Capturing diabetic retinopathy patients using an AI medical device
A Prospective, Comparative Multicenter Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners, Using the SW as Medical Device and the SW as MD Comparator, When Evaluating the Patient's Retinal Image
This study tests whether an AI device can help doctors find diabetic retinopathy in people with diabetes more effectively than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Bonmedix Holding a.s. Industry-sponsored |
| Locations | 1 site (Příbram, Or) |
| Trial ID | NCT06467903 on ClinicalTrials.gov |
What this trial studies
This evaluation aims to identify patients with diabetic retinopathy (DR) by utilizing an AI medical device in a multicenter setting. General practitioners will use the SWaMD device to analyze retinal images and determine the presence of DR in individuals with diabetes mellitus. The study is prospective and comparative, focusing on the effectiveness of the device in real-world clinical settings. By comparing the results from the SWaMD device with standard evaluation methods, the study seeks to enhance early detection and management of DR.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 40 years and older with confirmed type 1 or type 2 diabetes mellitus.
Not a fit: Patients with ocular conditions that prevent retinal photography or those with legal restrictions on personal freedom may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of diabetic retinopathy, potentially preventing vision loss in diabetic patients.
How similar studies have performed: Other studies utilizing AI for the detection of diabetic retinopathy have shown promising results, indicating that this approach is gaining traction in the medical field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged ≥ 40 years * Signed informed consent * Confirmed type 1 or 2 diabetes mellitus Exclusion Criteria: * Ocular findings that do not allow retinal photography (significant nystagmus, corneal leukoma, dense cataract, hemophthalmus, etc.) * Patient has a condition or is in a situation that, in the opinion of the investigator, may bias the results of the study, may significantly interfere with the patient's participation in the investigation, or may result in unproducible photographs of a dilated ocular fundus * Patients with restrictions on personal freedom by administrative or legal order
Where this trial is running
Příbram, Or
- Jakub Sedivy — Příbram, Or, Czechia (Recruiting)
Study contacts
- Principal investigator: Petr Šonka, MD — Gp
- Study coordinator: Pavlina Kasparova Walter, MBA
- Email: pavlinakasparova@gmail.com
- Phone: 776661512
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.