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<span>NAEC Meeting Minutes - June 16, 2023</span>
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<p><strong>National Institutes of Health</strong></p><p><strong>National Eye Institute</strong><br><strong>Minutes of the National Advisory Eye Council</strong><br><strong>One Hundred Sixty-Fifth Meeting</strong><br><strong>June 16, 2023</strong></p><ul><li><a href="https://videocast.nih.gov/watch=49720"><strong>Videocast</strong></a></li></ul><p>The National Advisory Eye Council (NAEC) convened for its 165th meeting at 9:00 a.m. on Friday, June 16, 2023. The hybrid meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended either virtually or in-person. Michael F. Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen C. Anderson, PhD, served as the Executive Secretary. The meeting was open to the public from 9:00 a.m. until 2:30 p.m. The meeting was closed to the public from 2:45 p.m. until 5:00 p.m. for the review of grant and cooperative agreement applications.</p><h2>Council Members Present:</h2><p>Dr. Michael F. Chiang, Chair (in-person)<br>Dr. Kathleen Anderson, Executive Secretary (in-person)<br>Dr. Terete Borrás (in-person)<br>Dr. James Coughlan (in-person)<br>Dr. Reza Dana (virtual)<br>Dr. Thomas Gardner (in-person)<br>Dr. Maria B. Grant (in-person)<br>Dr. Renu Kowluru (in-person)<br>Dr. Maureen Maguire (in-person)<br>Dr. Donald Mutti (in-person)<br>Dr. Pradeep Ramulu (in-person</p><h3>NIH Staff Members Present:</h3><p>Dr. Neeraj Agarwal (in-person)<br>Lisa Applewhite (in-person)<br>Dr. Houmam Araj (virtual)<br>Chelsea Bender (virtual)<br>Dr. Sangeeta Bhargava (in-person)<br>Nathan Brown (in-person)<br>Dr. Rachel Caspi (virtual)<br>Dr. Emily Chew (virtual)<br>Karen Colbert (virtual)<br>Dr. Ximena Corso-Diaz (virtual)<br>Dr. Mary Frances Cotch (virtual)<br>Kathryn DeMott (virtual)<br>Donald Everett (in-person)<br>Dr. Edmond Fitzgibbon (virtual)<br>Dr. Martha Flanders (virtual)<br>Dr. Ashley Fortress (virtual)<br>Ellaine Galindez-Balut (virtual)<br>Dr. James Gao (virtual)<br>Alexandra Gavrilovic (virtual)<br>Dr. Shefa Gordon (in-person)<br>Dr. Tony Gover (in-person)<br>Dustin Hays (in-person)<br>Lateefah Hill (in-person)<br>Dr. Brian Hoshaw (in-person)<br>Dr. Koray Dogan Kaya (virtual)<br>Stephanie Kennedy (virtual)<br>Dr. Alicia Kerr (virtual)<br>Dr. Jimmy Le (in-person)<br>Dr. Paek Lee (in-person)<br>Dr. Huirong Li (virtual)<br>Dr. Ellen Liberman (in-person)<br>Renee Livshin (virtual)<br>Nikitha Maan (virtual)<br>Dr. George McKie (in-person)<br>Dr. Sheldon Miller (virtual)<br>Erika Nelson (virtual)<br>Dr. Lisa Neuhold (in-person)<br>William “Russ” O’Donnell (virtual)<br>Michael Phan (in-person)<br>Dr. Mary Ann Redford (virtual)<br>Dr. Michael Redmond (virtual)<br>Melissa Reeves (virtual)<br>Carissa Reilly-Weedon (virtual)<br>Dr. David Schneeweis (in-person)<br>Dr. Jennifer Schiltz (in-person)<br>Dr. Grace Shen (in-person)<br>Karen Robinson Smith (virtual)<br>Dr. Hongman Song (virtual)<br>Dr. Afia Sultana (virtual)<br>Dr. Santa Tumminia (in-person)<br>Dr. Cheri Wiggs (in-person)<br>Dr. Biying Xu (virtual)<br>Dr. Cheng-Rong Wu (virtual)<br>Maria Zacharias (in-person)</p><h3><strong>Others Present Virtually:</strong></h3><p>Dr. Monica Hooper (virtual), Guest Speaker<br>Dr. Stephen McLeod (virtual), Guest Speaker<br>Television Operations</p><p>NOTE: Due to the open videocast format of this meeting, additional NIH staff and members of the public were able to observe the open session of the meeting live and after it had been archived.</p><h2>WELCOME AND INTRODUCTIONS</h2><p><strong>—Dr. Michael Chiang, Chair, NAEC, and Director, NEI</strong></p><p>Dr. Chiang called the 165th NAEC meeting to order. He welcomed new council members, Drs. Maria B. Grant, Donald O. Mutti, and Pradeep Ramulu, to the meeting. Dr. Grant is an ophthalmologist studying the use of stem cells for vascular repair in retinal diseases at the University of Alabama at Birmingham. Dr. Mutti is an optometrist at Ohio State University investigating myopia. Dr. Ramulu is a glaucoma specialist and ophthalmologist at Johns Hopkins University. All Council members briefly introduced themselves and Dr. Chiang thanked the organizers for enduring the challenges of setting it up as a hybrid event.</p><h2>COUNCIL PROCEDURES AND RELATED MATTERS</h2><p><strong>—Dr. Kathleen Anderson, Executive Secretary, NAEC, and Director, Division of Extramural Activities (DEA)</strong></p><p>Dr. Anderson welcomed NEI staff, members of the public who were in attendance virtually and in person, Center for Scientific Review staff, and staff members who organized and provided technical support. She also made some logistical announcements regarding participation in a hybrid meeting.</p><p>She noted that future NAEC meetings are listed on the open agenda and on the <a href="https://www.nei.nih.gov/about/advisory-committees/national-advisory-eye-council-naec/national-advisory-eye-council-naec-meetings">NEI website</a>. The next in-person NAEC meeting will be held on Friday, October 13, 2023. In addition, she noted that there were applications submitted to late funding announcements issued by other NIH institutes that needed to be considered for funding before the end of the fiscal year. Those applications will be made available for evaluation by council members via the electronic council book (ECB) in August.</p><p>Minutes of the October 2022 NAEC meeting were made available in the Electronic Council Book (ECB) prior to the meeting. A motion to accept the October meeting was made, seconded, and approved unanimously.