NCT07378956Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 23 Jan 2026
- Start date
- 7 Apr 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- VUNO Inc.
- Diseases
- Diabetic eye disease
- NCT number
- NCT07378956
What you commit to
- Study type: Interventional
- Planned participants: 340
- From 7 Apr 2026 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A prior diagnosis of diabetic retinopathy at the time of screening.
- A history of ophthalmic surgery within 6 months prior to the screening date.
Other illness
- A diagnosis of type 1 diabetes mellitus.
- Any condition that, in the opinion of the investigator, would make participation in the study infeasible or inappropriate.
Other
- Pregnancy at the time of screening.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inha University Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.