Multicenter Diagnostic Clinical Performance Study For Automated Detection of Diabetic Retinopathy

This study is a retrospective study to assess the efficacy and accuracy of the EyeCheckup software in screening for diabetic retinopathy in healthcare settings.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Device: Color Fundus Photography/Non-Mydriatic Opthalmic Cameras

Detailed Description

This is a clinical diagnostic performance study for EyeCheckup with data obtained consecutively at multiple geographically different sites within the US population. These sites include all healthcare settings with a trained ophthalmic camera operator using non-mydriatic cameras that are compatible with EyeCheckup. Moreover, primary endpoints are devised that will be used to validate EyeCheckup to diagnose DR in the primary care and eye care settings. During this color fundus images representing either 4 wide field or 7 standard fields of view will be graded by a qualified professional for diabetic retinopathy according to ETDRS on DRSS scale. The human grading output will be compared with diagnosis generated for diabetic retinopathy by AI software. A comparison of both these grades will be used to determine sensitivity and specificity for the EyeCheckup software for screening for diabetic retinopathy.

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Rim Khazhin; Phone Number: +905357666383; Email: trials@eye-checkup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Diabetic Patients of 22 years or older

Description

Inclusion Criteria:

• A diagnosis of either diabetes type 1 or diabetes type 2
• 22 years of age or older
• Patients Fundus images must include at least 1 macula centered and 1 optic disc nerve centered image
• All the subjects must be sequentially photographed meaning no omissions of data between a certain time frame by the sites providing images to ensure consecutive selection
• No history of any other retinal vascular disease, glaucoma, or another disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed)

Subject with image taken by color fundus photography that meets the following requirements:

• The resolution of image is 1024×1024 pixels or higher
• The ability to provide a 7 standard or 4 wide field of view
• Must obtained from either Topcon NW400 or Cannon Model CR-2 AF or CR-2 Plus AF or Optomed Aurora Cameras along with the following data: their age, ethnicity and gender, patient ocular history as evaluated of verified by the clinical sites where data is obtained

Exclusion Criteria:

• No diagnosis of either diabetes type 1 or diabetes type 2
• The macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the certified ophthalmologist who is grading the images.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and Specificity of EyeCheckup to detect more than mild diabetic retinopathy	1 visit (1 day)
Sensitivity and Specificity of EyeCheckup to detect vision-threatening diabetic retinopathy	1 visit (1 day)

Secondary Outcome Measures

Outcome Measure	Time Frame
Positive Predictive Value	1 visit (1 day)
Negative Predictive Value	1 visit (1 day)

Collaborators and Investigators

• Sponsor: URAL Telekomunikasyon San. Trade Inc.
• Investigators: Study Chair: Rim Khazhin, Ural Telekom

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Diabetic Macular Edema; Deep Learning; Diabetic Retinopathy; Diabetic Eye Problems; Retinal images
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: EC-2023DR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No