</p><p>Each year in January, the Committee is asked to review the NEI Advisory Council Operating Procedures. The updated procedures were posted in the ECB for review and no substantive changes were made. A motion to accept the 2023 Operating Procedures was made, seconded, and approved unanimously.</p><h2>NEI DIRECTOR’S REPORT</h2><p><strong>NEI DIRECTOR’S REPORT</strong> —Dr. Michael F. Chiang<br>Dr. Chiang began by noting the value of social media in disseminating news about research, clinical care, and policy, as well as keeping the vision research community aware of funding opportunities. He asked committee members to consider following NEI’s social media accounts and to encourage their institutions to do the same.</p><p><strong>NIH and NEI Leadership Updates</strong>—In May, President Biden nominated Dr. Monica<br>Bertagnolli as the 17th Director of the National Institutes of Health. Dr. Bertagnolli currently serves as Director of the National Cancer Institute. She will take up the position of NIH Director pending Senate confirmation. Additionally, Kapil Bharti, PhD, has was hired as the new Scientific Director for NEI.</p><p><strong>NEI Updates</strong> –Dr. Chiang congratulated several NEI investigators who received major awards.</p><p>The 2023 Helen Keller Prize for Vision Research was awarded to six scientists who conducted research on the genetic basis of vision loss. This work ultimately led to the development of Luxterna, a gene therapy treatment for inherited retinal disease and the first FDA-approved gene therapy. The development began with research conducted in NEI’s Intramural Program cloning the RPE65 gene, which makes a protein required for vision.</p><p>Two NEI senior investigators will receive major awards at ARVO’s 2024 Annual Meeting.<br>Emily Chew will receive the Proctor Medal and Anand Swaroop will receive the Friedenwald Award. NEI staff scientist Dr. Ruchi Sharma will receive the Knights Templar Eye Foundation Award for her work on developing a technique for growing retinal pigment epithelium cells from stem cells.</p><p>Six NEI-funded scientists were elected to the National Academy of Sciences. They are Dr. David Brainard from the University of Pennsylvania who studies color constancy, Dr. Jennifer Elisseeff from Johns Hopkins who studies biosynthetic corneal implants, Dr. Marla Feller from the University of California, Berkley, who studies retinal development, Dr. Duojia Pan from the University of Texas Southwestern who studies retinal development, Dr. Michael Shadlen from Columbia University who studies visual perception, and Dr. Hongkui Zeng at the Allen Institute whose work addresses connectomics, open science, and big data in vision.</p><p><strong>Additional NEI Grantee Highlights</strong>—Dr. Chiang also highlighted the work of several other NEI-supported researchers. Dr. Maya Koronyo-Hamaoui at Cedars-Sinai studies retinal vascular tight junctions as a pathway for amyloid beta protein deposition in the retina and identified biomarkers indicating deficiencies in the blood-retinal barrier that may be useful for Alzheimer disease screening and monitoring. Krzysztof Palczewski at the University of California, Irvine, studies how stress perturbs cellular and tissue homeostasis and has identified a class of small molecules that can potentially treat stress-associated retinal diseases.</p><p><strong>Highlights of New Developments and Innovative Research</strong>—Dr. Chiang noted that driving innovative research is one pillar of NEI’s mission statement. He highlighted recent developments in several research projects.</p><p>One effort he described is a $97 million public-private partnership called the AMP Bespoke Gene Therapy Consortium, which aims to develop standards to speed the development of gene therapies for rare diseases. Recently the effort announced that eight diseases, three of which are eye-related, have been selected for gene therapy research and clinical trials. These diseases are NPHP5 retinal degeneration (led by Dr. Tomas Aleman at the University of Pennsylvania), congenital hereditary endothelial dystrophy (led by Dr. Anthony Aldave at the University of California, Los Angeles), and retinitis pigmentosa 45 (led by Dr. Stephen Tsang at Columbia University.). Dr. Chiang acknowledged NEI staff members Dr. Santa Tumminia, Dr. Hongman Song, Dr. Mary Ann Redford, and Dr. Wei Li for their work on this project.</p><p>Another innovative research effort is a project at the intersection of neuroscience and<br>regeneration, launched in 2014 as the NEI Audacious Goals Initiative (AGI). This $80 million project has developed tools for visualizing the eye and optic nerve at unprecedented detail and has focused on collaboration, team science, and data sharing. NEI is planning a symposium, AGI at Age 10, that aims to define next steps for translating research into new therapies. Additionally, two upcoming workshops are planned: a workshop on the role extracellular vesicles in vision on September 14, 2023, and a workshop on visual neuroplasticity on January 10, 2024. Both workshops will be held virtually. NEI staff members leading these workshops include Drs. Tom Greenwell, Ashely Fortress, Hongman Song, Martha Flanders, and. Alicia Kerr.</p><p><strong>Highlights of Collaborative Research</strong>—Dr. Chiang noted that another element of NEI’s<br>mission statement is fostering collaboration. He highlighted several collaborative projects in which NEI is involved.