Eye MovementNCT05476523
Development and Validation of a Novel Eye-Tracking Software-based Platform to Extract Oculometric Measures
An observational study of Eye Movement, run by NeuraLight at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Eye Movement
- What is being tested?
- NeuraLight
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Healthy subjects
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NeuraLight
Wilmington, Delaware, 19801
Eitan Raveh, PhD
About this study
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.
Read the 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
- Conditions
- Eye Movement
- Being tested
- NeuraLight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuraLightOther
NeuraLight is an investigational software-based platform used for measuring eye movements in response to visual stimuli and captured using a simple webcam
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: NeuraLight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of data capture
Capturing >50 different oculometric measures in >95% of a cohort of up to 2000 subjects
Measured: 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
Measured: 36 months
Secondary outcomes (1)
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start22 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye MovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuraLight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eitan Raveh, PhD, Principal investigator, NeuraLight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476523
- Sponsor's protocol ID
- HDC/2022-3
- Status last verified
- May 2025
- First submitted
- 25 Jul 2022
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Novel Eye-Tracking Software-based Platform to Extract Oculometric Measures
- ClinicalTrials.gov ID
- NCT05476523
- Acronym / sponsor ID
- HDC/2022-3
- Conditions
- Eye Movement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- NeuraLightIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Data Collection | – | Other: NeuraLightAs 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuraLightNeuraLight is an investigational software-based platform used for measuring eye movements in response to visual stimuli and captured using a simple webcam | Other | Healthy Data Collection |
Primary outcome
Efficacy of data capture
Time frame: 36 months
Capturing >50 different oculometric measures in >95% of a cohort of up to 2000 subjects
Validation of data capture
Time frame: 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
1 secondary outcome
Optimization of data capture
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eitan Raveh, PhD principal investigator
NeuraLight
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Movement, run by NeuraLight at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eitan Raveh, PhD (+972-58-6277947, eitan@neuralight.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of data capture (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.