Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus

Recruiting now · Not applicable

Conditions studied: Diabetic Retinopathy (DR), Diabete Mellitus, Fundus Photography

In brief

The objective of this study is to investigate the efficacy of implementing the AI-SaMD(VUNO Med®-Fundus AI™) alongside routine clinical practice for the detection of diabetic retinopathy.

Key facts

Study ID

NCT07378956

Run by

VUNO Inc.

People needed

340

Starts

2026-04-07

Expected to finish

2027-08-31

Last updated by the study team

2026-04-13

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 19 years or older.
• A documented diagnosis of type 2 diabetes mellitus.
• Ability to communicate adequately and provide written informed consent for participation in the study.

You may not qualify if…

• A prior diagnosis of diabetic retinopathy at the time of screening.
• A history of ophthalmic surgery within 6 months prior to the screening date.
• A diagnosis of type 1 diabetes mellitus.
• Pregnancy at the time of screening.
• Any condition that, in the opinion of the investigator, would make participation in the study infeasible or inappropriate.

Where it is running

• Inha University Hospital — Incheon, Gyeonggi-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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