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AI eye exam: could a computer beat your doctor at spotting diabetic blindness?

NCT ID NCT04132401

Diagnosis Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tested an artificial intelligence (AI) algorithm to detect diabetic retinopathy and glaucoma from eye photos. Researchers compared the AI's accuracy to that of family doctors and retina specialists. The goal was to see if AI could be a reliable screening tool in primary care for people with diabetes.

What this could mean

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

Active substance
Artificial intelligence algorithm
What this could lead to
If successful, this AI could help screen for diabetic eye disease more quickly and accurately in primary care, potentially preventing blindness.
What could go wrong
This is a completed study comparing AI to doctors, not a treatment trial. The AI may not perform as well in real-world settings or with different patient groups.

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

902 people

The number who actually took part.

Started

May 2021

Finished

Sep 2023

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.

Who is studied

Adults with a clinical diagnosis of type 1 or type 2 diabetes mellitus attending primary care centres who underwent fundus photography as part of a diabetic retinopathy screening programme. The retinal images obtained were assessed for diabetic retinopathy and other central-involved retinal pathologies and glaucoma.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Clinical diagnosis of type II diabetes mellitus * Fundus photograph taken as part of the screening for diabetic retinopathy Exclusion Criteria: * patients with glaucoma under treatment * patients with advanced dementia who do not collaborate in taking photographs * patients with significant deafness who cannot follow the instructions for taking photographs * patients with mobility problems (wheelchairs, important kyphosis) or tremor who cannot take photographs * patients with pathologies that interfere with the quality of images such as cataracts, nystagmus, corneal leucoma or corneal transplants.

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration diabetic retinopathy glaucoma macular degeneration preretinal fibrosis type 2 diabetes mellitus

As listed by the trial registrant

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

Age-related macular degeneration Choroidal nevus Diabetic retinopathy Epiretinal membrane Glaucoma

Contacts and locations

Locations

  • CAP Bages

    Manresa, Barcelona, 08242, Spain

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