Mohammed Ahlam Awad, Abashawl Aida, Dodson Sarity, Alemayehu Wondu, Gemechu Alemu, Mengesha Aemero Abateneh, Kumsa Dereje, Succar Tony, Chen Yineng, McWilliams Kathleen, Bunya Vatinee Y, Maguire Maureen G, Burton Matthew J, Ying Gui-Shuang, Kempen John H
medRxiv. 2024 Jul 7:2024.06.26.24308549. doi: 10.1101/2024.06.26.24308549.
To report the design of FL uorometholone as A djunctive ME dical Therapy for TT Surgery (FLAME) Trial.
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.
Up to 2500 eligible persons with trachomatous trichiasis (TT) undergoing lid rotation surgery will be enrolled in 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 surgeon, which simultaneously stratifies by the district. The study visits are at baseline/enrollment, at four-week post-enrollment, six months, and one year (study exit). The primary outcome is cumulative one-year postoperative TT (PTT) incidence, defined as: ≥1 lashes touching the globe, evidence of epilation, and/or repeat TT surgery. Secondary postoperative outcomes include number of trichiatic lashes, location thereof (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 baseline, eyelid contour abnormality, granuloma, eyelid closure defect, and 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. Trial Registration: ClinicalTrials.gov # NCT04149210.
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，将接受沙眼性睑内翻（TT）手术的眼睛以1:1随机分为每日两次使用0.1%氟米龙滴眼液或每日两次使用安慰剂，持续四周；评估0.1%氟米龙在预防术后复发性睑内翻方面的疗效、安全性和成本效益。
在埃塞俄比亚吉马地区，将招募多达2500名符合条件的患有沙眼性睑内翻（TT）并接受睑旋转手术的患者。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均对治疗分配情况不知情。随机分组按外科医生分层，同时也按地区分层。研究访视时间点为基线/入组时、入组后四周、六个月和一年（研究结束）。主要结局是术后一年累计睑内翻（PTT）发生率，定义为：≥1根睫毛触及眼球、有拔毛迹象和/或再次进行睑内翻手术。术后次要结局包括倒睫睫毛数量、其位置（是否触及角膜）、术后拔毛迹象、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/术后辅助治疗与睑内翻手术联合应用的疗效、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。试验注册：ClinicalTrials.gov # NCT04149210 。
