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

NCT ID NCT06343350

Completed Diagnosis Sponsor: Optain Health Source: ClinicalTrials.gov ↗

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.

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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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