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AI eye exam could save premature Babies' sight

NCT ID NCT06109285

Diagnosis Sponsor: Siloam Vision Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an artificial intelligence system called i-ROP DL that analyzes images of the back of the eye. The goal is to see if it helps eye doctors more accurately diagnose retinopathy of prematurity (ROP), a condition that can cause blindness in premature infants. Researchers will compare doctors' diagnoses with and without the AI tool using about 300 eye images. If it works, this AI could make screening more reliable and accessible.

What this could mean

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

Active substance
i-ROP DL (an artificial intelligence software that analyzes eye images)
What this could lead to
If successful, this AI tool could help doctors detect severe ROP earlier and more accurately, potentially preventing blindness in premature infants.
What could go wrong
This is a small, retrospective study using existing images, not a real-world test. The AI may not perform as well in everyday hospital settings or with different equipment.

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

16 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

20 to 80 years

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: * U.S. board-eligible/board-certified and licensed Medical Doctor, Doctor of Ophthalmology. (American Board of Ophthalmology or equivalent certification) * Signed reader study agreement. * Signed informed consent. * Successful training on the study protocol and the use of the study software Exclusion Criteria: Non - U.S. board-eligible/board-certified and licensed Medical Doctor, Doctor of Ophthalmology. (American Board of Ophthalmology or equivalent certification) * Did not sign reader study agreement. * Did not sign informed consent. * Did not successfully complete training on the study protocol and the use of the study software

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Conditions

The condition(s) this trial relates to.

retinopathy of prematurity

As listed by the trial registrant

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

Retinopathy of prematurity ROP

Contacts and locations

Locations

  • Oregon Health and Sciences University

    Portland, Oregon, 97239, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.