Fluorometholone Study

Trial of Topical Fluorometholone as Adjunctive Therapy for Bacterial Corneal Ulcers

The investigators seek to determine whether adjunctive topical fluorometholone (FML) improves best-corrected visual acuity (BCVA) at 3 months in patients with bacterial corneal ulcers compared with standard topical antibiotic therapy alone.

In this prospective, randomized, parallel-group clinical cohort study, the investigators seek to determine whether adjunctive topical fluorometholone (FML) improves best-corrected visual acuity (BCVA) at 3 months in patients with bacterial corneal ulcers compared with standard topical antibiotic therapy alone. The primary objective is to compare the mean 3-month BCVA (logMAR) between the intervention arm (standard topical antibiotic therapy + FML 0.1%) and a control arm (standard topical antibiotic therapy alone).

Inclusion Criteria:

1. Adults aged ≥ 18 years.

2. Clinical diagnosis of a bacterial corneal ulcer based on slit-lamp examination.

3. Ulcer severity classified as:

   • Mild: Diameter ≤ 3 mm AND stromal depth ≤ 1/3 thickness.
   • Moderate: Diameter >3-6 mm and/or stromal depth > 1/3-2/3.
   • Severe: Diameter >6 mm and/or stromal depth >2/3.

4. Completed microbiologic work-up including ≥ 1 of:

   • Corneal culture, or
   • PCR testing.

5. Received ≥ 48-96 hours of empiric topical antibiotic therapy prior to randomization (fluoroquinolone monotherapy or fortified cefazolin/tobramycin based on standard of care).

6. Able and willing to provide informed consent and comply with study visits.

Exclusion Criteria:

1. Clinical or laboratory evidence of:

   • Herpes simplex keratitis.
   • Acanthamoeba keratitis.
   • Fungal keratitis (positive smear, culture or PCR).

2. Corneal perforation or imminent perforation at presentation.

3. Current use of:

   • Topical corticosteroids in the study eye, or
   • Systemic corticosteroids during this ulcer episode.

4. History of steroid-responsive glaucoma or uncontrolled intraocular pressure (IOP).