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RECRUITINGOBSERVATIONAL

AI Screening for Diabetic Retinopathy

Accuracy of an AI Model for Diabetic Retinopathy Screening in Real-life

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosis of diabetes mellitus - Diabetes duration ≥ 5 years - Age \> 18 years old - Patient is able to give willing to sign a consent form - Fluent in written and spoken German, or interpreter present Who Should NOT Join This Trial: - History of laser treatment - Contraindication to the fundus imaging systems used in the study Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * History of laser treatment * Contraindication to the fundus imaging systems used in the study

Treatments Being Tested

DIAGNOSTIC_TEST

artificial intelligence (AI) algorithm of the MONA DR model

A 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.

Locations (1)

West German Center of Diabetes and Health
Düsseldorf, Germany