ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

Last updated: May 27, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetes Prevention

Cystic Fibrosis

Treatment

Point of Care Autonomous AI diabetic retinopathy exam

Clinical Study ID

NCT05463289
IRB00180692
1R01EY033233-01
  • Ages 8-21
  • All Genders

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.

Eligibility Criteria

Inclusion

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

Exclusion

Exclusion Criteria:

  • Known diabetic eye exam in the last 12 months

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Point of Care Autonomous AI diabetic retinopathy exam
Phase:
Study Start date:
July 11, 2022
Estimated Completion Date:
August 29, 2025

Study Description

This study will recruit 500 individuals ages 8-21 with type 1 and type 2 diabetes. Participants will undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants will receive the diabetic eye exam results immediately from the autonomous AI system, and if abnormal will be referred to an eye care provider for a dilated eye exam. The autonomous AI interpretation will also be compared to consensus grading of retinal specialists to determine if there is agreement.

Connect with a study center

  • Johns Hopkins Pediatric Diabetes Center

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

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