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ACCESS: AI for pediatriC diabetiC Eye examS Study

NCT05131451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2023-11-02

Study results available
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Summary

The purpose of this study is to determine if providing in clinic point-of-care autonomous AI diabetic retinopathy exams improves screening rates compared to standard of care referral to an eye care provider, in a randomized control trial in a racially and ethnically diverse cohort of youth.

Conditions

Interventions

DIAGNOSTIC_TEST

Point of Care Autonomous AI diabetic retinopathy exam

Participants will get a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.

Sponsors & Collaborators

Principal Investigators

  • Risa Wolf, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2022-12-06
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT05131451 on ClinicalTrials.gov