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

Eye Diseases Clinical Trial

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

Clinical Trial Summary

This study aims : - To assess the efficacy of fluorometholone 0.1% one drop twice daily for four weeks in reducing the incidence of post-operative trachomatous trichiasis (TT) when given as adjunctive therapy with TT surgery in the programmatic setting - To assess whether such treatment is sufficiently safe for wide-scale implementation in TT programs. - To estimate the costs of adding fluorometholone 0.1% treatment to TT surgery per case of postoperative TT averted, and to characterize the value of such treatment under a range of plausible health economic circumstances

Clinical Trial Description

The investigators are pursuing an agenda to evaluate a new potentially cost-effective approach to improving trichiasis surgery outcomes: perioperative topical anti-inflammatory therapy. Inflammation-whether induced by the trachoma disease process or surgery itself-most likely contributes to progressive cicatrization leading to failure of lid rotation surgery in a clinically important proportion of TT cases. The investigators hypothesize that adjunctive topical fluorometholone therapy following trichiasis surgery will reduce the risk of recurrent trichiasis and will be acceptably safe. The rationale for the efficacy aspect of this hypothesis is that interruption of inflammation postoperatively would reduce postoperative scarring/contracture driven by ongoing disease-driven inflammation and/or surgically-induced inflammation thus reducing the incidence of TT recurrence (post-operative TT) and other inflammation-related outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04149210
Study type Interventional
Source Massachusetts Eye and Ear Infirmary
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 14, 2021
Completion date December 30, 2025
View Details
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