NCT00690222终止不适用
A Comparison of Intracameral Phenylephrine 2% and Tropicamide 0.2% With Topical Phenylephrine 2.5% and Tropicamide 1% for Pupillary Dilation During Cataract Surgery on Patients With and Without Pseudoexfoliation Syndrome.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Pupil size
研究概览
简要总结
The purpose is to determine if an intracameral solution of 0.2% tropicamide and 2% phenylephrine can dilate the pupil for cataract surgery as well as pre-operative topical 1% tropicamide and 5% phenylephrine. We will be looking at two separate groups of patients, those with and those without pseudoexfoliation syndrome.
We will be looking at how each method affects the size of the pupil at the beginning and at the end of cataract surgery. In addittion, we will look at what effect the two different methods have on blood pressure and heart rate in the pre-operative, peri-operative and post-operative periods.
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
- None
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
- •Ability to give consent
- •Greater than 18 years of age
- •Planned clear cornea cataract extraction and placement of foldable posterior chamber intraocular lens
- •No secondary procedure planned (i.e. trabeculectomy, keratectomy, corneal transplant, vitreo-retinal procedure etc.)
- •Systemic condition capable of undergoing topical anesthesia
- •No previous intraocular surgery
- •Pseudoexfoliation syndrome (PXF) for group 1
- •No Pseudoexfoliation syndrome for group 2
排除标准
- •Not fulfilling inclusion criteria
- •Any iris pathology including but not limited to posterior synechia, iridocorneal endothelial syndrome, corectopia, traumatic mydriasis, Horner's syndrome, Adie's pupil, cyclodialysis, iridodialysis
- •Previous or concurrent use of Flomax® or similar alpha-antagonist medication
- •Corneal pathology affecting pupil magnification or measurement (keratoconus, peripheral thinning, sclerocornea, scarring)
- •Uncontrolled Hypertension (greater than 170/90 on pre-operative assessment on day of surgery as measured by automated DATEX monitor)
结局指标
主要结局
Pupil size
时间窗: At beginning and completion of cataract surgery
次要结局
- Heart rate(Peri-operatively)
- Blood pressure(Peri-operatively)
研究者
研究点 (2)
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