About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of diabetes mellitus
Diabetes duration ≥ 5 years
Age > 18 years old
Patient is able to give informed consent
Disqualifiers
History of laser treatment
Contraindication to the fundus imaging systems used in the study
Trial population
Patients of the West German Centre of Diabetes and Health with Type 2 Diabetes
Trial design
Case-control
Other
Treatments tested in this trial
artificial intelligence (AI) algorithm of the MONA DR model
Diagnostic testA 45-degree fundus image is taken for each eye and patient using the Crystalvue NFC 600. The fundus photographs are then analyzed using the MONA DR model and classified for presence of diabetic retinopathy.
Treatment groups
Trial outcomes
Primary outcomes
PPV
positive predictive value
NPV
negative predictive value
SEN
sensitivity
SPEZ
specificity
Sponsors and contacts
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