Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- endothelial cell count
研究概览
简要总结
The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.
详细描述
Although cataract surgery is generally considered a safe procedure resulting in a favourable visual outcome, surgical complications do occur. The most feared complication is postoperative endophthalmitis which is an infectious condition caused by micro-organisms introduced to the interior of the eye during or after the surgical procedure.
As endophthalmitis is an infection, it should be preventable by antibiotic treatment.
Prophylactic antibiotic treatment can be given as topical treatment preoperatively, or during surgery directly into the anterior chamber, or as a subconjunctival, or it can be given as topical treatment postoperatively.
The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of visually significant cataract
排除标准
- •Has known allergies to moxifloxacin
- •Has significant ocular co-morbidities in one or both eyes which may include (but is not limited to): advanced glaucoma, advanced or active macular degeneration, Fuchs corneal dystrophy, prior corneal transplantation, advanced diabetic eye disease, history of retinal detachment or any patient that would require billing a complex cataract procedure for any reason
- •Has a known history of a condition which causes an immuno-compromised host state
研究组 & 干预措施
moxifloxacin intracameral
moxifloxacin injection given at conclusion of cataract intervention
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
endothelial cell count
时间窗: 6-month; 1 year; 2 years
次要结局
- endophthalmitis incidence(1 month)
研究者
Rodrigo Pessoa Cavalcanti Lira
Professor
Universidade Federal de Pernambuco