Study of Stimulus Parameters in Flicker Electroretinogram (ERG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Flicker harmonic amplitude
研究概览
简要总结
The electroretinogram (ERG) is a diagnostic test that measures the electrical activity generated by cells in the retina in response to a light stimulus. Typically, an ERG is recorded with white flash when the pupil is dilated. RETeval Visual Diagnostic Device (RETeval) generates an array of color flashes, which allows studying whether color flash would be a useful diagnostic tool.
Full pupil dilation is required to obtain a response from the whole retina. However, this requirement often limits a patient's flow in the clinic and increases the overall time patients spend at the eye practitioner. RETeval provides the possibility of recording ERGs in un-dilated pupils therefore making the whole exam easier and shorter. These results need to be compared to the classic, fully dilated ERG and evaluated for efficiency.
The purpose of this research study is to use the RETeval device to measure the eye's electrical response and how it changes with different stimuli such as changing flash color or pupil dilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adult volunteers
- •volunteers able to get their pupil fully dilated
排除标准
- •pregnant women
- •subjects with
- •light sensitivity
- •photosensitive epilepsy
- •allergies or sensitivity to pupil dilation ophthalmic solutions
- •history of glaucoma
- •cardiac dysrhythmia will not be invited to participate in this study.
- •Pregnancy status, light sensitivity and photosensitive epilepsy will be based on volunteer's providing this information at the time of signing the consent form
结局指标
主要结局
Flicker harmonic amplitude
时间窗: up to 2 mnths
Flicker harmonic implicit time
时间窗: up to 2 months
Flicker fundamental amplitude
时间窗: up to 2 months
Flicker fundamental implicit time
时间窗: up to 2 months
次要结局
未报告次要终点
