Actively Recruiting
Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus
Led by VUNO Inc. · Updated on 2026-04-13
340
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Prior diagnosis of diabetic retinopathy at the time of screening
- History of ophthalmic surgery within 6 months prior to the screening date
- Diagnosis of type 1 diabetes mellitus
- Pregnancy at the time of screening
- Any condition that would make participation infeasible or inappropriate in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Inha University Hospital
Incheon, Gyeonggi-do, South Korea, 22332
Actively Recruiting
Research Team
H
Hee Jun Park
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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