NCT05704491Recruiting
AI Screening for Diabetic Retinopathy
Accuracy of an AI Model for Diabetic Retinopathy Screening in Real-life
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
The increasing prevalence of diabetes mellitus represents a major health problem, especially since around 40% of diabetic patients develop diabetic retinopathy, which severely impairs vision and can lead to blindness. This development could be prevented by annual check-ups and timely referral for treatment. However, there are major differences in the quality of examinations and bottlenecks in examination appointments. A solution to the problem could be the use of artificial intelligence (AI), especially deep learning. Initial studies have shown that deep learning algorithms can be used successfully to detect diabetic retinopathy. However, it remains to be clarified whether the use of AI can achieve a sufficiently high level of accuracy in the detection of retinopathies. Therefore, in the present study, the positive predictive value (PPV), the negative predictive value (NPV), the sensitivity (SEN) and the specificity (SPEZ) of the AI algorithm 'MONA-DR-Model' in the detection of diabetic retinopathy should be measured. In addition, it is to be examined how well the classification into mild and severe retinopathy corresponds and how well this new examination method is accepted by the patients.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 19 Jan 2023
- Start date
- 30 Jan 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- West German Center of Diabetes and Health
- Diseases
- Diabetic eye disease
- NCT number
- NCT05704491
What you commit to
- Study type: Observational
- Planned participants: 100
- From 30 Jan 2023 to the primary completion date, 31 Dec 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.
Other illness
- History of laser treatment
Other
- Contraindication to the fundus imaging systems used in the study
Who the study is looking for
- Diagnosis of diabetes mellitus
- Diabetes duration ≥ 5 years
- Age \> 18 years old
- Patient is able to give informed consent
- Fluent in written and spoken German, or interpreter present
Age in the registry: 18 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 |
|---|---|---|---|
| West German Center of Diabetes and Health Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.