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临床试验/NCT00405431
NCT00405431已完成不适用

Influence of Post-Operative Cyclosporine 0.05% (Restasis) on the Success of Glaucoma Filtering Surgery

Wills Eye1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2004年3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
43
试验地点
1
主要终点
intraocular pressure

研究概览

简要总结

The purpose of this study is to determine whether reducing inflammation of the surface of the eye with topical Restasis after glaucoma surgery will improve surgical outcomes and increase patient comfort.

详细描述

Continued use of glaucoma drops can alter the outer surface of the eye and result in swelling and irritation, changing the structure of the eye. This structural change has been found to be a significant risk factor for the failure of glaucoma surgery. A comparison of how well patients do after glaucoma surgery depending on whether they use Restasis (the only prescription medication approved by the FDA for treating dry eye) or artificial tears (which can be purchased without a prescription) for 6 months following their surgery.

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

入选标准

  • Patients with uncontrolled glaucoma scheduled for filtering surgery

排除标准

  • Under 18 years of age
  • Unable to understand informed consent

研究组 & 干预措施

1

Active Comparator

Patients received restasis eyedrops during 6 month post-operative period

干预措施: Restasis (Drug)

2

Placebo Comparator

Patients receive artificial tears (Endura) during 6 month post-operative period

干预措施: Endura (artificial tears) (Drug)

结局指标

主要结局

intraocular pressure

时间窗: 6 months

次要结局

  • ocular inflammation(6 months)

研究者

发起方
Wills Eye
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marlene Moster, MD

Attending Surgeon

Wills Eye

研究点 (1)

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