Fluorometholone Study

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).

• Adjunctive Topical Fluorometholone (FML) 0.1% (Drug): Adjunctive Topical Fluorometholone (FML) 0.1% will be used
• Standard Topical Antibiotic Therapy (Drug): Patients will be treated with antibiotics (Cefazolin, Tobramycin or Moxifloxacin) we per treating physician

Primary outcomes

• Best Corrected Visual Acuity (BCVA) [From enrollment to 3 months]: BCVA (logMAR) at 3 months post-randomization in the study eye.

Secondary outcomes

• Visual Improvement [From enrollment (Day 1) to Week 1, Month 1, Month 3.]: Change in BCVA from baseline to weeks 1 and 4, and 3 months.
• Time to re-epithelialization [From enrollment to 3 months]: Time to re-epithelialization
• Intraocular Pressure (IOP) [From enrollment (Day 1) to Day 3, 1 Week, 1 Month, 3 Months.]: IOP measurements at all follow-up visits.
• Complications [From enrollment to Month 3.]: Progressive thinning or perforation; hypopyon development or increase; endophthalmitis; fibrin formation; or worsening infiltrate size or depth ≥50%.

Sex: All, ages: 18 Years to any

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).

• Vishal Jhanji, MD, Principal investigator, University of Pittsburgh