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ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

RECRUITINGN/ASponsored by Johns Hopkins University
Actively Recruiting
PhaseN/A
SponsorJohns Hopkins University
Started2022-07-11
Est. completion2026-03-30
Eligibility
Age8 Years – 21 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05463289

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.

Eligibility

Age: 8 Years – 21 YearsHealthy volunteers accepted
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

Conditions4

Cystic Fibrosis-related DiabetesDiabetesType 1 DiabetesType 2 Diabetes

Locations1 site

Johns Hopkins Pediatric Diabetes Center
Baltimore, Maryland, 21287
Risa M Wolf, MD410-955-6463rwolf@jhu.edu

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