Fluorometholone 0.1% as Ancillary Therapy for Trachomatous Trichiasis Surgery: Randomized Clinical Trial.
Journal
American journal of ophthalmology
ISSN: 1879-1891
Titre abrégé: Am J Ophthalmol
Pays: United States
ID NLM: 0370500
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
27
08
2018
revised:
12
09
2018
accepted:
17
09
2018
pubmed:
30
9
2018
medline:
18
10
2019
entrez:
30
9
2018
Statut:
ppublish
Résumé
To assess the hypothesis that fluorometholone 0.1% eye drops are safe and effective as adjunctive therapy for trachomatous trichiasis (TT) surgery; determining the most promising dose. Randomized, placebo-controlled, double-masked parallel dose-ranging clinical trial. Patients undergoing upper lid TT surgery at a rural Ethiopian hospital were randomized to fluorometholone 0.1% twice daily for 4 weeks, 4 times daily for 4 weeks, 4 times daily for 8 weeks, or matching frequency placebo in a 3:1:3:1:3:1 ratio for 1 eye. Randomization was stratified by TT severity (1-4 vs ≥5 lashes touching the globe). Safety outcomes (intraocular pressure [IOP] elevation, cataract, and other dose-limiting toxicities) and postoperative TT incidence were assessed over 1 year. Subjects randomized were 39:13:39:13:38:13 in the respective groups, and 1 subject in the 8-weeks fluorometholone group was withdrawn. Of 154 subjects, 148 (96.1%) completed 1 year's follow-up. Among 76 eyes receiving fluorometholone 4 times daily, 1 developed IOP elevation ≥ 30 mm Hg (to 37 mm Hg) and 1 had an allergic reaction attributed to the study drug; each resolved upon drug cessation without sequelae. No cataract or other dose-limiting toxicity events occurred. Postoperative TT within 1 year occurred in 29.3% of placebo eyes vs 17.7%, 19.6%, and 23.2% among the respective fluorometholone groups (P = .29 comparing placebo vs all active treatments combined). The results suggest fluorometholone 0.1% is likely to be safe and efficacious to reduce postoperative TT following TT surgery, and 1 drop twice daily for 4 weeks is the most promising dose. Confirmation in a full-scale clinical trial is needed before programmatic implementation.
Identifiants
pubmed: 30267699
pii: S0002-9394(18)30537-3
doi: 10.1016/j.ajo.2018.09.017
pmc: PMC7453666
mid: NIHMS1512268
pii:
doi:
Substances chimiques
Anti-Inflammatory Agents
0
Fluorometholone
SV0CSG527L
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
145-155Subventions
Organisme : NEI NIH HHS
ID : P30 EY001583
Pays : United States
Informations de copyright
Copyright © 2018 Elsevier Inc. All rights reserved.
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