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 : 2024-12-10 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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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.