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| Name | Class |
|---|---|
| University of Pittsburgh Medical Center | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Standard Topical Antibiotic Therapy + Fluorometholone |
|
| Control Arm | Active Comparator | Standard Topical Antibiotic Therapy Alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjunctive Topical Fluorometholone (FML) 0.1% | Drug | Adjunctive Topical Fluorometholone (FML) 0.1% will be used |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) | BCVA (logMAR) at 3 months post-randomization in the study eye. | From enrollment to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Improvement | Change in BCVA from baseline to weeks 1 and 4, and 3 months. | From enrollment (Day 1) to Week 1, Month 1, Month 3. |
| Time to re-epithelialization | Time to re-epithelialization |
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Inclusion Criteria:
Adults aged ≥ 18 years.
Clinical diagnosis of a bacterial corneal ulcer based on slit-lamp examination.
Ulcer severity classified as:
Completed microbiologic work-up including ≥ 1 of:
Received ≥ 48-96 hours of empiric topical antibiotic therapy prior to randomization (fluoroquinolone monotherapy or fortified cefazolin/tobramycin based on standard of care).
Able and willing to provide informed consent and comply with study visits.
Exclusion Criteria:
Clinical or laboratory evidence of:
Corneal perforation or imminent perforation at presentation.
Current use of:
History of steroid-responsive glaucoma or uncontrolled intraocular pressure (IOP).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rose Carla Aubourg, BA | Contact | 412-642-7888 | aubourgrc@upmc.edu | |
| Sarah Waters | Contact | 412-642-7888 | waterssa2@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vishal Jhanji, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Vision Institute | Pittsburgh | Pennsylvania | 15219 | United States |
The data would be made available upon reasonable request.
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| ID | Term |
|---|---|
| D003320 | Corneal Ulcer |
| D004194 | Disease |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
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| ID | Term |
|---|---|
| D005469 | Fluorometholone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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A prospective, randomized, parallel-group clinical cohort study.
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| Standard Topical Antibiotic Therapy | Drug | Patients will be treated with antibiotics (Cefazolin, Tobramycin or Moxifloxacin) we per treating physician |
|
| From enrollment to 3 months |
| Intraocular Pressure (IOP) | IOP measurements at all follow-up visits. | From enrollment (Day 1) to Day 3, 1 Week, 1 Month, 3 Months. |
| Complications | Progressive thinning or perforation; hypopyon development or increase; endophthalmitis; fibrin formation; or worsening infiltrate size or depth ≥50%. | From enrollment to Month 3. |
| D005128 |
| Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |