ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05463289
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Point of Care Autonomous AI diabetic retinopathy exam — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Jul 11, 2022
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Other: Diabetic Retinopathy Exam at the point of care
    Participants will undergo 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.

Primary Outcome Measure

Proportion screened for diabetic retinopathy [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Pediatric Diabetes CenterBaltimoreMaryland21287
Risa M Wolf, MD
[email protected]
410-955-6463

Find similar trials in Baltimore, MD

By condition
Type 1 diabetesType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Johns Hopkins Pediatric Diabetes Center· Baltimore, MD

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