# Fluorometholone as Adjunctive Therapy for Trachomatous Trichiasis Surgery

> **NIH NIH UG1** · MASSACHUSETTS EYE AND EAR INFIRMARY · 2021 · $917,801

## Abstract

Trachoma, the leading infectious cause of blindness in the world, mainly affects the poorest of the poor in
endemic areas and females more than males. Trachomatous trichiasis (TT) is a complication of the chronic
trachoma-induced scarring, and is a key mechanism leading to blindness from trachoma. For this reason,
mass corrective eyelid surgical treatment of TT is a core global programmatic strategy. Presently, there is
great programmatic activity globally in carrying out such surgery, which provides the promise of greatly
reducing visual impairment including blindness from this ancient scourge. Unfortunately, recurrence of TT after
surgery (postoperative TT) is common, probably occurring in over 20% of cases when surgery is performed by
integrated eye care worker surgeons trained according to World Health Organization (WHO) recommendations
in the programmatic setting. Taking the 20% figure, and the published estimate that 3.2 million need TT
surgery, approximately 640,000 cases of postoperative TT will be generated. Postoperative TT is difficult to
treat; the WHO recommends referral to an ophthalmologist familiar with the problem when reoperation is
needed. However, such ophthalmologist services are seldom available in the remote, impoverished regions
affected by trachoma, leaving the large majority of patients with postoperative TT in the predicament of high
risk of blindness and pain. Practical strategies to reduce the incidence of postoperative TT hold the potential to
reduce low vision and blindness arising from trachoma. Because perioperative topical corticosteroids are
effective in limiting postoperative inflammation and scarring for a wide range of ophthalmic surgeries, our group
explored the safety and possible benefits of fluorometholone 0.1% eyedrops as ancillary perioperative therapy
in a preliminary randomized trial of three candidate doses in comparison with placebo in 154 eyes/upper
eyelids of 154 patients with trachoma. Fluorometholone 0.1% is useful for treating local ocular surface
inflammation but has poor intraocular effect, which is expected to give a safety advantage when no intraocular
effect is wanted. It also is a widely available, low-cost generic drug, which we expect would be feasible to use
in a programmatic context. Our preliminary study found an approximate one-third reduction in TT recurrence in
the three active treatment groups compared with both placebo-treated eyes and contralateral untreated eyes,
with minimal safety issues. To confirm or refute whether adjunctive fluorometholone 0.1% eyedrop treatment
would be a programmatically useful strategy worthy of widespread adoption, we propose to conduct a full-scale
randomized field trial comparing the efficacy and safety of fluorometholone 0.1% eyedrops twice daily vs.
placebo as adjunctive medical therapy for TT surgery. Cost-effectiveness analysis of clinical trial results will
guide programs as to the value of the treatment. The study (N=2254 patients) is powered...

## Key facts

- **NIH application ID:** 10206149
- **Project number:** 5UG1EY030420-03
- **Recipient organization:** MASSACHUSETTS EYE AND EAR INFIRMARY
- **Principal Investigator:** JOHN H KEMPEN
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $917,801
- **Award type:** 5
- **Project period:** 2019-09-30 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10206149

## Citation

> US National Institutes of Health, RePORTER application 10206149, Fluorometholone as Adjunctive Therapy for Trachomatous Trichiasis Surgery (5UG1EY030420-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10206149. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*