An interventional study of VUNO Med®-Fundus AI™ in Diabetic Retinopathy (DR), Diabete Mellitus and Fundus Photography, sponsored by VUNO Inc.. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by VUNO Inc. · Not applicable, Interventional, and Screening
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.
The primary objective of this study is to compare the true referral rate between patients with VUNO Med®-Fundus AI™-assisted screening (intervention group) and those receiving usual clinical care without AI assistance (control group) among patients with diabetes mellitus.
772 studies on the registry are indexed under Diabetic Retinopathy; 138 are open to participants now.
This study's planned enrollment of 340 is above the median of 78 across 479 interventional studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →VUNO Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
For participants assigned to the intervention group, VUNO Med®-Fundus AI™ will be applied to the acquired fundus images, and the AI-generated outputs will be shown to clinicians during routine care.
Device: VUNO Med®-Fundus AI™
For participants assigned to the control group, fundus images will be interpreted according to usual clinical care without AI assistance.
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.
True Referral Rate
The true referral rate is defined as the proportion of subjects who were diagnosed with diabetic retinopathy by an ophthalmologist among those referred to ophthalmology with suspected diabetic retinopathy. The true referral rate will be compared between the intervention and control groups.
Time frame: within 6 months
Diabetic Retinopathy (DR) Diagnosis Rate
Proportion of subjects diagnosed with diabetic retinopathy among all enrolled subjects will be compared between the intervention group and the control group.
Time frame: Within 6 months
Odds Ratio
Odds ratio between the diagnosis of diabetic retinopathy and the application of the AI system among subjects referred to ophthalmology will be calculated.
Time frame: Within 6 months
Referral Rate
Proportion of subjects referred to ophthalmology for suspected diabetic retinopathy among all enrolled subjects will be compared between the intervention group and the control group.
Time frame: Within 6 months
Time to Diabetic Retinopathy Diagnosis
Time interval from the diagnosis of diabetes mellitus to confirmed diagnosis of diabetic retinopathy based on ophthalmologic evaluation among referred subjects will be compared between the intervention group and the control group.
Time frame: Within 6 months
Performance of the AI System in Detecting Diabetic Retinopathy
Sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) of the AI system will be calculated in comparison with ophthalmologist-confirmed diagnoses.
Time frame: Within 6 months
Accuracy of Referral for Diabetic Retinopathy
Proportion of subjects whose referral decisions (referral or non-referral) are concordant with ophthalmologist-confirmed DR status will be compared between the intervention group and the control group.
Time frame: Within 6 months
Adherence Rate
Proportion of referred subjects who attend an ophthalmology department will be compared between the intervention group and the control group.
Time frame: Within 6 months
Interim Analysis
One interim analysis will be conducted when 50% of subjects have completed all study visits. The purpose of this analysis is to review the status of subject dropouts and the reasons for dropout in each group. This procedure will be conducted by a statistician who is independent of the study conduct.
Time frame: Within 6 months
Plan to share: Yes — The institutional dataset used in this study, along with de-identified results, is available upon reasonable request for purposes such as systematic review or meta-analysis, only with approval from the corresponding author and the official approval of local IRB.
Supporting information: Study protocol, Sap, Icf
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