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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
West German Center of Diabetes and Health
RECRUITING
Düsseldorf
Contact Information
Primary
Stephan Martin, MD
stephan.martin@uni-duesseldorf.de
+49-2115660360
Backup
Kerstin Kempf, PhD
kerstin.kempf@wdgz.de
+49-2115660360
Time Frame
Start Date: 2023-01-30
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
K+A+
diabetic retinopathy according to AI present (K+) AND diabetic retinopathy according to the doctor present (A+)
K+A-
diabetic retinopathy according to AI present (K+) AND diabetic retinopathy according to the doctor absent (A-)
K-A+
diabetic retinopathy according to AI absent (K-) AND diabetic retinopathy according to the doctor present (A+)
K-A-
diabetic retinopathy according to AI absent (K-) AND diabetic retinopathy according to the doctor absent (A-)
Related Therapeutic Areas
Sponsors
Leads: West German Center of Diabetes and Health

This content was sourced from clinicaltrials.gov