NCT00348244已完成4 期
A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single
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
- •· Male or female > 18 years of age scheduled to undergo cataract surgery with surgeon expectation of 20/20 BCVA postoperatively
- •Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
- •Ability to provide informed consent and likely to complete all study visits
排除标准
- •· Known contraindication to any study medication or any of their components
- •Uncontrolled systemic disease
- •Required use of ocular medications other than the study medications during the study
- •Abnormal pre-operative OCTs if obtainable
- •Diabetic patients with a history of macular edema or diabetic retinopathy
- •AMD patients with less than a 20/20 surgical outcome expectation, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease
研究者
研究点 (1)
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