NCT01946828Unknown不适用
Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
The objective of this clinical trial is to evaluate the FIM optimal configuration and confirm the safety and performance/efficacy of the FIM when exposed to a larger and more varied population of users.
详细描述
70 Eligible subjects will be enrolled to the study and examined with the FIM to determine the degree of pupil dilation/Contraction resistance.
The study will be conducted in two main stages: 1) pupil dilation measuring and 2) functional examination. The tests' sequence will be randomized, at least 30 minutes between each test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy and not diagnosed with any chronic disease that might influence the eye and pupilary muscle.
- •Age 18-45 years old.
- •Willing and able to sign the informed consent, after reading the study information form
排除标准
- •Any known or diagnosed neurological disorders.
- •A known medical history of ophthalmic surgery or any other disease that might influence the iris control muscle.
- •Volunteers with a narrow or closed angle of the anterior chamber
- •Presence of a corneal pathology which precludes measurement of the pupil dilatation
- •Using of psychiatric medications
- •Pregnancy
- •Recent use (last 48hr) of pupil dilator eye drops.
- •The volunteer is participating in other trials using drugs or devices
- •Drug or alcohol abuse
结局指标
主要结局
Safety
时间窗: 4 months
number, severity and causality of unexpected, device related adverse events
Functionality
时间窗: 4 months
Functionality - ability to perform standard ophthalmologic examination
次要结局
- Usability(4 months)
研究者
研究点 (2)
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