Fluorometholone as Ancillary Therapy for TT Surgery
Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
Summary
The investigators aim to evaluate a new potentially cost-effective approach to improving
trichiasis surgery outcomes, perioperative topical anti-inflammatory therapy. The
investigators hypothesize that adjunctive topical fluorometholone therapy following
trichiasis surgery will reduce the risk of recurrent trichiasis. The rationale for this
hypothesis is that interruption of inflammation postoperatively would reduce postoperative
scarring, leading to better outcomes. As an initial step toward evaluating this modality, the
investigators believe it to be necessary to evaluate topical corticosteroid therapy in a
safety-oriented study, for which the investigators also hypothesize that fluorometholone will
have a perioperative safety profile acceptable for large-scale programmatic use. Topical
corticosteroid therapy is associated with potential risks of cataract induction and
intraocular pressure (IOP) elevation in susceptible individuals. Fluorometholone has lower
intraocular penetration than alternative corticosteroids, with correspondingly less
IOP-raising effect while still having favorable effects on conjunctival inflammation, and is
a low-cost generic drug. Its poor delivery of corticosteroid into the eye itself provides an
advantage in this setting, as the major side effects of therapy are the result of intraocular
effects, and therapy only is needed to the conjunctiva. However, prior to use in a
large-scale trial it is sensible to make sure adverse outcomes are not observed in a
substantial number of TT patients in a smaller scale trial. Secondary goals of such a trial
are to evaluate alternative topical corticosteroid dosing schedules to identify an optimal
dosing schedule and to identify any preliminary signals of potential efficacy.
Phase:
N/A
Details
Lead Sponsor:
University of Pennsylvania
Collaborators:
Berhan Public Health and Eye Care Consultancy PLC Grarbet Tehadiso Mahber Lions Club International Foundation Lions Clubs International Foundation (funding)