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Accepted (AM)Open Access (License Unspecified), Open
Journal article
Fluorometholone 0.1% as Ancillary Therapy for Trachomatous Trichiasis Surgery: Randomized Clinical Trial
American journal of ophthalmology, v 197, pp 145-155
01 Jan 2019
PMID: 30267699
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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randomized were 39:13:39:13:38:13 in the respective groups, and 1 subject in the 8-weeks fluorometholone group was withdrawn.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.
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Details
- Title
- Fluorometholone 0.1% as Ancillary Therapy for Trachomatous Trichiasis Surgery: Randomized Clinical Trial
- Creators
- John H KempenRedda Tekle-Haimanot - St. Paul's Hospital Millennium Medical CollegeLelisa HundumaMenilik Alemayehu - Eye Department, Shashemene Referral Hospital, Shashemene, EthiopiaMaxwell Pistilli - Drexel University, Epidemiology and BiostatisticsAida Abashawl - Eye Department, Shashemene Referral Hospital, Shashemene, EthiopiaScott D Lawrence - University of Michigan–Ann ArborWondu Alemayehu - Fred Hollows Foundation
- Publication Details
- American journal of ophthalmology, v 197, pp 145-155
- Publisher
- Elsevier
- Number of pages
- 11
- Grant note
- P30 EY001583 / NEI NIH HHS
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Epidemiology and Biostatistics
- Web of Science ID
- WOS:000454373600018
- Scopus ID
- 2-s2.0-85056255859
- Other Identifier
- 991021860800804721
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Ophthalmology