ACCESS 2: AI for pediatric diabetic eye exams

This study, ACCESS 2, is looking at whether using a special camera with artificial intelligence (AI) can help more young people with diabetes get screened for diabetic retinopathy (a common eye problem caused by diabetes). The study will use a "Point of Care Autonomous AI diabetic retinopathy exam" where a camera takes pictures of your retina (the back of your eye) and AI software immediately tells you the results. We want to see if this method increases the number of underserved youth who get screened and how accurate the AI system is at finding diabetic retinopathy. You might be able to join if you are 8 to 21 years old and have Type 1 or Type 2 diabetes. The study aims to enroll up to 500 participants.

Study design
This is an interventional study planning to enroll up to 500 participants. It will assess the use of autonomous AI for diabetic retinopathy screening.
What's involved
You will undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. You will receive immediate results from the AI system.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, screening for diabetic retinopathy, is measured at Day 1. Follow-up beyond this is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05463289

ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

Recruiting
NAAges 8–21InterventionalScreening
Johns Hopkins University
~500 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Point of Care Autonomous AI diabetic retinopathy exam

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion screened for diabetic retinopathy
Measured over Day 1
Type 1 Diabetes
Type 2 Diabetes
Cystic Fibrosis-related Diabetes
1 sites across 1 states
Maryland1
  • Risa M Wolf, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

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Eligibility criteria

Inclusion

Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty
Diagnosis of Type 2 diabetes
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

Known diabetic eye exam in the last 12 months
  • Proportion screened for diabetic retinopathyDay 1

    Equivalence in proportion screened for diabetic retinopathy of white and non-white youth with autonomous AI