Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners, Using SW as Medical Device
Retina
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
2 other identifiers
interventional
1,000
1 country
1
Brief Summary
A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using AI medical device
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Jun 2024
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2024
CompletedFirst Submitted
Initial submission to the registry
June 10, 2024
CompletedFirst Posted
Study publicly available on registry
June 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedJune 21, 2024
June 1, 2024
5 months
June 10, 2024
June 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity
The sensitivity and specificity will be calculated using the evaluation of independent masked expert (ophthalmologist) as gold standard.
3 months
Study Arms (1)
one arm - 1000 patients, DR screening
EXPERIMENTALSW 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) .
Interventions
second AI medical device to evaluate the retinal image of the patient's eye. two AI as MD will be evaluating the retinal image
Eligibility Criteria
You may qualify if:
- Men and women aged ≥ 40 years
- Signed informed consent
- Confirmed type 1 or 2 diabetes mellitus
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jakub Sedivy
Příbram, Or, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petr Šonka, MD
GP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2024
First Posted
June 21, 2024
Study Start
June 7, 2024
Primary Completion
October 28, 2024
Study Completion
December 15, 2024
Last Updated
June 21, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share