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Clinical Trials/NCT05476523
NCT05476523
Recruiting
N/A

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

NeuraLight1 site in 1 country2,000 target enrollmentJuly 22, 2022
ConditionsEye Movement

Overview

Phase
N/A
Intervention
Not specified
Conditions
Eye Movement
Sponsor
NeuraLight
Enrollment
2000
Locations
1
Primary Endpoint
Efficacy of data capture
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
July 22, 2022
End Date
December 31, 2026
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
NeuraLight
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Efficacy of data capture

Time Frame: 36 months

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

Validation of data capture

Time Frame: 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

Secondary Outcomes

  • Optimization of data capture(36 months)

Study Sites (1)

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