Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes
Sponsor: VUNO Inc.
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.
Official title: Clinical Efficacy of Implementing an AI-Driven Software as a Medical Device (SaMD) for Funduscopy Analysis in Patients With Diabetes Mellitus: A Randomized Controlled Trial Protocol
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2026-02-20
Completion Date
2027-08-31
Last Updated
2026-02-10
Healthy Volunteers
No
Interventions
VUNO Med®-Fundus AI™
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.