Trial of Topical Fluorometholone as Adjunctive Therapy for Bacterial Corneal Ulcers
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 18 years.
- •Clinical diagnosis of a bacterial corneal ulcer based on slit-lamp examination.
- •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/
- •Severe: Diameter >6 mm and/or stromal depth >2/
- •Completed microbiologic work-up including ≥ 1 of:
- •Corneal culture, or
- •PCR testing.
- •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.
排除标准
- •Clinical or laboratory evidence of:
- •Herpes simplex keratitis.
- •Acanthamoeba keratitis.
- •Fungal keratitis (positive smear, culture or PCR).
- •Corneal perforation or imminent perforation at presentation.
- •Current use of:
- •Topical corticosteroids in the study eye, or
- •Systemic corticosteroids during this ulcer episode.
- •History of steroid-responsive glaucoma or uncontrolled intraocular pressure (IOP).
研究组 & 干预措施
Intervention Arm
Standard Topical Antibiotic Therapy + Fluorometholone
干预措施: Adjunctive Topical Fluorometholone (FML) 0.1% (Drug)
Intervention Arm
Standard Topical Antibiotic Therapy + Fluorometholone
干预措施: Standard Topical Antibiotic Therapy (Drug)
Control Arm
Standard Topical Antibiotic Therapy Alone
干预措施: Standard Topical Antibiotic Therapy (Drug)
结局指标
主要结局
Best Corrected Visual Acuity (BCVA)
时间窗: From enrollment to 3 months
BCVA (logMAR) at 3 months post-randomization in the study eye.
次要结局
- Visual Improvement(From enrollment (Day 1) to Week 1, Month 1, Month 3.)
- Time to re-epithelialization(From enrollment to 3 months)
- Intraocular Pressure (IOP)(From enrollment (Day 1) to Day 3, 1 Week, 1 Month, 3 Months.)
- Complications(From enrollment to Month 3.)
研究者
Vishal Jhanji
Professor of Ophthalmology
University of Pittsburgh