Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorVUNO Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
VUNO Med®-Fundus AI™
DeviceVUNO 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.
Treatment groups
340 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsOther outcomes
1
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 monthsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Inha University HospitalRecruiting22332, Incheon, Gyeonggi-doSouth Korea
Source ClinicalTrials.gov