</p><p>One collaboration focuses on cortical visual impairment (CVI). Dr. Cheri Wiggs and Don Everett at NEI are working with colleagues at NICHD and NINDS as well as other stakeholders to organize a workshop on CVI co-chaired by Dr. Melinda Chang at the University of Southern California and Dr. Lofti Merabet at Harvard University. A key aim is to create a CVI registry to be hosted by NEI that will support research studies. Another collaborative project addresses myopia and aims to identify a research agenda to better understand its pathogenesis and rising incidence. The study committee, co-chaired by Dr. Kevin Fricks at Johns Hopkins University and Dr. Terri Young at the University of Wisconsin-Madison, will hold a public meeting on July 18, 2023.</p><p>Dr. Chiang also highlighted three collaborative data science projects. One of these is All of Us, a landmark project that aims to gather a vast trove of health data from 1 million people from diverse backgrounds over several years. Efforts to get more eye data, specifically Optical Coherence Tomography (OCT) imaging, into the data set are ongoing and include a recent workshop led by Dr. Kerry Goetz at NEI. Another collaborative data project is Bridge2AI, which aims to build data sets and which held its first annual in-person meeting on April 17, 2023. One of four funded components of the project is led by ophthalmologists Drs. Aaron Lee and Cecilia Lee at the University of Washington, with the help of NEI program officer Dr. James Gao. They will be launching a pilot study on salutogenesis and diabetes. A third data collaboration project is called AIM-AHEAD, which intends to use AI and machine learning to address health disparities by detecting bias in the medical record. Ophthalmic imaging data is easy to obtain, quick and objective, and could be used as a clear measure to help anchor observations that are subject to bias.</p><p>NEI has an active Notice of Special Interest (NOSI) on the Development of Innovative<br>Informatics & Data Science Technologies, Tools, and Methods for Vision Research. A NOSI<br>does not have set-aside funding but indicates an area of interest for the institute. Researchers can find NOSIs by searching for “current funding opportunities” on the NEI website or search for “Notice of Special Interest” in the NIH Guide. In responding to a NOSI, researchers should be<br>sure to enter the NOSI’s number into the Agency Routing Identifier field (box 4B) of the SF424 application form.</p><p>Dr. Chiang also called out a collaboration with the Department of Defense (DoD), which has a vision research program. NEI has worked with the DoD on this project since 2018. Dr. Tian Wang is the DoD program officer and Dr. Tony Gover is the NEI program officer for this<br>program. The DoD is particularly interested in eye injury or visual dysfunction related to military exposure. Over $ 4 million dollars of projects have been funded through this collaboration.<br>Applications are due by November 8, 2023.</p><p><strong>Educating Stakeholders about Visual Impairment</strong>—Dr. Chiang noted that another element of NEI’s mission statement is to educate stakeholders on NEI’s activities and why they are<br>important. He highlighted the work of the National Eye Health Education Partnership (NEHEP) on patient communication. At the 2023 NEHEP partnership summit in April 2023, the chef, Christin Hàwho has neuromyelitis optica, presented a talk on adapting to vision loss. Dr. Chiang also noted that Texas Congressman Pete Sessions, who launched the NEI Retinal Organoid Challenge in 2017, visited the NIH in late March 2023 and held some discussions with NEI staffers. NEI is working on identifying partner organizations who engage with vision care and research on a planned campaign to increase awareness of vision loss, the impact of vision research, and steps for maintaining eye health. Dr. Chiang then asked council members to offer feedback on what key messages should be included and what audiences should be targeted for such a campaign.</p><p><strong>Discussion</strong><br>In response to Dr. Chiang’s question, Dr. Dana suggested defining the primary purpose of such messaging. He noted that most people fear vision loss and therefore agree that eye health is important but suggested more messaging around the economic impact of vision loss, which is generally associated with aging but affects many populations beyond the elderly. With the rise in obesity and type 2 diabetes, conditions broadly associated with low socioeconomic status, increased attention on the link between diabetes and vision loss is needed. Dr. Dana also suggested that descriptions of major advances to counteract vision loss in national media could help raise public awareness.</p><p>Dr. Grant noted messaging needs to go beyond social media, which some populations, such as<br>the elderly, do not access as much as other groups. She said that even in 2023, a large number of people with eye disease do not see an ophthalmologist until the very late stages of their disease and that more gains are needed in raising awareness of vision loss and increasing access to treatments of eye disease among economically disadvantaged people or people who otherwise have less contact with the medical system. During and after the Covid-19 pandemic, virtual medicine has become more common and in-person eye care visits have become even more challenging for some patients. Mobile services or technologies such as cell phone apps that could perform basic imaging, as well as messaging on the importance of eye health, could help, she said.