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

RecruitingNAAges 19 Years - anyAllVUNO Inc.
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • VUNO Med®-Fundus AI™
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Where

1 site
Inha University Hospital
Incheon, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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