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NCT06467903 Clinical Trial

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

Diabetes Mellitus Clinical Trial

— Retina  

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06467903
Other study ID # Retina_01_2024
Secondary ID sukls117945/2024
Status Recruiting
Phase N/A
First received
Last updated
Start date June 7, 2024
Est. completion date December 15, 2024

Study information
Verified date June 2024
Source Bonmedix Holding a.s.
Contact Pavlina Kasparova Walter, MBA
Phone 776661512
Email pavlinakasparova@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 15, 2024
Est. primary completion date October 28, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
Country Name City State
Czechia Jakub Sedivy Príbram Or

Sponsors (1)
Lead Sponsor Collaborator
Bonmedix Holding a.s.

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity The sensitivity and specificity will be calculated using the evaluation of independent masked expert (ophthalmologist) as gold standard. 3 months
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