Artificial-Intelligence-based Early Detection of Diabetic Retinopathy (FUNDUS AI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetes (DM), Prediabetes. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Künstliche Intelligenz (KI)-gestützte Früherkennung Der Diabetischen Retinopathie (FUNDUS-KI)
Overview
Examination of individuals with prediabetes and established diabetes for early signs of diabetic retinopathy.
Detailed 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.
Primary outcome measures
- Assessment of retinal changes [Time frame: Day 1]
Secondary outcome measures (3)
- Image quality and comparison of the fundus cameras [Time frame: Day 1]
- Influence of clinical parameters on retinal vascular changes [Time frame: Day 1]
- Association of medications with the ocular fundus [Time frame: Day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Hospital Tuebingen, Dep. Diabetology — Tübingen
Identifiers
NCT: NCT07378891 · 419/2025BO2