Clinical Trials Logo
  1. Home
  2. Eyelid Diseases
  3. NCT04149210

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
See also
  Status Clinical Trial Phase
Recruiting NCT05414994 - Assessment of the Ocular Microbiome in Health and Disease
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Completed NCT02811692 - Study for Collection of Aflibercept Data in Routine Practice
Recruiting NCT06045299 - Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia Phase 3
Recruiting NCT01521065 - An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Phase 2
Completed NCT04799704 - Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic Patients.
Recruiting NCT05876689 - Swept Source OCT Imaging With the DREAM VG-OCT
Active, not recruiting NCT04123626 - A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis Pigmentosa Due to the P23H Mutation in the RHO Gene Phase 1/Phase 2
Recruiting NCT04150432 - Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children N/A
Not yet recruiting NCT05550740 - Repeated Low-Level Red-Light Therapy for Shortening Axial Length N/A
Completed NCT02332343 - Sparing of the Fovea in Geographic Atrophy Progression N/A
Completed NCT01727973 - Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy Phase 1/Phase 2
Terminated NCT01225146 - Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2) Phase 1
Completed NCT00333203 - Next Generation Ophthalmic Irrigating Solution Posterior Segment Study Phase 3
Not yet recruiting NCT05565547 - Multimodal Equipment for Teleophthalmology Assessment (META)
Recruiting NCT05158699 - Effectiveness of Periocular Drug Injection in CATaract Surgery Phase 3
Recruiting NCT06112340 - A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) Phase 2/Phase 3
Recruiting NCT06451172 - Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis Early Phase 1
Completed NCT05211089 - Manual Versus Automated Choroidal Thickness Measurements Using Swept-source Anterior Segment OCT
Not yet recruiting NCT06070467 - Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases