Project Summary/Abstract: In the United States, diabetes (DM) impacts 37.3 million people (11.3% population) and 96 million people aged 18 years or older have prediabetes (38.0% of the adult US population). One in three of DM will develop diabetic retinopathy (DR) in their lifetime, which is the leading cause of blindness in adults leading to permanent disability. Ethnic minority groups are at greater risk for vision-threatening disease and disability from diabetes. Vision loss can be the result of progression to proliferative DR (PDR) or from diabetic macular edema (DME). An eye exam can detect these conditions and may include the technology of optical coherence tomography (OCT), fundus photography (FP), and/or fluorescein angiography (FA). OCT measures central macular thickness (CMT) to detect DME and can be used to guide treatment decisions, while FP and FA improve PDR detection. Subjects in many DR clinical trials are disproportionately White and male compared to the population undergoing DR treatment. Early evidence suggests that minoritized men with greater CMT are at risk for vision loss if left untreated. Given that DM and DR are more prevalent in minorities and that 90% of DM-related vision loss is preventable, immediate effort is needed to address this disparity and evaluate predictive capabilities of DR stage, CMT, clinical measures (hemoglobin A1c, blood pressure, etc.), and social determinants of health (SDH) to improve screening and treatment guidelines for high-risk groups. The proposed study, Health Equity and Access to Leverage Technology for Improved DR Outcomes (HEAL-DR) fulfills a large gap in the current NIH ocular health disparities portfolio with modelling (OCT machine data) to better identify minority people at greatest risk for both undetected and high-risk disease using the Sight OUtcomes Research CollaborativE (SOURCE). SOURCE links electronic health record data from 35 large academic medical centers to capture visual exam data and details typically found in clinical trials. SOURCE overcomes major data barriers in ophthalmology health disparities work because it contains robust, granular eye exam data for assessing treatment, quality, and outcomes, combined with key information on race and ethnicity, gender, SDH measures, medications, HbA1c, Centers for Disease Control National Death Index Data and others. Outputs from this research will enhance visual risk assessment with new modelling to better identify minority people at greatest risk for vision loss from undetected and/or worsening disease (early PDR, occult DME) on a population level. This study fulfills the target goals for National Eye Institute and Healthy People 2030 and will lead to enhanced clinical guidelines for targeted outreach to those at greatest risk of DM related visual impairment. This study: 1) is innovative, 2) is stakeholder-driven by both the American Medical Association (AMA), Center for Health Equity and the American Academy of Ophthalmology (AAO), Task Force on Eye Care Disparities), 3) uses SOURCE data from multiple states and regions to analyze and reduce health care disparities in DR. The project is aligned with the missions of the NIH, AMA, AAO, and the National Academy of Medicine (NAM) on reducing health disparities and the prevention of vision loss.

Project Narrative: Subjects in diabetic macular edema (DME) clinical trials in the United States are disproportionately White and male, compared with the population undergoing treatment for DME and limited evidence suggests that minoritized men with greater central macular thickness (CMT) are at risk for vision loss if left untreated. The Health Equity and Access to Leverage Technology for Improved DR Outcomes (HEAL-DR) study seeks to understand the association of optical coherence tomography and CMT, laboratory, and clinical measures for racial and ethnic minority patients for reducing visual impairment using an innovative strategy that incorporates data from the Sight OUtcomes Research CollaborativE (SOURCE). This research will have high impact by providing the health sector and other stakeholders research that will enhance visual risk assessment to better identify minority people at greatest risk for vision loss from undetected and/or worsening disease on a population level to enhance clinical guidelines for high-risk minority populations.