Actively Recruiting

Phase Not Applicable
Age: 8Years - 21Years
All Genders
NCT05463289

ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

Led by Johns Hopkins University · Updated on 2026-03-27

500

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Eye Institute (NEI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

Who Can Participate

Age: 8Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meets American Diabetes Association criteria for diabetic retinopathy screening
  • Diagnosis of Type 1 diabetes for 3 or more years and age 11 or in puberty
  • Diagnosis of Type 2 diabetes
  • Patients aged 8 to 21 years with known diabetic retinopathy (true positives) in the enriched cohort
  • No time limit on last diabetic eye exam for the enriched cohort
Not Eligible

You will not qualify if you...

  • Known diabetic eye exam in the last 12 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Johns Hopkins Pediatric Diabetes Center

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

R

Risa M Wolf, MD

CONTACT

A

Alvin Liu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2 | DecenTrialz