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临床试验/NCT05476523
NCT05476523招募中不适用

Development and Validation of a Novel Eye-Tracking Software-based Platform to Extract Oculometric Measures

NeuraLight1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2022年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
NeuraLight
入组人数
2,000
试验地点
1
主要终点
Efficacy of data capture

研究概览

简要总结

This is an observational prospective study in a cohort of healthy subjects who are enrolled using convenience and snowballing sampling. The aims of the study is to demonstrate the efficacy of using NeuraLight system to capture oculometric data from healthy participants and to validate the data capture of NeuraLight oculometric measurements as compared with a validated eye-tracker system in subjects who meet the inclusion criteria and who provide a signed Informed Consent.

详细描述

The purpose of the trial is to demonstrate the efficacy of using NeuraLight system to capture oculometric data from healthy participants, and to validate the data capture of NeuraLight oculometric measurements as compared with a validated eye-tracker system. In addition, we also aim to collect oculometric data from healthy participants in order to optimize a regression model which can be used for future prediction of clinical endpoints in various neurological patients at different stages of disease

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women ages between 18 and 90 years old
  • Normal or corrected vision
  • Ability to follow instructions
  • Willing and able to sign an informed consent form

排除标准

  • Inability to sit for 20 minutes on a chair in a calm manner
  • Personal or 1st degree relative history of epilepsy
  • Additional neurological diseases
  • Drug or alcohol abuse

结局指标

主要结局

Efficacy of data capture

时间窗: 36 months

Capturing \>50 different oculometric measures in \>95% of a cohort of up to 2000 subjects

Validation of data capture

时间窗: 36 months

Relative root mean square error (RMSE) of NeuraLight's extracted oculometric measures compared with retrieved measurements from a validated eye tracking system \<0.1

次要结局

  • Optimization of data capture(36 months)

研究者

发起方
NeuraLight
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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