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临床试验/NCT02629471
NCT02629471暂停不适用

Study of the Effects of Light Flashes on the Visual System

LightGuard1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
发起方
LightGuard
入组人数
60
试验地点
1
主要终点
visual cognition

研究概览

简要总结

Background The goal of this study is to examine the human visual and cognitive performance under the effect of bright light pulses. Exposure to visual stimulation of such pulsation may interfere with cognitive function and at certain situations this may be noticeable and may interfere with our judgment and abilities. In some of them visual or cognitive impairment from exposure to bright light flashes may result in catastrophic outcome due to the high-risk situation e.g. road accidents. Ocular exposure to a bright light can result in profound momentary transitional loss of vision. The light sources employed for visual stimulation in this study will be restricted to the range consistent with "reversible effects" (e.g. glare and flash insensitivity or "flash blindness").

The impact of an exposure to bright light depends not only on the exposure level and frequency, but also on the exposed individual's activity, psychological state, adaptation level and visual task. Glare is primarily caused by the scattering of light within the eye due to the imperfect transparency of the optical components of the eye and to a lesser extent by diffuse light passing through the scleral wall or the iris. The scattered light overlays the retinal image, thus reducing visual contrast. Excessive glare may impair visual function and lead to temporary disability.

The above mentioned effects of exposure to light and pulsating light stimulus on the visual system and cognition were studied in detail by a number of groups. These studies indicate that the visual and cognition effects of pulsating light are a function of the following parameters: pulse duration, light intensity and pulse frequency.

详细描述

Study Purpose and Rationale The purpose of this study is to evaluate the cognitive effects of exposure to flashing light stimuli by measuring the response time and level of performance of healthy human subjects during exposure to light pulsations.

Study Design and methods:

  1. Overall study design An open prospective study comprising of cognitive tests performed during and following exposure to bright flashing light stimuli.

Pre and post -cognitive test (within 1 month after the test) ophthalmological tests will be conducted. 2. Study Participants A total of 60 subjects will be recruited for this study over a span of 3 months.

The subjects will volunteer to participate in the study. Flash Tests The subject will be positioned at a selected distance from a flashing unit and a screen on which different scenarios will be projected.

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

  • •Systemically and visually Healthy (per history)
  • •Signed Informed Consent

排除标准

  • •Pregnant women
  • •Unwilling to sign informed consent
  • •Current and past history of migraine
  • •Current and post history of epilepsy or seizures
  • •Any known ocular disease in one or two eyes

研究组 & 干预措施

response time due to light flashs pulses

Experimental

light flashing effects on response time to random target appearance

干预措施: response time due to light flash pulses (Behavioral)

结局指标

主要结局

visual cognition

时间窗: instantaneous

response time to targets after flashes

次要结局

未报告次要终点

研究者

发起方
LightGuard
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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