AI-assisted retinal photo screening for adults with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares outcomes for adults with type 2 diabetes who receive fundus photography with VUNO Med®-Fundus AI assistance versus usual clinical care without AI. Participants are enrolled at Inha University Hospital and assigned to either an AI-assisted screening pathway or a control pathway, with the primary outcome being the true referral rate for diabetic retinopathy. Key exclusions include a prior diagnosis of diabetic retinopathy, ophthalmic surgery within six months, type 1 diabetes, and pregnancy. The intervention is an AI-SaMD that analyzes fundus photographs and flags images that may require ophthalmology referral.

Why it matters

Who can join: the full rules

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.

Where it's running

• Inha University Hospital
  Incheon, Gyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: Hee Jun Park
• Email: heejun.park@vuno.co
• Phone: 82-10-7101-2844

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.