Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners, Using SW as Medical Device (Retina)

Bonmedix Holding a.s.

Status: Enrolling

Conditions: Diabetes Mellitus

Treatments: 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) .

Study type: Interventional

Funder types: Industry

Identifiers

NCT06467903

sukls117945/2024 (Other Identifier)

Retina_01_2024

Details and patient eligibility

About

A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using AI medical device

Full 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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,000 participants in 1 patient group

one arm - 1000 patients, DR screening

Experimental group

Description:

SW as medical devices(investigational device) to evaluate the retinal image of the patient's eye (to identify if the patient has DR or if the patient is healthy) .

Treatment:

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) .