FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial
The FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial is a randomized, double-masked, placebo controlled clinical trial that is funded by the National Eye Institute. The study is designed to assess the efficacy and safety of fluorometholone vs. placebo eyedrops as ancillary therapy for patients in Ethiopia with trachomatous trichiasis (TT) who are undergoing lid rotation/correction surgery. The study goals are to determine whether fluorometholone drops used twice daily following TT surgery improves the outcome of the surgery, and whether it is safe and cost-effective.
What is Trachomatous trichiasis (TT), and why is the FLAME study important?
Trachoma is a bacterial infection and is the leading infectious cause of blindness worldwide. People with Trachomatous trichiasis (TT) have eyelashes turned inward and touching the eye. In addition to leading to blindness, this also causes severe chronic eye pain. Ethiopia is the home of more patients with both trachoma and trachomatous trichiasis than any other nation in the world. In the last few years, the Fred Hollows Foundation (FHF), in partnership with the Ethiopia Federal Ministry of Health, has been carrying out large scale TT surgery programs. The treatment involves surgically turning the eyelashes outward from the eye.
Unfortunately, an undesirably high recurrence rate following trichiasis surgery limits the benefits of the surgery, and also reduces community confidence in the surgery resulting in less utilization by people who could benefit from it. Post-operative TT is a difficult problem, with worse outcomes of surgical repair than primary TT. Because of the dire situation of patients who have postoperative TT with high risk of blindness, ongoing pain, and limited management options, prevention of postoperative TT is of paramount importance.
Our study will test whether using topical fluorometholone drops following trichiasis surgery will reduce the risk of recurrent trichiasis.
A total of approximately 2254 subjects will be enrolled in FLAME. Patients will be screened for eligibility for the FLAME Trial by Field Teams. Subjects must be 15 years of age or older, have upper lid TT in at least one eye, and be planning to undergo TT surgery, in addition to other criteria. Eligible participants who are willing to participate in the study will be asked to give consent.
Trained TT surgeons will conduct the TT surgery at a heath facility or other site within the community. Following surgery, Field Team members will dispense the study eye drops and instruct the patients on how to use them (twice daily for exactly 28 days). The Investigational Pharmacy at UPenn repackaged the fluorometholone and placebo drops into identical bottles, so neither the patients nor the study team in Ethiopia will not know which medication the patient is receiving.
Each subject will participate in five study visits: Visit 1 (to collect baseline data, ensure eligibility and complete enrollment); Visit 2 (to conduct surgery and collect information on surgical details; and three follow-up visits (28 days, 6 months and 1 year) to obtain outcome and adherence data. The Primary outcome of the study is the incidence of postoperative recurrence of TT by one year
CPOB’s Role in FLAME
CPOB serves as the Data Center (DC) for the study. The Data Center provides leadership and expertise on study design, implementation and maintenance of a high quality data management system, data monitoring, statistical analysis for interim trial monitoring and publication of trial findings. Because the study is being conducted in Ethiopia, which requires employment of the study team by a registered entity, coordination work will be done by the Field Coordinating Center in Ethiopia.
For more information about the FLAME Study, visit clinicaltrials.gov