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NCT05131451 Clinical Trial

ACCESS: AI for pediatriC diabetiC Eye examS Study

Type 2 Diabetes Clinical Trial

— ACCESS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05131451
Other study ID # IRB00288043
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 24, 2021
Est. completion date December 31, 2022

Study information
Verified date October 2023
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 164
Est. completion date December 31, 2022
Est. primary completion date December 6, 2022
Accepts healthy volunteers No
Gender All
Age group 8 Years to 21 Years
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: - Diabetic eye exam within the last 6 months - Known diabetic retinopathy

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Johns Hopkins Pediatric Diabetes Center Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
Johns Hopkins University National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Who Get Screened With a Diabetic Eye Exam 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 Follow-up Rates With an Eye Care Provider 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
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