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临床试验/NCT05079854
NCT05079854Unknown4 期

Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月1日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • open globe trauma

排除标准

  • endophthalmitis at the beginning

研究组 & 干预措施

INTRACAMERAL MOXIFLOXACIN

Active Comparator

After the surgery, the antibiotic is intracameral administered, Moxifloxacin 0.5% 0.1mL.

干预措施: Intraocular Instillation Solution (Drug)

TOPICAL MOXIFLOXACIN

Active Comparator

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

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mauricio Maia

Clinical Professor

Federal University of São Paulo

研究点 (1)

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