Engineering Evaluation of an Eye Movement Monitor Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Device measurement of visually guided horizontal saccade amplitude
研究概览
简要总结
The objective of the engineering evaluation is to verify and validate the design of an eye movement monitor device, the Retitrack, for recording, viewing, measuring, and analyzing temporal characteristics of fixation and saccadic responses in human eyes when viewing a visual stimulus.
This engineering evaluation is not an applicable clinical trial. This is a design validation of the mechanism of action of the device to measure eye movement. This is not a clinical trial to evaluate the effect of an intervention on biomedical or other health-related outcomes.
详细描述
This non-significant risk device evaluation involves obtaining retinal images and eye movement measurements with the Retitrack device for purposes of design verification and validation testing. These measurements are not intended for use in diagnosing, preventing, monitoring, or alleviating a medical condition. This evaluation is not intended to assess biomedical or other health-related outcomes.
The evaluation involves the voluntary participation of up to 40 healthy adults who participate in a single device testing visit conducted over one or two days. The Retitrack is used to assess the alignment of the eye for image capture, the ability to measure and analyze eye movements for fixational and visually guided saccadic responses, and the usability of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •History of good health
- •Willing to participate in testing over 1 to 2 days with rest periods
- •Willing to participate in device testing involving viewing visual targets, moving eyes as directed, and holding head steady
- •Willing to have retinal images recorded for eye movement measurements
排除标准
- •Refractive correction with glasses or contact lenses of more than 12 diopters of myopia or 4 diopters of hyperopia in either eye
- •Active eye disease in either eye
- •History of ocular surgery or ocular trauma in either eye within the past three months
- •Ocular conditions in either eye that could interfere with obtaining a clear retinal image
- •Ocular conditions in either eye that could affect the ability to view a stimulus or limit eye movement
- •Neurological conditions that could affect eye movements
研究组 & 干预措施
Design validation of mechanism of action of an eye movement measurement device
Participants have retinal images captured with the Retitrack device to measure eye movements. The eye movement measurements are intended to validate the mechanism of action of the device.
干预措施: Retitrack (Device)
结局指标
主要结局
Device measurement of visually guided horizontal saccade amplitude
时间窗: 1 day (Single timepoint)
Horizontal saccade amplitude (in degrees)
Device measurement of involuntary fixational microsaccade velocity
时间窗: 1 day (Single timepoint)
Microsaccade velocity (in degrees/second)
Device measurement of involuntary fixational microsaccade amplitude
时间窗: 1 day (Single timepoint)
Microsaccade amplitude (in degrees)
Device measurement of visually guided horizontal saccade velocity
时间窗: 1 day (Single timepoint)
Horizontal saccade velocity (in degrees/second)
次要结局
未报告次要终点