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OpenTrials
Completed

NCT Number: NCT05131451

ACCESS: AI for pediatriC diabetiC Eye examS Study

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Type 2 Diabetes Vascular Diseases

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Pediatric Diabetes Center

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point of Care Autonomous AI diabetic retinopathy exam

Diagnostic Test

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Acronym: ACCESS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2021
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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