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NOT YET RECRUITING
NCT07378956
NA

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

Sponsor: VUNO Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: Clinical Efficacy of Implementing an AI-Driven Software as a Medical Device (SaMD) for Funduscopy Analysis in Patients With Diabetes Mellitus: A Randomized Controlled Trial Protocol

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2026-02-20

Completion Date

2027-08-31

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

DEVICE

VUNO Med®-Fundus AI™

VUNO Med®-Fundus AI™ is an artificial intelligence-based fundus image detection and diagnostic support software. The software automatically identifies abnormal retinal findings and provides information on the type and location of detected abnormalities to aid clinical decision-making.