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
Qualifiers
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
Treatments tested in this trial
- VUNO Med®-Fundus AI™
Treatment groups
340 Participants
are divided into 2 treatment groupsLocations
1Inha University Hospital22332, IncheonGyeonggi-do, South Korea
Sponsors and collaborators
VUNO Inc.
Lead sponsor
Source ClinicalTrials.gov