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

NCT05476523 | Recruiting

• 1 other identifier: HDC/2022-3
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Movement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Optimization of data capture

  36 months

Study Arms (1)

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

Interventions

NeuraLight OTHER

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

Healthy Data Collection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy subjects

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuraLight: lead

Study Sites (1)

NeuraLight

Wilmington, Delaware, 19801, United States

RECRUITING

Study Officials

• Eitan Raveh, PhD

  NeuraLight

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eitan Raveh, PhD

CONTACT

+972-58-6277947; eitan@neuralight.ai

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: July 22, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)