RECRUITINGINTERVENTIONAL
Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners, Using SW as 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
About This Trial
A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using AI medical device
Who May Be Eligible (Plain English)
Who May Qualify:
- Men and women aged ≥ 40 years
- Signed willing to sign a consent form
- Confirmed type 1 or 2 diabetes mellitus
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
SW 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
Locations (1)
Jakub Sedivy
Příbram, Or, Czechia