Diabetes Mellitus
Conditions
Brief summary
A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using AI medical device
Detailed description
A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using the SWaMD medical device and the SWaMD comparator, when evaluating the patients retinal image
Interventions
DEVICESW as medical devices(comperator) to evaluate the retinal image of the patient's eye (to identify if the patient has DR or if the patient is healthy) .
second AI medical device to evaluate the retinal image of the patient's eye. two AI as MD will be evaluating the retinal image
Sponsors
Bonmedix Holding a.s.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
specific screening exhamination
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity | 3 months | The sensitivity and specificity will be calculated using the evaluation of independent masked expert (ophthalmologist) as gold standard. |
Countries
Czechia
Contacts
Primary ContactPavlina Kasparova Walter, MBA
Backup ContactJiří Tomšej, ING
Outcome results
None listed