Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Postoperative Inflammation in Patients Having Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- day 15 evaluation of anterior chamber
研究概览
简要总结
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery
详细描述
Study of 15 +-1 day, double-masked, randomized, two arms, parallel groups to confirm the efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery
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
- Double (Participant, Investigator)
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
- •patients having cataract surgery
排除标准
- •Uncontrolled glaucoma or intraocular hypertension;
- •Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs;
- •A history of chronic or recurrent ocular inflammatory disease;
- •Uncontrolled diabetes mellitus and diabetic retinopathy ;
- •Patients with sight in a single eye;
- •Iris atrophy in the eye to be operated;
- •Pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods;
- •Known or suspected allergy or hypersensitivity to any component of study medication;
- •A history or any other evidence of severe systemic disease
研究组 & 干预措施
antibiotic steroid drops/single vial
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery
干预措施: antibiotic/steroid combination (Drug)
antibiotic steroids drops
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery
干预措施: moxifloxacin / dexamethasone (Drug)
结局指标
主要结局
day 15 evaluation of anterior chamber
时间窗: 15 days pos-op
次要结局
- day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score(15 days pos-op)