Actively Recruiting
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
Led by VUNO Inc. · Updated on 2026-04-13
340
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of an artificial intelligence software called VUNO Med4-Fundus AI12 to assist in analyzing fundus images for diabetic retinopathy detection in patients with type 2 diabetes mellitus. The study aims to see how effective this AI tool is compared to routine clinical care without AI assistance in identifying patients who need referral for diabetic retinopathy. This is a randomized controlled trial led by VUNO Inc. focusing on improving diabetes eye care through technology. Participants will be randomly assigned to one of two groups. Those in the intervention group will have their fundus images analyzed using the VUNO Med4-Fundus AI12 software, and the AI results will be shared with clinicians during routine care. The control group will receive usual clinical care without the use of AI assistance. The study measures outcomes within 6 months, including true referral rates and other diagnostic performance indicators. During the study, participants will undergo fundus photography as part of their routine care, with or without AI support depending on their group. Researchers will monitor how accurately diabetic retinopathy is detected, the time to diagnosis, referral rates, and adherence to recommendations. Data will be collected over a 6-month period to assess the impact of AI assistance in clinical decision-making for diabetic retinopathy referral. The total study duration extends until August 2027.
CONDITIONS
Brief 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...
- 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
- Any condition that would make participation in the study infeasible or inappropriate in the opinion of the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months
Participants who undergo routine care are observed with or without the use of the AI software for fundus image analysis to evaluate referral rates and diabetic retinopathy diagnosis.
Trial Site Locations
Total: 1 location
1
Inha University Hospital
Incheon, Gyeonggi-do, South Korea, 22332
Actively Recruiting
Research Team
H
Hee Jun Park
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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