An observational study in Diabetic Retinopathy (DR), sponsored by Digital Diagnostics, Inc.. Recruiting at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Digital Diagnostics, Inc. · Observational
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
Diabetic adult population with no previous diagnosis of DR
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.
Adult, 22 years or older with a diagnosis of diabetes
Device: 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.
No significant difference to other SaMDs for the detection of DR that are commercialized.
SaMD to detect diabetic retinopathy
Also known as: AI/ML, SaMD
Evaluation of the safety and efficacy of an AI-based SaMD with a fundus camera for the detection of Diabetic Retinopathy
Time frame: 1-year
Plan to share: No
No publications or documents are linked to this record.
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Digital Diagnostics, Inc.