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ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

NCT05463289 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Risa M Wolf, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05463289 on ClinicalTrials.gov