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Can a simple eye test spot autism in toddlers?

NCT ID NCT06685822

Diagnosis Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This study tested whether a portable eye-tracking device can help diagnose autism in young children in Kenya. 27 children aged 14-72 months watched pictures and videos while the device measured their eye movements. The goal was to see if these eye-tracking patterns match a clinical autism diagnosis. The study is complete and non-invasive.

What this could mean

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

Active substance
Eyelink Portable Duo (eye-tracking device)
What this could lead to
If successful, this could provide a quick, non-invasive tool to help diagnose autism in young children, especially in low-resource settings.
What could go wrong
This is a small, completed study (27 children) and the eye-tracking method may not be as accurate as standard clinical evaluations. Results may not apply to all populations.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

27 people

The number who actually took part.

Started

Nov 2024

Finished

Jun 2025

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.

Ages

14 to 72 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: * Children enrolled in the HEAL-R Autism at MTRH study * Children ages 14-72 months * Caregivers of children must speak Kiswahili (local language) or English. Exclusion Criteria: * Children not enrolled in the HEAL-R Autism at MTRH study * Children younger than 14 months or older than 72 months * Caregivers of children do not speak Kiswahili (local language) or English.

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Conditions

The condition(s) this trial relates to.

autism

As listed by the trial registrant

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

Autism

Contacts and locations

Locations

  • Moi Teaching and Referral Hospital

    Eldoret, Kenya

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