Trial of Topical Fluorometholone as Adjunctive Therapy for Bacterial Corneal Ulcers
Vishal Jhanji
Summary
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.
Description
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 bas…
Interventions
- DrugAdjunctive Topical Fluorometholone (FML) 0.1%
Adjunctive Topical Fluorometholone (FML) 0.1% will be used
- DrugStandard Topical Antibiotic Therapy
Patients will be treated with antibiotics (Cefazolin, Tobramycin or Moxifloxacin) we per treating physician
Location
- UPMC Vision InstitutePittsburgh, Pennsylvania