NCT06112691

ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY IN THE CHERNIVTSI REGION (Pilot Study)

USING ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 660 (estimated)
• Sponsor: The Filatov Institute of Eye Diseases and Tissue Therapy · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.

Detailed description

The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions. This study is planned as a follow-up. Participants who meet the eligibility criteria will be recruited from sites staffed by the trained photographers. After assessing eligibility and securing written informed consent, fundus photographs will be captured using a nonmydriatic ocular fundus camera. Images will be taken according to a specific RAssbyAI Check Eye's imaging protocol provided to camera operator, and then analyzed by the RAssbyAI Check Eye's. The photography protocol consists of two images of the ocular fundus (one optic disc centered, one fovea centered).

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DEVICE	taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock	using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.

Timeline

• Start date: 2022-02-01
• Primary completion: 2024-10-01
• Completion: 2024-11-01
• First posted: 2023-11-01
• Last updated: 2023-11-01

Locations

1 site across 1 country: Ukraine