RecruitingNot ApplicableNCT05463289

ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care


Sponsor

Johns Hopkins University

Enrollment

500 participants

Start Date

Jul 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine if use of a nonmydriatic fundus camera using autonomous artificial intelligence software at the point of care increases the proportion of underserved youth with diabetes screened for diabetic retinopathy, and to determine the diagnostic accuracy of the autonomous AI system in detecting diabetic retinopathy from retinal images of youth with diabetes.


Eligibility

Min Age: 8 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an AI-powered eye camera system designed to detect diabetic retinopathy — a complication of diabetes that damages the blood vessels in the back of the eye and can eventually cause vision loss — in children and teenagers with diabetes. The goal is to see whether this automated system is as accurate as traditional specialist eye exams, potentially making screening faster and more accessible. **You may be eligible if...** - You are a child or teen with Type 1 diabetes diagnosed for at least 3 years, and are age 11 or older (or in puberty) - OR you have Type 2 diabetes (any age) - OR you are 8–21 years old with known diabetic eye changes (enriched comparison group) **You may NOT be eligible if...** - You have other eye conditions that would make fundus photography difficult - You are unable to cooperate with the eye imaging process - You have a condition that prevents you from safely completing the exam Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTPoint of Care Autonomous AI diabetic retinopathy exam

Participants will undergo point-of-care diabetic retinopathy screening using autonomous artificial intelligence software to interpret retinal images taken with a non-mydriatic fundus camera and providing an immediate result.


Locations(1)

Johns Hopkins Pediatric Diabetes Center

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05463289


Related Trials