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New AI eye screening tool could help millions with diabetes avoid blindness

NCT ID NCT06343350

Diagnosis Sponsor: Optain Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 software called OPTDR01 that automatically checks retinal images for signs of diabetic retinopathy, a leading cause of vision loss. Researchers enrolled 300 adults with diabetes to see if the tool is easy to use and practical in a clinic setting. The goal is to make screening more available in primary care, especially for underserved groups who often miss annual eye exams.

What this could mean

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

Active substance
OPTDR01 software application
What this could lead to
If successful, this tool could make diabetic retinopathy screening more accessible in primary care, helping catch the disease early and prevent vision loss.
What could go wrong
This is a small pilot study focused on usability and feasibility, not on clinical outcomes. The tool may not be accurate enough or practical for widespread use.

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

300 people

The number who actually took part.

Started

Apr 2024

Finished

Oct 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.

Who is studied

Patients diagnosed with Type I or Type II diabetes that are eligible for Diabetic Retinopathy screening

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA): 2. Age 22 or older 3. Understand the study and volunteer to sign the informed consent Exclusion Criteria: 1. Unable to understand the study 2. Unwilling to sign informed consent 3. Indicate persistent vision loss, blurred vision, or floaters 4. Previous diagnosis of macular edema, diabetic retinopathy (any level) proliferative retinopathy, radiation retinopathy, or retinal vein occlusion 5. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery 6. Currently participating in another investigational eye study or actively receiving investigational product for diabetic retinopathy or diabetic macular edema 7. A condition that, in the opinion of the investigator, would preclude participation in the study 8. 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 9. Known pregnancy

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic retinopathy

As listed by the trial registrant

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

Diabetes Diabetic retinopathy

Contacts and locations

Locations

  • Gastro SB

    Chula Vista, California, 91910, United States

  • Gulf Coast Clinical Research

    Houston, Texas, 77070, United States

  • Triwest Research Associates

    San Diego, California, 92108, United States

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