AI Screening for Diabetic Retinopathy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWest German Center of Diabetes and Health

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of diabetes mellitus

Diabetes duration ≥ 5 years

Age > 18 years old

Patient is able to give informed consent

Disqualifiers

History of laser treatment

Contraindication to the fundus imaging systems used in the study

Trial population

Patients of the West German Centre of Diabetes and Health with Type 2 Diabetes

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • artificial intelligence (AI) algorithm of the MONA DR model

    Diagnostic test

    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.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: K+A+1 intervention
Group B: K+A-1 intervention
Group C: K-A+1 intervention
Group D: K-A-1 intervention

Trial outcomes

Primary outcomes

1

PPV

positive predictive value

Time frame
12 months
2

NPV

negative predictive value

Time frame
12 months
3

SEN

sensitivity

Time frame
12 months
4

SPEZ

specificity

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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