Academic Journal
Evaluation of fluorometholone as adjunctive medical therapy for trachomatous trichiasis surgery (FLAME): a parallel, double-blind, randomised controlled field trial in the Jimma Zone, Ethiopia.
| Τίτλος: | Evaluation of fluorometholone as adjunctive medical therapy for trachomatous trichiasis surgery (FLAME): a parallel, double-blind, randomised controlled field trial in the Jimma Zone, Ethiopia. |
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| Συγγραφείς: | Kempen JH; Department of Ophthalmology and Schepens Eye Research Institute, Massachusetts Eye and Ear Infirmary, Boston, MA, USA; Department of Ophthalmology and Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA; Sight for Souls, Bellevue, WA, USA; MCM Eye Unit, MyungSung Christian Medical Center General Hospital and MyungSung Medical College, Addis Ababa, Ethiopia; Department of Ophthalmology, Addis Ababa University School of Medicine, Addis Ababa, Ethiopia. Electronic address: john_kempen@meei.harvard.edu., Abashawl A; Berhan Public Health and Eye Care Consultancy, Addis Ababa, Ethiopia., Mohammed AA; 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., Dodson S; Fred Hollows Foundation, Addis Ababa, Ethiopia and Melbourne, VIC, Australia., Alemayehu W; Fred Hollows Foundation, Addis Ababa, Ethiopia and Melbourne, VIC, Australia., Jin F; Scheie Eye Institute and Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Gemechu A; Fred Hollows Foundation, Addis Ababa, Ethiopia and Melbourne, VIC, Australia., Mengesha AA; Berhan Public Health and Eye Care Consultancy, Addis Ababa, Ethiopia; Department of Ophthalmology, Bahir Dar University College of Medicine and Health Sciences, Bahir Dar, Ethiopia., Kumsa DA; Diseases Prevention and Control Directorate, Oromia Regional Health Bureau, Addis Ababa, Ethiopia., Chen Y; Scheie Eye Institute and Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., McWilliams K; Scheie Eye Institute and Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Tulu B; Berhan Public Health and Eye Care Consultancy, Addis Ababa, Ethiopia., Abdela G; Berhan Public Health and Eye Care Consultancy, Addis Ababa, Ethiopia., Megersa A; Fred Hollows Foundation, Addis Ababa, Ethiopia and Melbourne, VIC, Australia., Cheru T; Fred Hollows Foundation, Addis Ababa, Ethiopia and Melbourne, VIC, Australia., Mohammad G; Fred Hollows Foundation, Addis Ababa, Ethiopia and Melbourne, VIC, Australia., Succar T; USC Mann School of Pharmacy, Department of Regulatory and Quality Sciences, University of Southern California, Los Angeles, CA, USA; Department of Ophthalmology, University of Sydney, Sydney, NSW, Australia., Bunya VY; Scheie Eye Institute and Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Frick KD; Carey Business School, Johns Hopkins University, Baltimore, ML, USA., Maguire MG; Scheie Eye Institute and Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Burton MJ; International Centre for Eye Health, London School of Hygiene & Tropical Medicine, London, UK; National Institute for Health Research Biomedical Research, Moorfields Eye Hospital NHS Foundation Trust and University College London Institute of Ophthalmology, London, UK., Ying GS; Scheie Eye Institute and Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. |
| Συλλογικό Έργο: | FLAME Trial Research Group |
| Πηγή: | The Lancet. Global health [Lancet Glob Health] 2026 Mar; Vol. 14 (3), pp. e395-e406. Date of Electronic Publication: 2026 Jan 12. |
| Τύπος έκδοσης: | Journal Article; Randomized Controlled Trial |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Elsevier Ltd Country of Publication: England NLM ID: 101613665 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2214-109X (Electronic) Linking ISSN: 2214109X NLM ISO Abbreviation: Lancet Glob Health Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [England] : Elsevier Ltd. 2013- |
| Ιατρικοί όροι (MeSH): | Trichiasis*/surgery , Trichiasis*/drug therapy , Trachoma*/drug therapy , Trachoma*/surgery , Trachoma*/complications , Fluorometholone*/therapeutic use , Fluorometholone*/administration & dosage , Anti-Inflammatory Agents*/therapeutic use, Ophthalmic Solutions/therapeutic use ; Humans ; Double-Blind Method ; Female ; Male ; Ethiopia ; Adult ; Middle Aged ; Young Adult ; Adolescent ; Aged ; Treatment Outcome |
