Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening
ARTDR
1 other identifier
observational
200
1 country
1
Brief Summary
To examine the potential for the detection of diabetic retinopathy (DR) using the artificial intelligence (AI)-based software platform Retina-AI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
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
November 2, 2024
CompletedFirst Submitted
Initial submission to the registry
March 11, 2025
CompletedFirst Posted
Study publicly available on registry
March 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 17, 2025
March 1, 2025
9 months
March 11, 2025
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The accuracy
The accuracy of detecting of DR
Baseline
Secondary Outcomes (2)
The percent of invalid images
Baseline
The percent of false positive detection of DR
Baseline
Study Arms (2)
main group
have diabetes mellitus
control group
have risk factors for developing diabetes mellitus
Interventions
using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.
Eligibility Criteria
200 participants were planed to include in study, 100 of them had diabetes mellitus and 100 participants were as a control group have risk factors for diabetes mellitus. All participants were selected for the study based on the following inclusion and exclusion criteria
You may qualify if:
- Documented diagnosis of diabetes mellitus by definition.
- Understanding of the Study and willingness and ability to sign informed consent
- Patient age 18 or above
- Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes
You may not qualify if:
- Patients under 18 years of age; 2. Failure to give informed consent; 3. Presence of retinal diseases - acquired disease: age-related macular degeneration (AMD), occlusion of retinal vessels (ORV), etc.; birth defects: coloboma of choroid or optic nerve disc, etc.; hereditary diseases: retinitis pigmentosa, angioid streaks of the retina, etc.
- \. A patient who has already undergone treatment (surgery, laser, etc.) for any disease of the retina: age-related macular degeneration (AMD), retinal vascular occlusion (ARV), etc. These patients should be excluded or allocated to a separate group.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Filatov Institute of Eye Diseases and Tissue Therapylead
- CheckEye LLCcollaborator
- Oftacentro SAcollaborator
Study Sites (1)
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, 65061, Ukraine
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrii MD Korol, PhD
The Filatov Institute of Eye Diseases and Tissue Therapy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, DMedSc,Prof
Study Record Dates
First Submitted
March 11, 2025
First Posted
March 17, 2025
Study Start
November 2, 2024
Primary Completion
August 1, 2025
Study Completion
December 1, 2025
Last Updated
March 17, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share