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

Eye Movement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05476523
• Other study ID #: HDC/2022-3
• Status: Recruiting
• Start date: July 22, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: NeuraLight
• Contact: Eitan Raveh, PhD
• Phone: +972-58-6277947
• Email: eitan[@]neuralight.ai
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Eye Movement

Intervention

Other:
• NeuraLight
NeuraLight is an investigational software-based platform used for measuring eye movements in response to visual stimuli and captured using a simple webcam

Locations

Country	Name	City	State
United States	NeuraLight	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
NeuraLight

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of data capture	Capturing >50 different oculometric measures in >95% of a cohort of up to 2000 subjects	36 months
Primary	Validation of data capture	Relative root mean square error (RMSE) of NeuraLight's extracted oculometric measures compared with retrieved measurements from a validated eye tracking system <0.1	36 months
Secondary	Optimization of data capture	Optimization of a feature selection model (Fisher's Linear Discriminant Analysis (LDA)) on NeuraLight oculometric measures used for a logistic regression model of clinical endpoints with a relative root mean square error (RMSE) of <0.1	36 months