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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus
• Interventions: 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) .

• Registration Number: NCT06467903
• Lead Sponsor: Bonmedix Holding a.s.

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

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-07
• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-20
• Last Update Submitted: 2024-06-20
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Primary Completion: 2024-10-28
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one arm - 1000 patients, DR screening	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) .	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) .

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity	3 months	The sensitivity and specificity will be calculated using the evaluation of independent masked expert (ophthalmologist) as gold standard.

Trial Locations

Locations (1)

Jakub Sedivy; 🇨🇿 Příbram, Or, Czechia