Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus
Recruiting
N/A
Interventional Study
Diabetic Retinopathy (DR)
Diabete Mellitus
Fundus Photography
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Screening
- Participants needed
- 340 (estimated)
- Sponsor
- VUNO Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 screen…
Contacts