Recruiting

ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

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.

ClinicalTrials.gov IDNCT05463289

PhaseNA

Enrollment500

SponsorJohns Hopkins University

Age8 Years

SexALL

I'm interested View official listing

Conditions studied

Type 1 Diabetes, Type 2 Diabetes, Cystic Fibrosis-related Diabetes

About this study

Interventions

Diagnostic Test: Point 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.

Primary outcomes

Proportion screened for diabetic retinopathy (Day 1)

Eligibility information

Inclusion Criteria: Meets American Diabetes Association (ADA) criteria for diabetic retinopathy screening: * Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty * Diagnosis of Type 2 diabetes Enriched cohort: * Patients with Type 1 or Type 2 diabetes, * 8-21 years of age with known diabetic retinopathy (true positives). * No time limit on last diabetic eye exam. Exclusion Criteria: * Known diabetic eye exam in the last 12 months

Study locations

Johns Hopkins Pediatric Diabetes Center, Baltimore, Maryland 21287 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.