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临床试验/NCT00348244
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

Innovative Medical1 个研究点 分布在 1 个国家开始时间: 2006年7月4日最近更新:
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

申办方类型
Industry

研究点 (1)

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