ACTIVE_NOT_RECRUITING

Diabetic Retinopathy Screening Point-of-Care Artificial Intelligence

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study is being conducted to improve eye care by using artificial intelligence (AI) to make diabetic eye screenings faster and more accessible. AI technology mimics human decision-making, enabling computers and systems to analyze medication information. Specifically for this screening, AI examines digital images of the eye and based on that information, may identify if a participant has diabetic retinopathy. It can assist doctors in making decisions about a participant's diagnosis, treatment or care plans to improve patient care. This is a collaboration between San Ysidro Health (SYHealth), University of California, San Diego (UC San Diego), and Eyenuk. The Kaiser Permanente Augmented Intelligence in Medicine and Healthcare Initiative (AIM-HI) awarded SYHealth funds to demonstrate the value of AI technologies in diverse, real-world settings.

Official Title

Diabetic Retinopathy Screening Point-of-Care Artificial Intelligence -DRES-POCAI: AI - Clinical Intervention at San Ysidro Health

Quick Facts

Study Start:2024-07-27
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06721351

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.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Capacity to provide informed consent. Individuals must have the capacity to understand the study information, risks, and benefits and voluntarily provide informed consent.
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. 3. Established and active patient of SYHealth-CV and KC (having a medical appointment in the last 18 months).
  4. 4. Person aged 22 and older.
  5. 5. Established diagnosis of DM.
  6. 6. Medical appointment(s) (in-person or telehealth) scheduled during the intervention period.
  7. 7. Has not completed a dilated eye exam or retinal exam in the last 11months.
  1. 1. have a prior diagnosis of DR, macular edema, or retinal vascular occlusion;
  2. 2. have persistent visual Impairment in one or both eyes;
  3. 3. history of ocular injections, laser treatment of the retina, or intraocular surgery (excluding cataract surgery);
  4. 4. pregnant women; and
  5. 5. diagnosis of mental or degenerative disease that prevents self-consent for the study.

Contacts and Locations

Principal Investigator

Fatima Muñoz, MD, MPH
PRINCIPAL_INVESTIGATOR
San Ysidro Health
Nicole Stadnick, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

San Ysidro Health Chula Vista
Chula Vista, California, 91910
United States
San Ysidro Health - Comprehensive Health Center - Ocean View
San Diego, California, 92113
United States
San Ysidro Health King-Chavez Health Center
San Diego, California, 92114
United States

Collaborators and Investigators

Sponsor: Centro De Salud La Comunidad De San Ysidro Inc DBA: San Ysidro Health

  • Fatima Muñoz, MD, MPH, PRINCIPAL_INVESTIGATOR, San Ysidro Health
  • Nicole Stadnick, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

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 Registration Dates

Study Start Date2024-07-27
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2024-07-27
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • Point-of-care (POC) artificial intelligence (AI) technology for DR screening
  • Diabetic Retinopathy (DR) Screening
  • Diabetes

Additional Relevant MeSH Terms

  • Diabetic Retinopathy (DR)