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NCT05704491
AI Screening for Diabetic Retinopathy
Conditions: Diabetes Mellitus
Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: West German Center of Diabetes and Health
Location: Germany
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.
Eligibility Criteria
Inclusion Criteria:Diagnosis of diabetes mellitusDiabetes duration ≥ 5 yearsAge > 18 years oldPatient is able to give informed consentFluent in written and spoken German, or interpreter presentExclusion Criteria:History of laser treatmentContraindication to the fundus imaging systems used in the study
Source: ClinicalTrials.gov (NCT05704491). StuddyBuddy aggregates publicly available trial information.