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ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

Recruiting
8-21 years
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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.

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.

Eligibility

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 Criteria:

  • Known diabetic eye exam in the last 12 months

Study details
    Type 1 Diabetes
    Type 2 Diabetes
    Cystic Fibrosis-related Diabetes

NCT05463289

Johns Hopkins University

24 June 2024

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