</p><p>One way to target communities who are less reachable through media is through institutions such as churches or libraries, Dr. Borrás added. Providing access to coaches or other people who can convey basic information could help bring awareness to medically underserved communities.</p><p>Dr. Ramulu noted the power of stories, explaining that providing information is often less effective than conveying personal narratives in which people relate their experience with eye disease and treatment. Dr. Maguire added that stories of people expressing regret about not<br>seeking care for vision loss or overlooking health practices such as controlling blood sugar could be especially powerful.<br><br>Dr. Chiang noted that bringing messages around vision health into communities is squarely within the scope of NEI’s mission, and that better storytelling and messaging could help convey what NEI does and why it matters.</p><p><strong>Recruiting the Next Generation of Vision Researchers</strong>—Dr. Chiang noted that training a diverse workforce of ophthalmologists was a core mission for NEI, but that Hispanic, Black, and Native American practitioners remain underrepresented in the field. Women and underrepresented groups also receive significantly fewer major grant awards, although their<br>success when they do is very similar to that of white male grantees. He added that more could be done to increase diversity in the pipeline of researchers applying for these grants. Many mechanisms exist to support diversity among young trainees, and it is important to make sure people know about these opportunities. Dr. Chiang posted two QR codes and a twitter handle that link to NEI extramural funding opportunities. He also noted additional outreach efforts including a very well attended symposium on grants at the 2023 ARVO meeting. He asked committee members to discuss how to ensure vision scientists or potential vision scientists learn about available opportunities.</p><p><strong>Discussion</strong><br>Dr. Coughlan noted that he knows he can reach out to NEI staff if he has questions about funding opportunities, but early career researchers might be intimidated to do so. He wondered whether it might be possible to create a chatbot that can help scientists narrow down the vast list of opportunities on the NIH website based on their specific goals.</p><p>Dr. Ramulu suggested reaching out directly to early career groups such as the Minority Ophthalmology Mentoring Program and giving presentations about available opportunities. Dr. Kowluru added that NEI staff could consider visiting and giving presentations about research opportunities at smaller institutions with especially high numbers of students from underrepresented groups, such as her institution, Wayne State University in Detroit, Michigan.</p><p>Dr. Dana noted that medical students often view ophthalmology as an elitist field, and therefore it is not attractive to trainees who seek specialties that will enable them to have a big impact on their communities. More work could be done to engage medical students and provide early exposure to ophthalmology to counter this myth and make clear that vision can be at the heart of primary care medicine.</p><p>Dr. Grant agreed that ophthalmology does not integrate well into other specialties and has not been adapted well to a primary care setting. It may be helpful to provide an introduction to the field early in students’ education, either in medical school or in graduate school. She also noted that NEI could consider holding additional, in-depth symposia on grant opportunities, beyond ones held at major meetings such as ARVO.</p><p>Dr. Mutti said that his profession, optometry, should do more to recruit at the undergraduate level, which is when talented students from underrepresented groups are often settling on career choices. Students often see medicine and dentistry as more attractive options, but optometry offers a lot of career satisfaction, he said, and experts in the field should actively encourage promising students from diverse backgrounds to consider it.</p><p>Another way to make the vision fields more attractive to young trainees is for NEI to increase its focus on funding research that addresses health disparities in communities that have been historically neglected, noted Dr. Ramulu.</p><p>Dr. Chiang thanked the committee for its valuable input and noted that NEI staff is working to offer a more intensive grants symposium before rather than during ARVO. He also wondered<br>whether imaging methods that make it possible to visualize the eye more simply could help draw more people into the field.</p><p><strong>NAEC Budget Update</strong> —Ms. Karen Colbert, NEI Budget Officer, discussed the FY2023 and FY2024 budget outlook and explained how the debt ceiling may affect NEI funding. NEI funding falls into three major buckets: Extramural research, intramural research, and research support. Estimated spending for FY2023, which aligns with funding trends over several years, suggests that 83% of NEI’s budget will go to extramural research, 12% to intramural research, and 5% to research support. In FY2023, NEI received a 3.8% increase ($32.6 million) over the previous fiscal year – the largest percentage increase in the past 5 years.