NCT03025945已完成不适用
Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
Intuor Technologies, Inc.0 个研究点目标入组 662 人开始时间: 2013年10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
- 662
- 主要终点
- Post-operative Clinical Findings of Cystoid Macular Edema
研究概览
简要总结
Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Subjects, 18 and older subjects with visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.
排除标准
- •previous uveitis (<1 year) previous anterior segment intraocular surgery hypersensitivity or allergy to NSAIDs
研究组 & 干预措施
Saline Solution
Placebo Comparator
sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily
干预措施: Saline Solution (Drug)
nepafenac 0.3%
Experimental
nepafenac 0.3% ophthalmic solution dosed once daily
干预措施: Nepafenac 0.3% (Drug)
结局指标
主要结局
Post-operative Clinical Findings of Cystoid Macular Edema
时间窗: 6 weeks
post-operative macular volume (mm)
次要结局
未报告次要终点
研究者
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