治疗（FLAME）试验的设计。
平行设计、双盲、安慰剂对照临床试验，将1:1随机分配至0.1%氟米龙滴眼液每日两次或安慰剂每日两次，持续4周，用于接受沙眼性睑内翻（TT）手术的眼睛，以评估0.1%氟米龙预防术后复发性睑内翻（PTT）的疗效、安全性和成本效益。
在埃塞俄比亚吉马地区，招募了多达2500名符合条件的沙眼性睑内翻患者接受睑旋转手术。参与者、外科医生、研究现场工作人员以及负责试验操作方面的研究监督员对治疗分配情况不知情。随机分组按外科医生分层，同时按地区分层。研究访视（除了项目随访外）在基线/入组时、入组后4周、6个月和1年后进行。主要结局是累积一年的PTT发生率，定义为：≥1根睫毛触及眼球、脱毛证据和/或再次进行TT手术。术后次要结局包括倒睫睫毛数量、位置（是否触及角膜）、术后脱毛证据、睑内翻、角膜混浊变化、眼压升高、白内障手术需求、与基线相比的视力变化、眼睑轮廓异常、肉芽肿、眼睑闭合缺陷以及不良事件的发生情况。卫生经济学分析集中于计算氟米龙治疗避免每例PTT的增量成本。
FLAME试验旨在提供0.1%氟米龙局部围手术期/术后辅助治疗睑内翻手术的疗效、安全性和成本效益的证据，据推测该治疗可降低复发性睑内翻风险且安全性可接受。