</p><p>Currently, the NEI budget office anticipates a flat budget over the next two years, but a budget cut is also possible. The FY2024 President’s Budget Request for NEI is $896.1 million, unchanged from FY2023. Congress can approve, modify, or disapprove portions of the President’s Budget Request. The House Appropriations Committee has stated its intentions of curbing the federal budget and has proposed cutting the FY2024 budget to FY2022 levels. The Senate’s proposal remains to be determined.</p><p>Ms. Colbert explained that the debt ceiling is the total amount that the US government is authorized to borrow to meet its fiscal obligations. The Fiscal Responsibility Act of 2023 suspends the nation's $31.4 trillion debt limit through January 1, 2025. As part of the Act, some supplemental appropriations received by NIH institutes in response to the Covid-19 epidemic are being rescinded and the loss of those appropriations may affect NIH funding. Based on these and other factors, it is expected that budgets will be lean for at least the next couple years.</p><p><strong>Advancing Health Equity and Disparities Research in Vision</strong>—Dr. Monica Hooper, NIMHD; Dr. Stephen McLeod, University of California, San Francisco; Drs. Jimmy Le and Cheri Wiggs, NEI<br><br>Dr. Chiang introduced the session and its speakers, noting that it stemmed from a workshop that occurred in April 2023, organized by several NEI staff members with their counterparts at the National Institute on Minority Health and Health Disparities (NIMHD). This session is a direct follow-up to that workshop, addressing the question “Where do we go from here?”.</p><p><strong>Vision-related Health Disparities and Diversity in the Ophthalmology and Optometry Workforce</strong>—Dr. Monica Webb Hooper</p><p>Dr. Webb Hooper, the Deputy Director of NIMHD, began by defining the concept of health disparities, noting that they are preventable, avoidable, and rooted in disadvantage. They are also modifiable. They often intersect with race, ethnicity, and socioeconomic status, as well as with gender, sexual orientation, and other characteristics. She defined social determinants of health as the structural forces in society – for example, social, economic, and legal forces – that determine opportunities such as access to high quality jobs, education, and other factors. These things in turn impact factors such as where we live, what we eat, and how we access healthcare. Social determinants of health can be positive, but adverse ones drive health disparities.</p><p>Dr. Webb Hooper defined health equity as a guiding principle and a continuing process for centering fairness, opportunity, equality, and social justice—an ongoing effort to ensure that optimal opportunities exist for everyone to attain the best possible health. Science plays a key role in efforts to build health equity because it generates the evidence needed to inform change on a societal and an individual level.</p><p>Studies have documented notable racial and ethnic disparities in vision and eye care, with African American, Black, and Latino or Hispanic people having a higher prevalence of vision impairment than white people. Socioeconomic disparities are also present. Diabetic retinopathy, the leading cause of legal blindness in adults, has a higher prevalence in Black or African American and Mexican American populations than White populations, and its prevalence is as high as 45% in American Indian and Alaskan Native people. Disparities also exist in disease severity, screening rates, and prescriptions for vision-correcting glasses and outpatient visits for ophthalmology. Several barriers might explain disparities in access to care.</p><p>Dr. Webb Hooper described NIMHD’s research framework for health disparities and measuring demographics and health determinants. She noted that most medical research has focused on individual-level biological mechanisms, but such research overlooks many complexities that help explain poor health outcomes in people from minoritized groups. Thinking more broadly and holistically, and exploring other domains, such as the physical and built environment, sociocultural environment, and health care system effects, is critical. The NIMHD centers racism and discrimination as notable factors that affect all these issues across the sociocultural environment.<br><br>Measuring the causes and effects of health disparities in a standardized way is crucial, Dr. Webb Hooper noted. NIMHD’s toolkit for doing so, called <a href="https://www.nimhd.nih.gov/resources/phenx/">PhenX</a>, was launched in May 2020 and has since been expanded with additional protocols aimed at standardizing data collection. It exists as a resource that NEI researchers can incorporate in their work. Overall, the vision and eye care field is still relatively early in the process of incorporating health disparities into patient care, she said. In a survey of the literature, she found most studies to be squarely in the first generation of such work – understanding what disparities exist and documenting their prevalence. A few studies have entered the second generation – investigating contributing factors and the mechanisms underlying risk. Very little work enters the third generation or fourth generation realm – developing and testing interventions and implementing them at a population level.