NCT00330824已完成不适用
Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Post Operative Inflammation in Patients Having LASIK Surgery
Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- day 15 evaluation of anterior chamber
研究概览
简要总结
Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK
详细描述
antibiotic/steroid combination compared to individuals components 15 days of treatment
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients having LASIK surgery;
- •men or women of any race, between 18 and 50 years old, presenting up to 8 degrees of myopia or up to 4 degrees of hypermetropia, or up to 3 degrees of astigmatism, without any other associated ocular problems
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 (single vial)
Experimental
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery
干预措施: antibiotic/steroid combination (Drug)
antibiotic / steroid (2 vials)
Active Comparator
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK 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)
研究者
研究点 (1)
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