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

June 20, 2024 updated by: Bonmedix Holding a.s.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • Or
      • Příbram, Or, Czechia
        • Recruiting
        • Jakub Sedivy
        • Contact:
          • Sedivy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: one arm - 1000 patients, DR screening
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) .
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bonmedix Holding a.s.

Investigators

  • Principal Investigator: Petr Šonka, MD, GP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2024

Primary Completion (Estimated)

October 28, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Retina_01_2024
  • sukls117945/2024 (Other Identifier: SUKL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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