Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT07378956

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

Led by VUNO Inc. · Updated on 2026-04-13

340

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Prior diagnosis of diabetic retinopathy at the time of screening
  • History of ophthalmic surgery within 6 months prior to the screening date
  • Diagnosis of type 1 diabetes mellitus
  • Pregnancy at the time of screening
  • Any condition that would make participation infeasible or inappropriate in the investigator's opinion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Inha University Hospital

Incheon, Gyeonggi-do, South Korea, 22332

Actively Recruiting

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Research Team

H

Hee Jun Park

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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