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ACCESS2: ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05463289
Collaborator
National Eye Institute (NEI) (NIH)
500
Enrollment
1
Location
1
Arm
22.1
Anticipated Duration (Months)
22.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
All participants will undergo point-of-care diabetic retinopathy screening. Participants will know that they will undergo point-of-care diabetic retinopathy screening at the time of consenting.
Primary Purpose:
Screening
Official Title:
Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care
Actual Study Start Date :
Jul 11, 2022
Anticipated Primary Completion Date :
May 15, 2024
Anticipated Study Completion Date :
May 15, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam
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.
Other Names:
  • IDx-DR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion screened for diabetic retinopathy [2 years]

      Equivalence in proportion screened for diabetic retinopathy of white and non-white youth with autonomous AI

    Secondary Outcome Measures

    1. Percentage of agreement in interpretation of retinal images [2 years]

      Agreement in interpretation of retinal images between autonomous AI and consensus grading by ophthalmologists

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Pediatric Diabetes Center Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Johns Hopkins University
    • National Eye Institute (NEI)

    Investigators

    • Principal Investigator: Risa M Wolf, MD, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT05463289
    Other Study ID Numbers:
    • IRB00180692
    • 1R01EY033233-01
    First Posted:
    Jul 18, 2022
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Johns Hopkins University
    Diabetic Retinopathy
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Diabetes Mellitus

    Study Results

    No Results Posted as of Jul 18, 2022