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临床试验/NCT00956462
NCT00956462Unknown不适用

Topical Steroids Versus Topical Non-steroidal Anti-inflammatory Drugs Following Ahmed Valve Glaucoma Drainage Device Surgery

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2007年7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
入组人数
36
试验地点
1
主要终点
Intraocular pressure

研究概览

简要总结

This study aims to evaluate the eye pressure response to non-steroidal anti-inflammatory eye drops as compared to steroid eye drops following glaucoma surgery.

详细描述

Glaucoma is a chronic disease of the eye which results in gradual loss of nerve fibres, resulting in visual loss. The mainstay of treatment is reduction of intraocular pressure (IOP), which has been shown to preserve vision, and glaucoma surgery aims to achieve this. One type of surgery involves insertion of a glaucoma drainage device (GDD). Following surgery steroid eye drops are commonly used in order to reduce the inflammation that occurs as a result of the surgery. However, a common side effect of steroid eye drops is a rise in eye pressure. Non-steroidal anti-inflammatory drugs (NSAID) eye drops do not have this side effect and are used as an alternative to steroids following other types of eye surgery. Use of NSAID drops following GDD surgery may result in improved eye pressure. This study aims to evaluate the eye pressure response to NSAID eye drops following GDD 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 - 85 years of age
  • Undergoing glaucoma drainage device surgery
  • Exclusion criteria
  • Unable to consent
  • Undergoing combined GDD and cataract surgery
  • Patients with conditions requiring additional anti-inflammatory medications e.g., uveitic glaucoma, previous corneal transplant
  • Patients with prior history of corneal ulceration
  • Breast-feeding (nursing) mothers
  • Pregnant or planning to become pregnant during the trial period
  • Allergic to Ketorolac Tromethamine, or had an allergic-type reaction to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs used for pain relief or arthritis

排除标准

  • 未提供

研究组 & 干预措施

NSAID

Experimental

干预措施: Ketorolac (NSAID) versus Dexamethasone (steroid) (Drug)

Steroids

Active Comparator

干预措施: Ketorolac (NSAID) versus Dexamethasone (steroid) (Drug)

结局指标

主要结局

Intraocular pressure

时间窗: Six weeks

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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