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Search / Trial NCT06721351

Diabetic Retinopathy Screening Point-of-Care Artificial Intelligence

Launched by CENTRO DE SALUD LA COMUNIDAD DE SAN YSIDRO INC DBA: SAN YSIDRO HEALTH · Dec 5, 2024

Trial Information

Current as of July 06, 2025

Enrolling by invitation

Keywords

Point Of Care (Poc) Artificial Intelligence (Ai) Technology For Dr Screening Diabetic Retinopathy (Dr) Screening Diabetes

ClinConnect Summary

This clinical trial is exploring how artificial intelligence (AI) can help improve eye care for people with diabetes, specifically by making screenings for diabetic retinopathy (DR) quicker and easier. Diabetic retinopathy is a condition that can affect the eyes of individuals with diabetes, and early detection is important for effective treatment. In this study, AI will analyze digital images of the eye to help doctors determine if a participant has DR, which may lead to better diagnosis and treatment options. The trial is being conducted by San Ysidro Health, UC San Diego, and Eyenuk, with funding from Kaiser Permanente to test AI technology in real-world settings.

To participate, individuals must be at least 22 years old, have a current diagnosis of diabetes, and have not had a detailed eye exam in the past 11 months. They should also be patients of San Ysidro Health and available for the study's duration. Participants can expect to undergo eye screenings that use AI technology, which may enhance their overall eye care experience. It’s important to note that individuals with certain eye conditions or treatments, as well as pregnant women and those unable to consent for themselves, will not be eligible for this study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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. Stated willingness to comply with all study procedures and availability for the duration of the study.
  • 3. Established and active patient of SYHealth-CV and KC (having a medical appointment in the last 18 months).
  • 4. Person aged 22 and older.
  • 5. Established diagnosis of DM.
  • 6. Medical appointment(s) (in-person or telehealth) scheduled during the intervention period.
  • 7. Has not completed a dilated eye exam or retinal exam in the last 11months.
  • Exclusion Criteria:
  • 1. have a prior diagnosis of DR, macular edema, or retinal vascular occlusion;
  • 2. have persistent visual Impairment in one or both eyes;
  • 3. history of ocular injections, laser treatment of the retina, or intraocular surgery (excluding cataract surgery);
  • 4. pregnant women; and
  • 5. diagnosis of mental or degenerative disease that prevents self-consent for the study.

About Centro De Salud La Comunidad De San Ysidro Inc Dba: San Ysidro Health

Centro de Salud La Comunidad de San Ysidro Inc., doing business as San Ysidro Health, is a prominent healthcare organization dedicated to providing comprehensive, high-quality medical services to underserved communities in the San Ysidro region. With a commitment to promoting health equity, San Ysidro Health leverages its robust clinical infrastructure and a multidisciplinary team to conduct innovative clinical trials that advance medical research and improve patient outcomes. The organization prioritizes community engagement and aims to address health disparities through collaborative efforts, ensuring that diverse populations have access to cutting-edge treatments and therapies.

Locations

Chula Vista, California, United States

San Diego, California, United States

Patients applied

0 patients applied

Trial Officials

Fatima Muñoz, MD, MPH

Principal Investigator

San Ysidro Health

Nicole Stadnick, PhD

Principal Investigator

University of California, San Diego

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported