Using AI to screen for diabetic retinopathy in diabetes patients
Accuracy of an AI Model for Diabetic Retinopathy Screening in Real-life
West German Center of Diabetes and Health · NCT05704491
This study is testing if an artificial intelligence tool can accurately spot diabetic retinopathy in people with diabetes by comparing its results to those of eye doctors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | West German Center of Diabetes and Health (other) |
| Locations | 1 site (Düsseldorf) |
| Trial ID | NCT05704491 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of an artificial intelligence algorithm, the MONA-DR-Model, in detecting diabetic retinopathy among patients with diabetes mellitus. Participants will undergo fundus imaging, and the AI's classifications will be compared to those made by resident ophthalmologists as part of routine examinations. The study will assess the algorithm's positive predictive value, negative predictive value, sensitivity, and specificity in identifying diabetic retinopathy. The goal is to determine if AI can provide accurate screenings to improve patient outcomes and facilitate timely referrals for treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a diagnosis of diabetes mellitus for at least 5 years.
Not a fit: Patients with a history of laser treatment or contraindications to the imaging systems used will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and treatment of diabetic retinopathy, potentially preventing vision loss in diabetic patients.
How similar studies have performed: Initial studies have shown promise in using AI for detecting diabetic retinopathy, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * History of laser treatment * Contraindication to the fundus imaging systems used in the study
Where this trial is running
Düsseldorf
- West German Center of Diabetes and Health — Düsseldorf, Germany (RECRUITING)
Study contacts
- Study coordinator: Stephan Martin, MD
- Email: stephan.martin@uni-duesseldorf.de
- Phone: +49-2115660360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus