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NCT05704491 · ClinicalTrials.gov record · last posted 2026-08-10

AI Screening for Diabetic Retinopathy

Study acronym: AimdR
StatusRecruiting
PhaseNot specified
Started2023-01-30
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-08-11
notable
Trial status changed: Unknown → Recruiting
2026-08-11
critical
Primary completion pushed: 2024-12-31 → 2027-12-31
2026-08-11
minor
Completion pushed: 2025-12-31 → 2027-12-31
2026-08-02
minor
Trial status changed: Recruiting → Unknown
Trial Details
NCT Number NCT05704491
Lead Sponsor West German Center of Diabetes and Health
Conditions Diabetes Mellitus
Enrollment 100 participants
Start Date 2023-01-30
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-10