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RECRUITING
NCT05704491

AI Screening for Diabetic Retinopathy

Sponsor: West German Center of Diabetes and Health

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2023-01-30

Completion Date

2025-12-31

Last Updated

2024-07-11

Healthy Volunteers

No

Interventions

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