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Can a simple eye-tracking test spot autism in babies before their first birthday?

NCT ID NCT05916430

Diagnosis Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a portable eye-tracking device can accurately screen 9-month-old infants for autism spectrum disorder (ASD). Over 2,000 babies will watch short videos while cameras track their eye movements. Researchers will then compare these results with standard autism diagnoses made at 24 months. If the device works well, it could lead to much earlier detection and support for children with autism.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EarliPoint Investigational Device (eye-tracking test)
What this could lead to
If successful, this could enable routine, objective autism screening in infants as young as 9 months, allowing earlier support and intervention.
What could go wrong
The trial is still recruiting and results are not yet available. The eye-tracking test may not be accurate enough to replace current diagnostic methods, and early screening could cause unnecessary worry or false positives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Infants presenting for a 9-month well-child visit between the chronological ages of 8-10 months with no acute illnesses

Ages

8 to 10 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infants between the chronological ages of 8-10 months * Infants must be generally healthy with no acute illnesses likely to prevent successful or valid data collection (e.g., current vomiting, high fever, conjunctivitis affecting vision) * Participants' parents/caregivers must be able to understand and voluntarily provide written informed consent. Exclusion Criteria: \- Children will be excluded if they have signs of acute illness likely to prevent successful or valid data collection (e.g., conjunctivitis affecting vision, current vomiting, or high fever).

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Conditions

The condition(s) this trial relates to.

autism Autism Spectrum Disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism Infant development

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30329, United States

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