Corneal Ulcer (Diagnosis), Keratitis Bacterial
Conditions
Brief 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.
Detailed 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).
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
Sponsors
Vishal Jhanji
University of Pittsburgh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, randomized, parallel-group clinical cohort study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) | From enrollment to 3 months | BCVA (logMAR) at 3 months post-randomization in the study eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
Countries
United States
Contacts
CONTACTRose Carla Aubourg, BA
CONTACTSarah Waters
PRINCIPAL_INVESTIGATORVishal Jhanji, MD
University of Pittsburgh
Outcome results
None listed