Evidence map›Paper›PMID 41539314›Full record

Trial reportThe Lancet. Global health2026

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.

John H Kempen, Aida Abashawl, Ahlam Awad Mohammed, Sarity Dodson, Wondu Alemayehu, Fangming Jin, Alemu Gemechu, Aemero Abateneh Mengesha, Dereje Adugna Kumsa, Yineng Chen and 13 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Global health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04149210 (FLuorometholone as Adjunctive MEdical Therapy for TT Surgery), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04149210 phase3completednot on this map

FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial

TypeinterventionalSponsorMassachusetts Eye and Ear InfirmaryRan2021 to 2024Enrolled2,410ConditionsTrachomatous Trichiasis (TT), Eye Diseases, Eyelid Diseases, TrachomatousArmsFluorometholone 0.1% Oph Susp, Artificial Tears
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

John H KempenDepartment 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.
Aida AbashawlBerhan Public Health and Eye Care Consultancy, Addis Ababa, Ethiopia.
Ahlam Awad MohammedDepartment 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.
Sarity DodsonFred Hollows Foundation, Addis Ababa, Ethiopia and Melbourne, VIC, Australia.
Wondu AlemayehuFred Hollows Foundation, Addis Ababa, Ethiopia and Melbourne, VIC, Australia.
Fangming JinScheie Eye Institute and Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Alemu GemechuFred Hollows Foundation, Addis Ababa, Ethiopia and Melbourne, VIC, Australia.
Aemero Abateneh MengeshaBerhan Public Health and Eye Care Consultancy, Addis Ababa, Ethiopia; Department of Ophthalmology, Bahir Dar University College of Medicine and Health Sciences, Bahir Dar, Ethiopia.
Dereje Adugna KumsaDiseases Prevention and Control Directorate, Oromia Regional Health Bureau, Addis Ababa, Ethiopia.
Yineng ChenScheie Eye Institute and Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Kathleen McWilliamsScheie Eye Institute and Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Berhanu TuluBerhan Public Health and Eye Care Consultancy, Addis Ababa, Ethiopia.
Genemo AbdelaBerhan Public Health and Eye Care Consultancy, Addis Ababa, Ethiopia.
Alemayehu MegersaFred Hollows Foundation, Addis Ababa, Ethiopia and Melbourne, VIC, Australia.
Tolossa CheruFred Hollows Foundation, Addis Ababa, Ethiopia and Melbourne, VIC, Australia.
Gadisa MohammadFred Hollows Foundation, Addis Ababa, Ethiopia and Melbourne, VIC, Australia.
Tony SuccarUSC 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.
Vatinee Y BunyaScheie Eye Institute and Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
K Davina FrickCarey Business School, Johns Hopkins University, Baltimore, ML, USA.
Maureen G MaguireScheie Eye Institute and Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Matthew J BurtonInternational 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.
Gui-Shuang YingScheie 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.
FLAME Trial Research Group

Funding

Fluorometholone as Adjunctive Therapy for Trachomatous Trichiasis SurgeryUG1EY030420 · NEI · MASSACHUSETTS EYE AND EAR INFIRMARY · PI KEMPEN, JOHN H · 2019 to 2023
$4.2M
Fluoromethelone as Adjunctive Medical Therapy for TT Surgery (FLAME) TrialUG1EY030419 · NEI · UNIVERSITY OF PENNSYLVANIA · PI YING, GUI-SHUANG · 2019 to 2023
$2.4M
NEI NIH HHS UG1 EY030419NEI NIH HHS UG1 EY030420
6 · The paper itself

Abstract

backgroundIn 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).

methodsIn 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.

findingsBetween 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.

interpretationFluorometholone twice daily for 4 weeks was safe but not efficacious or cost-effective for reducing PTT, and hence is not recommended for programmatic use.

fundingNational Eye Institute (National Institutes of Health) and AbbVie. TRANSLATIONS: For the Amharic and Oromifa translations of the abstract see Supplementary Materials section.

Indexed as

Anti-Inflammatory AgentsFluorometholoneTrachomaTrichiasisAdolescentAdultAgedDouble-Blind MethodEthiopiaFemaleHumansMaleMiddle AgedOphthalmic SolutionsTreatment OutcomeYoung AdultAnti-Inflammatory AgentsFluorometholoneOphthalmic Solutions

Identifiers

PMID41539314
PMCPMC13034013

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.