AI-based Early Detection of Diabetic Retinopathy (FUNDUS AI)

University Hospital Tuebingen

Status: Invitation-only

Conditions: Prediabetes; Diabetes (DM)

Study type: Observational

Funder types: Other

Identifiers

NCT07378891

419/2025BO2

Details and patient eligibility

About

Examination of individuals with prediabetes and established diabetes for early signs of diabetic retinopathy.

Full description

Fundus images are acquired and analyzed using an AI algorithm. The fundus images are captured using two devices: a stationary fundus camera (CenterVue DRSplus) and the Optomed Aurora IQ handheld fundus camera. Retinal images are examined using AI-based image analysis.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voluntary adults
• Aged between 18 and 80 years
• Understanding of the study explanations and instructions
• Prediabetes (defined by elevated fasting glucose 100-125 mg/dL and/or 2-hour glucose in the oral glucose tolerance test of 140-199 mg/dL and/or HbA1c of 5.7-6.4%)
• manifest diabetes (all types of diabetes according to Ahlqvist)

Exclusion criteria

• participants unable to give consent
• Those who do not agree to be informed about incidentally detected pathological findings
• Uncontrolled arterial hypertension (Stage III) despite multiple antihypertensive medications
• Eye diseases that impair the interpretability of the fundus examination

Trial design

100 participants in 1 patient group

Prediabetes and Diabetes

Description:

Participants with prediabetes and diabetes