</p><p><strong>Discussion</strong></p><p>Dr. Dana noted that although it is widely appreciated that racial background in the United States is misaligned with health outcomes, and that race is not a biological determinant, but a social construct, race and ethnicity data are collected in a very binary way. Yet, socioeconomic status plays a very important role in health disparities too, regardless of skin color, but collecting such data is more complex and multifaceted. He asked how researchers could do a better job collecting data on socioeconomic status, which might inform us about providing equity and opportunity regardless of race.</p><p>Dr. Webb Hooper responded that racial categories are important because they reflect how people present in the world, which in turn affects how they are treated and assessed and how they behave. Very little data is available about people who identify as multi-racial or multi-ethnic because until recently there was not the option for people to indicate multiple heritages on medical forms and assessments. NIMHD’s PhenX tool kit includes standard categories for race and ethnicity – and measuring these self-identified features continues to be important because they affect health outcomes. Indeed, one way researchers will know when health equity is assured is that these categories will no longer be associated with health disparities. Dr. Webb Hooper noted that although socioeconomic status is a more complex variable to assess, there are common ways of doing so. For example, researchers often use individual or household income, educational attainment, occupation, whether someone is above or below the poverty line, or neighborhood characteristics as indicators of socioeconomic status. Measuring these variables in a standardized way is important so that assessments can be made over time and progress can be tracked.</p><p>Dr. Borrás asked whether data collection in studies focusing on the Latino population tracks peoples’ immigration status. People who are undocumented are often afraid to fill out health forms, so there may be less information about this vulnerable group. Dr. Webb Hooper responded that most studies do not make this distinction, though some studies funded by NIMHD focus specifically on immigrant health. She noted that she is not aware of any such studies on vision or eye care, but that the institute hopes researchers will explore those nuanced distinctions to explore how legal status affects health disparities.</p><p>Dr. Maguire referred to the four generations of health disparities research that Dr. Webb Hooper described in her talk, and noted her assessment that the eye disease field is still mainly in the first generation, of documenting and describing the barriers to health care. She asked how the field could move into later stages, of exploring interventions, and asked whether other areas of medicine that are further ahead could serve as models. Dr. Webb Hooper agreed that the prospects for doing so can seem overwhelming but noted that there appears to be enough information on documented disparities to move more actively into studies exploring why such disparities exist and thinking about interventions. She pointed to a program in Baltimore and other cities focused on creating interventions in school settings, and said it was one example that could be explored in the vision and eye care space. She said that before joining NIMHD, she had studied tobacco-related disparities, which have moved into third or fourth generation research. This involves creating culturally appropriate interventions that can work on a population level, and also ones aimed at policy, such as banning menthol in cigarettes.</p><p>Dr. Chiang noted that one limitation he sees in research on disparities is that it often does not integrate different underlying causes of disparities into a holistic approach. Dr. Webb Hooper agreed, noting that an important aspect of NIMHD’s framework is to encourage researchers to move beyond their silo and instead take a more whole-person approach. She and her colleagues at the institute hope that over time, more projects will encompass multiple domains. For example, looking at how interventions targeting individual level behavior change play out at the community level, or how to effect change within the health system itself.</p><p><strong>Vision, Health Disparities, and Health Equity at the Intersection</strong>—Dr. Stephen McLeod<br>Dr. McLeod, who is the Chief Executive Officer of the American Academy of Ophthalmology, described perspectives on health disparities from the care delivery community and the American Academy of Ophthalmology. A framework for health inequity that resonates with the Academy is one proposed by health equity researcher Paula Braverman at the University of California, San Francisco: “A systematic, potentially avoidable difference in health between groups of people of different relative positions, and so, hierarchies according to wealth, power and prestige.”</p><p>Dr. McLeod noted that health equity requires a continual process of examining opportunity and care delivery systems. He also discussed the role of race in health disparities, noting that it conflates three different epidemiologic features. One is that it serves as a proxy to a lot of other issues, for example, education, built environment, poverty, or insurance access. Another is that even though race is a social construct, there are some messy underlying genetic components.</p><p>Finally, there is also the issue of racism itself. Teasing out how all these issues affect health disparities in a more granular way would be helpful.