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Clinical Trials in the USA / NCT07844317
Recruiting Observational

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

NCT07844317 · tracked via the Priya Life Science USA tracker
Sponsor
Digital Diagnostics, Inc
Phase
Observational
Started
2026-08-24
Last updated
2026-09-28

Condition(s) studied

Diabetic Retinopathy (DR)

Investigational drug(s) / intervention(s)

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

SaMD intended for the detection of diabetic retinopathy in adults with diabetes.: No significant difference to other SaMDs for the detection of DR that are commercialized.

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

Study summary

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

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Evaluation of the safety and efficacy of an AI-based SaMD with a fundus camera for the detection of Diabetic Retinopathy — 1-year

Trial sites (1)

FacilityCityRegionStatus
Rovia Site Network Jacksonville Florida Recruiting

More Digital Diagnostics, Inc. trials in the USA

Camera Qualification Study Active, not recruiting

Other trials for the same condition

Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections Enrolling by invitation
RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME) Active, not recruiting
Assessment of AI Program 'DRISTi' as a Screening Tool Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07844317 on ClinicalTrials.gov ↗ ← All trials in the USA