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AI eye scanner could prevent blindness in millions with diabetes

NCT ID NCT07151001

Diagnosis Sponsor: iHealthScreen Inc 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests an artificial intelligence system called iPredict-DR that analyzes retinal photos to detect diabetic retinopathy, a leading cause of blindness. Researchers will enroll 922 adults with diabetes at primary care and endocrinology clinics. The AI's accuracy will be compared against human experts to see if it can reliably identify early signs of eye damage.

What this could mean

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

Active substance
iPredict-DR AI software
What this could lead to
If successful, this AI tool could allow routine screening for diabetic eye disease in primary care clinics, catching it early before vision loss occurs.
What could go wrong
This is a pivotal trial, but the AI must prove it matches expert ophthalmologists. If accuracy falls short, it may not be adopted widely.

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 922 people

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

Started

Jan 2025

Expected to finish

Jul 2027

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.

Who is studied

Study subjects will be enrolled at primary care practices (internal medicine clinics, endocrinology clinics).

Ages

22 years and older

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: * Age of Subjects: Patients ≥ 22 years of age. * Gender of Subjects: Both males and females will be invited to participate. * Subjects with diabetes (A1C level ≥ 6.5). * Subjects must be willing and are able to comply with clinic visit, understand the study-related procedures/provisions, and provide signed informed consent. Exclusion Criteria: * Unable to understand the study, Our unable to or unwilling to sign the informed consent * Previously diagnosed with macular edema, any form of diabetic retinopathy, radiation retinopathy, or retinal vein occlusion * participants who are experiencing persistent vision loss, blurred vision, or other vision problems that should be evaluated by an eye care provider * subjects whose retinal images were used in training, validating, or developing the device * Currently participating in another investigational eye study or actively receiving investigational product for DR or DME. * A condition that, in the opinion of the investigator, would preclude participation in the study; * Contraindicated for imaging by fundus imaging systems used in the study because of hypersensitivity to light, recently underwent photodynamic therapy, or was taking medication that causes photosensitivity.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic retinopathy disease

As listed by the trial registrant

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

Diabetes Diabetic retinopathy

How to take part

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

  1. The places running it

    1 site. 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

  • iHealthScreen Inc.

    RECRUITING

    Richmond Hill, New York, 11418, United States

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