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

Study 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

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

Conditions
-----------------
Eye Movement

Intervention / Treatment
-----------------
* Other: NeuraLight


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Data Collection<br>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<br>* NeuraLight is an investigational software-based platform used for measuring eye movements in response to visual stimuli and captured using a simple webcam<br>|

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 |