Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus

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

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.

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.

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.