Evidence map›Paper›PMID 39656933›Full record

Trial reportOphthalmic epidemiology2024

The FLuorometholone as Adjunctive MEdical Therapy for Trachomatous Trichiasis Surgery (FLAME) Trial: Study Design.

Ahlam Awad Mohammed, Aida Abashawl, Sarity Dodson, Wondu Alemayehu, Alemu Gemechu, Aemero Abateneh, Dereje Kumsa, Tony Succar, Yineng Chen, Kathleen McWilliams and 6 more

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

Trial report in Ophthalmic epidemiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04149210 (FLuorometholone as Adjunctive MEdical Therapy for TT Surgery), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Trial
  2. Trial
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Ahlam Awad MohammedDepartment of Ophthalmology and Schepens Eye Research Institute, Massachusetts Eye and Ear Infirmary, Boston, MA, USA.ORCID 0009-0005-2897-0740
Aida AbashawlBerhan Public Health and Eye Care Consultancy, Addis Ababa, Ethiopia.
Sarity DodsonFred Hollows Foundation, Melbourne, Australia.
Wondu AlemayehuFred Hollows Foundation, Melbourne, Australia.
Alemu GemechuFred Hollows Foundation, Addis Ababa, Ethiopia.
Aemero AbatenehBerhan Public Health and Eye Care Consultancy, Addis Ababa, Ethiopia.
Dereje KumsaDiseases Prevention and Control Directorate, Oromia Regional Health Bureau, Addis Ababa, Ethiopia.
Tony SuccarMassachusetts Eye and Ear Infirmary and Harvard Medical School, Boston, MA, USA.
Yineng ChenDepartment of Ophthalmology, Scheie Eye Institute, Philadelphia, PA, USA.
Kathleen McWilliamsDepartment of Ophthalmology, Scheie Eye Institute, Philadelphia, PA, USA.
Vatinee Y BunyaDepartment of Ophthalmology, Scheie Eye Institute, Philadelphia, PA, USA.
Maureen G MaguireDepartment of Ophthalmology, Scheie Eye Institute, Philadelphia, PA, USA.
Matthew J BurtonInternational Center for Eye Health, London School of Hygiene & Tropical Medicine, London, UK.
Gui-Shuang YingDepartment of Ophthalmology, Scheie Eye Institute, Philadelphia, PA, USA.
John H KempenDepartment of Ophthalmology and Schepens Eye Research Institute, Massachusetts Eye and Ear Infirmary, Boston, MA, USA.ORCID 0000-0002-2967-4792
FLuorometholone as Adjunctive MEdical Therapy for Trachomatous Trichiasis Surgery (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

purposeTo report the design of FLuorometholone as Adjunctive MEdical therapy for TT surgery (FLAME) trial.

designParallel 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).

methodsUp 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.

conclusionThe 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 registrationhttps://www.clinicaltrials.gov/study/NCT04149210.

Indexed as

FluorometholoneTrachomaTrichiasisAdultChemotherapy, AdjuvantCost-Benefit AnalysisDouble-Blind MethodEthiopiaEyelashesFemaleHumansMaleMiddle AgedOphthalmic SolutionsOphthalmologic Surgical ProceduresPostoperative ComplicationsFluorometholoneOphthalmic SolutionsFluorometholonerecurrencetrachomatous trichiasis

Identifiers

PMID39656933
PMCPMC13352201

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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.