Development, Validation, and Innovation in Ophthalmic Laser-Based Imaging: Report From a US Food and Drug Administration-Cosponsored Forum.

In April 2019, the US Food and Drug Administration, in conjunction with 11 professional ophthalmic, vision science, and optometric societies, convened a forum on laser-based imaging. The forum brought together the Food and Drug Administration, clinicians, researchers, industry members, and other stakeholders to stimulate innovation and ensure that patients in the US are the first in the world to have access to high-quality, safe, and effective medical devices. This conference focused on the technology, clinical applications, regulatory issues, and reimbursement issues surrounding innovative ocular imaging modalities. Furthermore, the emerging role of artificial intelligence in ophthalmic imaging was reviewed. This article summarizes the presentations, discussion, and future directions.

Alzheimer's team care approach-akin to diabetes-in the development, validation, and population assessment of retinal biomarkers for disease.

There exists a public health imperative to discover and to develop disease-modifying Alzheimer's disease (AD) therapeutics to protect the health of millions of individuals facing AD. Achievement of this goal will be dependent on developing the clinical tools to detect high risk, in the earliest phases of the disease, and at the population level. This article describes the study of retinal biomarkers for the identification of, and tracking of change over time for, individuals in the preclinical stage of AD and substantiates the need for a major cross-disciplinary effort for comparison across labs and clinical sites using diabetes risk monitoring as a perfect analogy. Proposed framework would: (1) support AD working groups across disciplines; (2) establish common imaging platforms to develop and test basic standards, and minimum datasets to embrace and test novel innovations as they emerge; and (3) accelerate AD prevention and quality improvement in real-world care.

Retinal imaging in Alzheimer's and neurodegenerative diseases.

In the last 20 years, research focused on developing retinal imaging as a source of potential biomarkers for Alzheimer's disease and other neurodegenerative diseases, has increased significantly. The Alzheimer's Association and the Alzheimer's & Dementia: Diagnosis, Assessment, Disease Monitoring editorial team (companion journal to Alzheimer's & Dementia) convened an interdisciplinary discussion in 2019 to identify a path to expedite the development of retinal biomarkers capable of identifying biological changes associated with AD, and for tracking progression of disease severity over time. As different retinal imaging modalities provide different types of structural and/or functional information, the discussion reflected on these modalities and their respective strengths and weaknesses. Discussion further focused on the importance of defining the context of use to help guide the development of retinal biomarkers. Moving from research to context of use, and ultimately to clinical evaluation, this article outlines ongoing retinal imaging research today in Alzheimer's and other brain diseases, including a discussion of future directions for this area of study.

Measuring access to eye care: a public health perspective.

PURPOSE: To examine the different dimensions of access to eye care from a public health perspective. METHODS: We substantively review the theoretical and empirical literature on access to eye care and summarize the major considerations in measuring access to eye care using a modified behavioral framework. RESULTS: We found that progress has been made, but some gaps still remain in measuring access to eye care. Most studies have focused on individual characteristics and use of eye care services. Only a very few studies have touched on contextual characteristics, such as demographic make-up of the area in which the patient lives, and their impact on the use of eye care services. Few studies have explored the linkage between the use of eye care services and outcomes or between the use of such services and patient satisfaction. CONCLUSIONS: To address a variety of demands from patients, providers, and policy makers, it is necessary to account for potential access and realized access measures. We need to adopt new methods in assessing the relationship between contextual characteristics and use of eye care services. Moreover, we need to better understand patients' satisfaction and their relationship with utilization and health outcomes.

Diabetes mellitus and visual impairment: national health and nutrition examination survey, 1999-2004.

OBJECTIVE: To examine the prevalence and correlates of visual impairment (VI) among US adults with and without diabetes mellitus. METHODS: Using National Health and Nutrition Examination Surveys conducted during 1999-2004, we estimated the prevalence of presenting (correctable or uncorrectable), correctable, and uncorrectable VI among Americans 20 years or older with and without diabetes. Data were weighted to make estimates representative of the US civilian noninstitutionalized population. We used multivariate logistic regression to calculate odds ratios and corresponding 95% confidence intervals. RESULTS: Approximately 11.0% of US adults with diabetes had some form of VI (3.8% uncorrectable and 7.2% correctable). Among those without diabetes, 5.9% had some form of VI (1.4% uncorrectable and 4.5% correctable). People with diabetes were more likely to have uncorrectable VI than those without diabetes, even after controlling for selected other factors (P < .05). Our findings also suggest a strong association between VI (correctable and uncorrectable) and older age, member of racial/ethnic minorities, lower income, and lack of health insurance, all independent of diabetes status (P < .05). CONCLUSIONS: Vision loss is more common in people with diabetes than in people without diabetes. Diverse public health strategies are needed to reduce the burden of both correctable and uncorrectable VI.

Eye care in the United States: do we deliver to high-risk people who can benefit most from it?

OBJECTIVE: To estimate the levels of self-reported access of eye care services in the nation. METHODS: We analyzed data from the 2002 National Health Interview Survey (30 920 adults aged > or =18 years). We estimated the number of US adults at high risk for serious vision loss and assessed factors associated with the use of eye care services. RESULTS: An estimated 61 million adults in the United States were at high risk for serious vision loss (they had diabetes, had vision or eye problems, or were aged > or =65 years); 42.0% of the 78 million adults who had dilated eye examinations in the past 12 months were among this group. Among the high-risk population, the probability of having a dilated eye examination increased with age, education, and income (P<.01). The probability of receiving an examination was higher for the insured, women, persons with diabetes, and those with vision or eye problems (P<.01). Approximately 5 million high-risk adults could not afford eyeglasses when needed; being female, having low income, not having insurance, and having vision or eye problems were each associated with such inability (P<.01). CONCLUSIONS: There is substantial inequity in access to eye care in the United States. Better targeting of resources and efforts toward people at high risk may help reduce these disparities.