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临床试验/NCT02466607
NCT02466607已完成不适用

Study of Stimulus Parameters in Flicker Electroretinogram (ERG)

LKC Technologies, Inc.2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2015年3月1日最近更新:
适应症

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

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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