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

Recruiting

• Conditions: Eye Movement
• Interventions: Other: NeuraLight

• Registration Number: NCT05476523
• Lead Sponsor: NeuraLight

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

Study Timeline

• Study Start: 2022-07-22
• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Data Collection	NeuraLight	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

Primary Outcome Measures

Name	Time	Method
Efficacy of data capture	36 months	Capturing \>50 different oculometric measures in \>95% of a cohort of up to 2000 subjects
Validation of data capture	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 Outcome Measures

Name	Time	Method
Optimization of data capture	36 months	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

Trial Locations

Locations (1)

NeuraLight; 🇺🇸 Wilmington, Delaware, United States