Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diab
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.
| Condition(s) | Diabetic Retinopathy (DR), Diabete Mellitus, Fundus Photography |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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. |
| Ages | 19 Years |
| Sex | All |
| Lead sponsor | VUNO Inc. |
| Locations | Incheon, Gyeonggi-do, South Korea |
| Start date | 2026-04-07 |
| NCT ID | NCT07378956 |
| Official listing | https://clinicaltrials.gov/study/NCT07378956 |