Overview
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.
Description
The primary objective of this study is to compare the true referral rate between patients with VUNO Med®-Fundus AI™-assisted screening (intervention group) and those receiving usual clinical care without AI assistance (control group) among patients with diabetes mellitus.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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, in the opinion of the investigator, would make participation in the study infeasible or inappropriate.
