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Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy

A Multicenter, Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Automated System for Detecting Diabetic Retinopathy Using a Fundus Camera

Who can join

Ages 22 and older · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* 22 years of age or older
* Diagnosis of DM
* Ability to understand and willing to sign a written ICF

Exclusion Criteria:

Participants may be excluded if they have significant ocular conditions or prior ocular treatments that could interfere with retinal imaging or study assessments; are currently participating in another interventional ophthalmic clinical trial; have medical conditions that may affect study participation or data interpretation; are pregnant; or have contraindications to study-related imaging procedures.

About the study

Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.

What is being tested

• SaMD intended for the detection of diabetic retinopathy in adults with diabetes. (device)
• An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes. (device)

Sponsor: Digital Diagnostics, Inc. · Participants: 800 · Started: Aug 24, 2026

Contact the study team

• Audrey Singh Singh · Phone: 7633702127

Official record on ClinicalTrials.gov — NCT07844317

Locations in the U.S.

Conditions

• Diabetic Eye Problems

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.