Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Endophthalmitis
研究概览
简要总结
Endophthalmitis is a severe inflammatory eye condition with profound impairment of vision, which can lead to irreversible visual loss and requires immediate treatment.
There is no way to completely prevent endophthalmitis, however, through prophylactic methods, it is possible to reduce its incidence. Currently, the only technique that has reached category II of evidence in reducing the risks of endophthalmitis is the use of 5% povidone-iodine eye drops, moments before surgery. In 2007, the European Society of Cataract and Refractive Surgery (ESCRS) released a large multicenter randomized clinical trial, with data on the reduction in the rates of endophthalmitis, using the intracameral antibiotic therapy technique of perioperative cefuroxime. However, much is discussed about the risks related to the technique, such as dilutional errors, contamination, anaphylaxis and cost-effectiveness, which still makes the conduct debatable.
The study evaluates the use of intracameral Moxifloxacin 0.5% (Vigamox®) as prophylaxis in cases of endophthalmitis after open ocular trauma;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •open globe trauma
排除标准
- •endophthalmitis at the beginning
研究组 & 干预措施
INTRACAMERAL MOXIFLOXACIN
After the surgery, the antibiotic is intracameral administered, Moxifloxacin 0.5% 0.1mL.
干预措施: Intraocular Instillation Solution (Drug)
TOPICAL MOXIFLOXACIN
After the surgery, the antibiotic is topical administered, Moxifloxacin 0.5% 0.1mL.
干预措施: Moxifloxacin Ophthalmic (Drug)
结局指标
主要结局
Endophthalmitis
时间窗: 90 days
Evaluate the incidence of Endophthalmitis
次要结局
未报告次要终点
研究者
Mauricio Maia
Clinical Professor
Federal University of São Paulo
