Multicenter Diagnostic Clinical Performance Study For Automated Detection of Diabetic Retinopathy

NCT05471986 | Unknown FDA Device

• 1 other identifier: EC-2023DR
• Study Type: observational
• Target: 900
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Retinopathy

Keywords

Diabetic Retinopathy; Artificial Intelligence; Deep Learning; Retinal images; Diabetic Macular Edema; Diabetic Eye Problems

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Positive Predictive Value

  1 visit (1 day)

• Negative Predictive Value

  1 visit (1 day)

Interventions

Color Fundus Photography/Non-Mydriatic Opthalmic Cameras DEVICE

Subjects will have underwent Fundus Photography using FDA approved non-mydriatic fundus cameras compatible with EyeCheckup which are either TOPCON NW400, CANNON CR2, CANNON CR2 Plus or OPTOMED AURORA IQ

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic Patients of 22 years or older

You may qualify if:

• A diagnosis of either diabetes type 1 or diabetes type 2
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ural Telekomunikasyon Sanayi Ticaret Anonim Sirketi: lead

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Rim Khazhin

  Ural Telekom

  STUDY CHAIR

Central Study Contacts

Rim Khazhin

CONTACT

+905357666383; trials@eye-checkup.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 25, 2022
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share