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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Republic of Korea
Inha University Hospital
RECRUITING
Incheon
Contact Information
Primary
Hee Jun Park
heejun.park@vuno.co
82-10-7101-2844
Time Frame
Start Date: 2026-04-07
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 340
Treatments
Experimental: Intervention group
For participants assigned to the intervention group, VUNO Med®-Fundus AI™ will be applied to the acquired fundus images, and the AI-generated outputs will be shown to clinicians during routine care.
No_intervention: Control group
For participants assigned to the control group, fundus images will be interpreted according to usual clinical care without AI assistance.
Related Therapeutic Areas
Sponsors
Leads: VUNO Inc.