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临床试验/NCT00335400
NCT00335400已完成不适用

Comparison of an Anesthetic and Dilating Gel Cocktail Versus the Standard Pre-operative Pharmacologic Regimen for Cataract Surgery on Corneal Anesthesia and Pupil Dilation.

Queen's University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年3月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Pupil dilation

研究概览

简要总结

To prepare the eye for cataract surgery, drugs must be given to the eye to allow for surgery to take place. Traditionally, dilating drops and drops containing NSAIDs (to control inflammation) are given to the patient well in advance of surgery at repeated time intervals. As well, a gel containing lidocaine is applied to the eye just prior to surgery to anesthetize (reduce pain and feeling) in the area of the eye. Although effective, the procedure is time-consuming and costly for nursing staff. Recently, a few hospitals have reported success in mixing the pupil-dilating and NSAID drops with the lidocaine gel, creating an "anesthetic dilating gel". Although success has been reported, there have been no studies to clearly demonstrate that the "anesthetic dilating gel" is as effective at dilating the pupil and reducing sensitivity of the cornea during surgery than the traditional methods of drops and gel. It is possible that the dilating gel is less effective due to slower diffusion of drugs into the eye. The study will compare the effectiveness of the anesthetic dilating gel with the standard pre-operative pharmacologic regimen for cataract surgery. Stability (maintaining effectiveness over time) and contamination of the study gel will also be assessed. If the dilating gel is shown to be as effective in regards to pupil dilation and corneal anesthesia, while maintaining stability and sterility over time, hospitals can be encouraged to use such a anesthetic dilating gel routinely during pre-operative procedures before cataract surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • scheduled for first cataract surgery (i.e., first eye)

排除标准

  • previous ocular surgery,
  • pseudoexfoliation syndrome,
  • diabetes,
  • herpetic eye disease,
  • posterior synechiae,
  • previous uveitis

结局指标

主要结局

Pupil dilation

Corneal anesthesia

次要结局

  • Gel sterility
  • Gel stability
  • Patient comfort

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sherif R El-Defrawy

Principal Investigator

Queen's University

研究点 (2)

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