Effect of Sodium Chloride 5% Solution as an Adjuvant Treatment With Antimicrobial Therapy in the Treatment of Bacterial Infectious Keratitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Control of infection
研究概览
简要总结
This study aims to detect the effect of sodium chloride 5% solution as an adjuvant treatment with antimicrobial therapy in treatment of bacterial infectious keratits and to assess whether NaCl 5% accelerates epithelial healing, improves microbial eradication, and enhances visual outcomes in bacterial infectious keratitis.
详细描述
Prospective randomized control study to detect the effect of sodium chloride 5% solution as an adjuvant treatment with antimicrobial therapy in treatment of bacterial infectious keratits and to assess whether NaCl 5% accelerates epithelial healing, improves microbial eradication, and enhances visual outcomes in bacterial infectious keratitis.Data study will include two groups classified as follow : the first group will include treatment of microbial keratitis by antibiotic with sodium chloride 5% , the second group will include treatment by antibiotic only
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IncluInclusion Criteria
- •Age ≥ 18 years.
- •Clinically diagnosed bacterial infectious keratitis
- •Positive corneal scraping or strong clinical suspicion of bacterial cause.
- •Ability to provide informed consent and attend follow-up visits
排除标准
- •• Fungal, viral, or acanthamoeba keratitis.
- •Recent (<7 days) topical corticosteroid use.
- •Corneal perforation or impending perforation.
- •History of hypersensitivity to study agents.
- •Systemic immunocompromised state (uncontrolled diabetes, Human immune defecinicy virus).
- •Poor compliance expected with follow-up.
研究组 & 干预措施
Intervention group
treatment of microbial keratitis by antibiotic with sodium chloride 5%
干预措施: Sodium chloride 5% solution (Drug)
Intervention group
treatment of microbial keratitis by antibiotic with sodium chloride 5%
干预措施: quinolones (Drug)
Control group
Treatment of microbial keratitis by antibiotics only
干预措施: quinolones (Drug)
结局指标
主要结局
Control of infection
时间窗: 6 months
Improvement of manifestation according to rate of healing
次要结局
未报告次要终点
研究者
Nancy Safwat Kaldes
Principal Investigator
Sohag University