ACCESS: AI for pediatriC diabetiC Eye examS Study (ACCESS)

October 9, 2023 updated by: Johns Hopkins University

Autonomous AI for Diabetic Retinopathy Screening in Youth (AI-DR): A Randomized Control Trial

The purpose of this study is to determine if providing in clinic point-of-care autonomous AI diabetic retinopathy exams improves screening rates compared to standard of care referral to an eye care provider, in a randomized control trial in a racially and ethnically diverse cohort of youth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will recruit 164 individuals ages 8-21 with type 1 and type 2 diabetes. Participants will be randomized to usual care (referral to an eye care provider for a dilated eye exam) or the intervention arm and undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants in the intervention group 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. Participants in the standard of care group will have 6 months to complete the diabetic eye exam.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Pediatric Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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:

  • Diabetic eye exam within the last 6 months
  • Known diabetic retinopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care with educational reinforcement
Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement
Experimental: Diabetic Retinopathy Exam
Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera
Diagnostic test: Point of Care Autonomous AI diabetic retinopathy exam
Participants will get 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.
Other Names:
  • IDx-DR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Get Screened With a Diabetic Eye Exam
Time Frame: 6 months
The number of participants who get screened with a diabetic eye exam will be assessed for the AI group and the standard of care group referral to an eye care provider (ECP).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up Rates With an Eye Care Provider
Time Frame: 6 months
The number of patients that follow-up with an eye care provider (ECP), for participants in the standard of care group referred to ECP, and for participants in the AI group with an abnormal exam result that are then referred to the ECP for a dilated eye exam.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Eye Institute (NEI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2021

Primary Completion (Actual)

December 6, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 11, 2021

First Submitted That Met QC Criteria

November 11, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00288043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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