| Περίληψη: | Background: In trachoma, trachomatous trichiasis mediates visual impairment. Trachomatous trichiasis surgery has an unacceptably high relapse incidence. We hypothesised that anti-inflammatory therapy with fluorometholone 0·1% suspension (hereafter fluorometholone) eyedrops perioperatively twice daily for 28 days would safely, efficaciously, and cost-effectively reduce postoperative trachomatous trichiasis relapse (PTT). Methods: In this randomised, parallel, placebo-controlled trial, we compared placebo (artificial tears) with fluorometholone for eyes undergoing trachomatous trichiasis surgery in participants aged 15 years and older at rural health centres and post sites in the Jimma zone, Ethiopia. Participants were randomly allocated (1:1) to either placebo or fluorometholone. Treatment randomisation was stratified and blocked by surgeon. Participants, surgeons, and outcome assessors were masked to treatment assignment. Outcomes were evaluated at 4 weeks, 6 months, and 12 months postoperatively. The primary outcome was cumulative 12-month incidence of PTT, defined as any of: one or more lashes touching the globe; evidence of epilation; or occurrence of repeat trachomatous trichiasis surgery. This study is registered with ClinicalTrials.gov, NCT04149210. Findings: Between Aug 19, 2021, and Nov 30, 2024, 2410 participants (1692 [70·2%] self-reported as female and 718 [29·8%] as male; 3235 eyes) were recruited. 1204 participants were randomly allocated to fluorometholone and 1206 to placebo. 823 (34·1%) participants had bilateral trachomatous trichiasis surgery. Baseline treatment group characteristics were similar; 1180 (98·0%) participants in the fluorometholone group and 1181 (97·9%) in the placebo group were evaluated at the 12-month timepoint. In the intention-to-treat analysis, the cumulative incidences of PTT during 12 months of follow-up were 218 (13·4%) of 1625 eyes in the placebo group and 213 (13·4%) of 1593 eyes in the fluorometholone group (95% CI for difference -2% to 2%). Prespecified secondary efficacy and safety outcomes were not statistically different between groups (all p≥0·10). The incidence of adverse events attributed to study treatment was nine (0·7%) in the placebo group and four (0·3%) in the fluorometholone group (p=0·17); satisfaction with surgery (satisfied or very satisfied) was recorded for 3156 (99·7%) of 3167 eyes. Health economic considerations did not favour programmatic use of fluorometholone given its inefficacy. Interpretation: Fluorometholone twice daily for 4 weeks was safe but not efficacious or cost-effective for reducing PTT, and hence is not recommended for programmatic use. Funding: National Eye Institute (National Institutes of Health) and AbbVie. Translations: For the Amharic and Oromifa translations of the abstract see Supplementary Materials section. (Copyright © 2026 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.) |
| Competing Interests: | Declaration of interests JHK reports stock ownership in startup companies Betaliq and Tarsier. All other authors declare no competing interests. |
| Σχόλια: | Erratum in: Lancet Glob Health. 2026 Aug 7:104071. doi: 10.1016/j.langlo.2026.104071.. (PMID: 42575117) |
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| Grant Information: | UG1 EY030419 United States EY NEI NIH HHS; UG1 EY030420 United States EY NEI NIH HHS |
| Molecular Sequence: | ClinicalTrials.gov NCT04149210 |
| Substance Nomenclature: | SV0CSG527L (Fluorometholone) 0 (Anti-Inflammatory Agents) 0 (Ophthalmic Solutions) |
| Entry Date(s): | Date Created: 20260115 Date Completed: 20260219 Latest Revision: 20260813 |
| Update Code: | 20260813 |
| PubMed Central ID: | PMC13034013 |
| DOI: | 10.1016/S2214-109X(25)00493-0 |
| PMID: | 41539314 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 2214-109X |
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| DOI: | 10.1016/S2214-109X(25)00493-0 |