Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening (ARTDR)

March 11, 2025 updated by: Andrii Korol, MD, PhD, The Filatov Institute of Eye Diseases and Tissue Therapy
To examine the potential for the detection of diabetic retinopathy (DR) using the artificial intelligence (AI)-based software platform Retina-AI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Operator took fundus images with a non-mydriatic fundus camera as per the Retina-AI CheckEye imaging protocol (an optic disc centered image and a fovea centered image for each eye).Thereafter, operator uploaded fundus images in the AI system for processing by the neural network.

Study Type

Observational

Enrollment (Estimated)

200

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

  • Ukraine
      • Odessa, Ukraine, 65061
        • Recruiting
        • The Filatov Institute of Eye Diseases and Tissue Therapy

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

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Documented diagnosis of diabetes mellitus by definition.
  2. Understanding of the Study and willingness and ability to sign informed consent
  3. Patient age 18 or above
  4. Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes

Exclusion Criteria:

-1. 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.

4. 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
main group
have diabetes mellitus
Device: taking fundus photos using non-mydriatic fundus camera
using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.
control group
have risk factors for developing diabetes mellitus
Device: taking fundus photos using non-mydriatic fundus camera
using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy
Time Frame: Baseline
The accuracy of detecting of DR
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percent of invalid images
Time Frame: Baseline
The percent of invalid images for analysing by neural network
Baseline
The percent of false positive detection of DR
Time Frame: Baseline
The percent of false positive detection of DR in individuals without DR
Baseline

Collaborators and Investigators

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

Sponsor

The Filatov Institute of Eye Diseases and Tissue Therapy

Collaborators

CheckEye LLC
Oftacentro

Investigators

  • Principal Investigator: Andrii MD Korol, PhD, The Filatov Institute of Eye Diseases and Tissue Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

November 2, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02.10.2024

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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