Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- horizontal pupil diameter
研究概览
简要总结
The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.
详细描述
To the best of the authors' knowledge, there have been no clinical trials using an appropriate regimen for pupillary dilation up until now. Therefore, the authors were interested to find out the most appropriate regimen for complete ocular examination, based on the finding that a pupil diameter of 6 mm or greater is adequate for indirect ophthalmoscopy. The authors hypothesize that a single dose of 1% tropicamide and 10% phenylephrine is adequate to complete the job and are conducting this prospective randomized clinical controlled trial to prove the hypothesis.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 20 and 80 years old
- •dark iris
- •require binocular indirect ophthalmoscopy for complete ocular examination
- •signed written consent forms
排除标准
- •history of ocular trauma
- •history of intraocular surgery
- •history of laser treatment
- •previous eye drop instillation that may affect pupillary dilation
- •ocular diseases that may affect pupil size such as Horner's syndrome, Adies' pupil, glaucoma and uveitis
- •history of diabetes mellitus, severe hypertension and cardiovascular diseases
研究组 & 干预措施
A
single dose vs three doses of 1%tropicamide and 10%phenylephrine
干预措施: 1% tropicamide and 10% phenylephrine (Drug)
结局指标
主要结局
horizontal pupil diameter
时间窗: 30 min
次要结局
- systolic blood pressure(30 min)
- diastolic blood pressure(30 min)
- heart rate(30 min)
- adverse drug reaction(30 min)
研究者
Yosanan Yospaiboon
Professor
Khon Kaen University