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

RECRUITINGN/ASponsored by VUNO Inc.
Actively Recruiting
PhaseN/A
SponsorVUNO Inc.
Started2026-04-07
Est. completion2027-08-31
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07378956

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.

Eligibility

Age: 19 Years+Healthy volunteers accepted
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.

Conditions4

Diabete MellitusDiabetesDiabetic Retinopathy (DR)Fundus Photography

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