Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to complete clinical resolution(days)
研究概览
简要总结
Bacterial keratitis is a potentially sight-threatening corneal infection that is commonly treated with intensive topical antibiotics. Despite appropriate therapy, some cases show inadequate clinical response, particularly when the infection involves the deep corneal stroma. Limited penetration of topical antibiotics into deeper corneal layers may contribute to treatment failure in these recalcitrant cases.
Intrastromal antibiotic injection is a targeted drug-delivery approach that allows high local antimicrobial concentrations directly at the site of infection. Moxifloxacin is a broad-spectrum fluoroquinolone with proven efficacy in bacterial keratitis and favorable corneal tissue penetration. However, evidence regarding the clinical benefit and safety of intrastromal moxifloxacin as an adjunctive treatment remains limited.
This randomized controlled trial aims to evaluate the efficacy and safety of intrastromal moxifloxacin injection as an adjunct to standard topical moxifloxacin therapy compared with topical therapy alone in patients with recalcitrant bacterial keratitis. The primary outcome is time to complete clinical resolution of infection. Secondary outcomes include visual acuity improvement, ulcer healing rate, need for additional interventions, and treatment-related complications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be performed using a computer-generated random sequence. Allocation will be concealed using sealed opaque envelopes.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age ≥ 18 years
- •Clinical diagnosis of bacterial keratitis confirmed by corneal scraping and microbiology
- •Recalcitrant keratitis defined as no significant clinical improvement after 48-72 hours of intensive topical antibiotic therapy
- •Ability to provide written informed consent
排除标准
- •Fungal, viral, or acanthamoeba keratitis
- •Corneal perforation or impending perforation
- •Known hypersensitivity to fluoroquinolones
- •Pregnancy or lactation
- •Immunocompromised state or current systemic immunosuppressive therapy
- •Previous intrastromal or intracameral antibiotic injection for the same episode
研究组 & 干预措施
Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy
Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.
干预措施: Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy (Drug)
Standard topical moxifloxacin therapy alone
• Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response
干预措施: Standard topical moxifloxacin therapy alone (Drug)
结局指标
主要结局
Time to complete clinical resolution(days)
时间窗: weekly till complete healing
Time to complete clinical resolution, defined as corneal re-epithelialization with disappearance of stromal infiltrate and anterior chamber reaction.
次要结局
- • Epithelial defect size(mm)(weekly for one month)
- Hypopyon height(mm).(weekly for one month)
- Pain score on visual Analog scale (VAS, 1 - 10).(weekly for one month)
- Best-corrected visual acuity (BCVA) (LogMAR or Snellen)(weekly for one month)
- Complications (perforation, thinning, endophthalmitis).(after 3 months)
研究者
Mahmoud Ramadan
lecturer of ophthalmology
Minia University