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Robot eye doctor could save Preemies' sight

NCT ID NCT06517836

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a computer system called i-ROP DL that automatically checks eye images from premature babies for a serious condition called retinopathy of prematurity (ROP), which can cause blindness. Researchers used over 1,200 babies' eye photos from multiple hospitals to see how well the device detects the disease compared to expert doctors. The goal is to make screening faster and more accessible, especially in places without eye specialists.

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 (automated screening device)
What this could lead to
If successful, this device could provide fast, reliable screening for a blinding eye condition in premature babies, reducing the need for specialist exams.
What could go wrong
This is a validation study using existing images, not a real-world test. The device 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

1,284 people

The number who actually took part.

Started

Oct 2024

Finished

Mar 2025

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

4 weeks to 2 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: * Eligible subjects under protocol e-ROP, defined as Infants with birth weight (BW) less than 1251 g meeting current ROP screening. * All examinations will be eligible for inclusion regardless of the e-ROP label for image quality. * Cases are collected during the telemedicine-based remote digital fundus imaging (RDFI-TM) evaluations. Exclusion Criteria: * Postmenstrual age greater than 39 weeks at first opportunity for imaging unless transferred in for ROP treatment. * Admission to a neonatal intensive care unit (NICU) with regressing or treated ROP. * Significant media opacity precluding visualization of the retina. * Major ocular or systemic congenital abnormality.

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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.