Comparison of an Anesthetic and Dilating Gel Cocktail Versus the Standard Pre-operative Pharmacologic Regimen for Cataract Surgery on Corneal Anesthesia and Pupil Dilation.
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
- 是
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
Dr. Sherif R El-Defrawy
Principal Investigator
Queen's University
