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

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.

Study Overview

• Status: Recruiting
• Conditions: Eye Movement
• Intervention / Treatment: Other: NeuraLight

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

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Eitan Raveh, PhD; Phone Number: +972-58-6277947; Email: eitan@neuralight.ai

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19801
      • Recruiting
      • NeuraLight
      • Contact: Eitan Raveh, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Healthy subjects

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Healthy Data Collection; As a part of the study, a group of up to 2000 healthy subjects will undergo a NeuraLight session including oculometric measurements and eye-tracking recordings using a novel software-based platform and an eye-tracking system (approx. 15 minutes). The oculometric evaluation will occur for every patient 1 time, and all subjects will be recruited over a period of 36 months. All assessments will be performed during a clinic visit unless authorized to be conducted remotely

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of data capture	Capturing >50 different oculometric measures in >95% of a cohort of up to 2000 subjects	36 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NeuraLight
• Investigators: Principal Investigator: Eitan Raveh, PhD, NeuraLight

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HDC/2022-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No