</p><p>The Academy convened a task force on health disparities that culminated in a series of publications that came out last year. The goal was to examine the extant literature, examine where we are right now and try to identify knowledge gaps and to create a roadmap for moving the field forward into studies on interventions. Although disparities do exist, he said, the gap seems to be narrowing. In addition to drivers like low income, unemployment, lower education, and lack of health insurance, there were also geographic factors, with a much more elevated incidence of blindness and visual impairment in the South. Dr. McLeod also noted one study that looked at how the Affordable Care Act affected utilization of diabetic retina exams. In areas where access to care became easier through the ACA, researchers observed an initial increase in adherence to diabetic screening guidelines, but it soon tapered. The study indicated that a lot of structures must be put in place besides simply insurance access to achieve health goals.</p><p>Recognizing the gaps that exist, the Academy feels that much more extensive data will need to be gathered to better understand the risks underlying health disparities and to design appropriate interventions. The Academy aims to expand the social determinants captured in its IRIS Registry, the nation’s first comprehensive eye disease clinical registry, and other data sets will also help, including NIH’s All of Us. It turns out that ophthalmology and optometry is one of the most common ways that of people enter the healthcare system, so the vision field is actually helping to recruit a lot of All of Us participants.</p><p>Dr. McLeod ended by underscoring the Academy’s commitment to addressing health equity in vision and eye care. He noted that this will require extensive documentation of inequalities with good data, understanding the mediators of health disparities, and identifying how they can be modified. An additional critical component is educating the care delivery community about health disparities.</p><p><strong>Discussion</strong></p><p>Dr. Chiang noted that he appreciated Dr. McLeod’s comment on how often the optometrist or ophthalmologist is a person’s first contact with the health system.</p><p>Dr. Coughlin asked how disability and conditions such as depression and anxiety might play into health disparities. Dr. McLeod noted that this was an important point, and that data should be collected as broadly as possible. He noted that finding clinics that can provide consistent eye care for adults with disabilities such as Down Syndrome is very challenging.</p><p>Dr. Kowluru noted that access to health care and health insurance issues are big challenges that are discussed a lot, and asked how clinicians and researchers might address them. Dr. McLeod said that one of the responsibilities of the profession is to play a part in the entire continuum, from supporting science directed toward public health outcomes to serving as advocates at the state and federal level for making changes in the care delivery system.</p><p>Dr. Grant asked why the vision and eye care community, as a whole, has seemed reluctant to go into the community – in the way that mobile blood banks do. The absence of community involvement is especially surprising given that this field of healthcare targets visually impaired patients who often have trouble getting transportation. Dr. McLeod noted that outside of the pediatric population, routine screening is not well established. There are some mobile programs out there but it’s not clear how effective they are. A problem in integrating vision care into the primary care environment is that the equipment takes up a lot of room and can’t be used for anything else, so it’s expensive in terms of needed infrastructure. Also, people who get their medical care in the community – say, at federally-funded government clinics-- tend to be the most vulnerable patients who are living well below the poverty line, for whom English is a second language. Very few of those clinics offer vision care. It’s crucial to understand these hurdles to do a better job of delivering care in the primary space, particularly to the most vulnerable patients.</p><p><strong>Advancing Health Equity and Disparities Research in Vision</strong>—Drs. Jimmy Le and Cheri Wiggs</p><p>Dr. Le noted that health disparities are preventable, and that working to eliminate them is the right thing to do. In 2021, under Dr. Chiang’s leadership, NEI published its vision for the future, which for the first time outlined a strategic plan in which addressing health disparities is a core area of emphasis. NEI continues to recognize that eliminating vision loss and improving quality of life involves conducting research that probes the cause of health disparities and identifies ways to promote health equity.</p><p>Between 2018 and 2022, NEI has supported several projects that seek to document and better understand health disparities. Dr. Le described a handful of illustrative examples and noted that NEI has set out to shift its research on health disparities from documenting pervasiveness to a more inclusive, multidisciplinary approach that is centered on removing barriers and promoting equity. He also presented a Notice of Funding Opportunity to support vision research focused on promoting equity.</p><p>Dr. Wiggs then described the roots of NEI’s workshop on health disparities, noting that they set out to understand challenges in understanding vision health disparities and to learn about strategies that have been successful in integrating social determinants of health in different research areas and how such strategies could be integrated into vision research. The workshop, held in April 2023, consisted of 23 participants, addressed two main discussion topics. The first of these involved pinning down the etiology of health disparities in vision and understanding what is currently known, what new types of data need to be collected, and how to promote research collaborations that would fill in the blanks.</p><p>A key challenge that participants brought up was the real-world complexity of health disparities. There are multiple drivers of health disparities and many of them are interconnected, making it challenging to differentiate them. Participants also noted the challenge of navigating misconceptions about the subject and an overemphasis on biological research. Participants also noted that studies often use inconsistent criteria and terminology, and that certain communities were not fully described by the data. However, since vision health is a part of overall health, participants agreed that datasets and approaches from other health related realms, particularly cancer, could inform how studies relating to vision are designed.</p><p>The second main topic of the workshop discussion was examining interventions that could advance health equity. In six presentations and a discussion, the group sought insights on what types of interventions have succeeded, how to develop new ones, and what strategies could be used to successfully implement them. Here, too, a major challenge is that there are multiple levels of causes underlying health disparities, but many existing efforts have defaulted to an individual level of intervention, which does not address the real-life complexity of the problem. Another issue is that interventions are often tested without clearly defining outcome measures, so evaluating their effects is difficult. Another difficulty is that communities experiencing high levels of health disparities often lack trust in medical research, and there is an overall waning trust in public health institutions, which impacts efforts to cultivate community engagement.</p><p>Participants noted that efforts to test interventions should move beyond typical randomized controlled clinical trials and should embrace community based participatory research. Using well-defined patient-centric outcome measures, including quality of life reporting, was also deemed crucial. Adding eye health to the mainstream public health agenda may also be extremely important. Although there is a lack of strong evidence that vision screening is useful in eye health, that could be because screening quality is poor or because it so infrequently leads to follow-up care. Ensuring access to eye care – through new technologies, telemedicine or helping people navigate the healthcare system – should also be a focus.</p><p><strong>Discussion</strong></p><p>Dr. Dana asked Dr. McLeod whether the association is working with the American Academy of Optometry on health equity efforts. He also asked what specific fields of healthcare have been successful in identifying and addressing health disparities. Dr. McLeod confirmed an ongoing partnership with the American Academy of Optometry. He also noted that exploring best practices in other fields of medicine had been a focus of the NEI workshop. Cancer care, in particular has wrestled with these issues productively, he said, but vision and eye care has much to learn from other fields as well.</p><p>Dr. Grant spoke to a point Dr. McLeod made earlier, about the fact that the equipment needed for eye care was cumbersome and space-intensive, making it not generally cost effective for primary care practices to offer vision care. She noted that today, tools for basic eye care can be integrated into a cell phone app, and posited instead that ophthalmology is reluctant to yield control over eye care to primary care specialists. Dr. McLeod contested her point, saying that ophthalmologists would love to have the primary care community play a larger role in eye care but that doing so has been a major struggle. He noted that efforts to incorporate ophthalmology into the medical school curriculum, to include it in family practice training or making emergency room physicians more comfortable with providing eye care have faced an uphill battle. He added, though, that miniaturization of technology does provide an opportunity, and that ophthalmology as a field needs to figure out how to harness these advances in closing the eye care gap.</p><p>Dr. Gardner noted that while the discussions around health disparities in eye care seem valuable, there appeared to be a lack of achievable quantifiable objectives or discrete milestones that would indicate progress. Dr. McLeod responded that in order to see quantifiable improvements, health equity had to be a programmatic imperative. He noted that the American Academy of Ophthalmology had been working closely with Federally Qualified Health Centers (FQHC), a set of nonprofit clinics established in medically underserved areas, because an aim of the FQHC project is to identify metrics for measuring success. Establishing such tangible measures is something that the vision care community will have to do in order to come up with a roadmap of interventions that can be rolled out to large communities and demonstrate impact. Dr. Le added a point that Dr. Webb Cooper made in her talk – that health equity is not an outcome but is a continuum. He noted that simply measuring disparities risks neglecting their root causes.</p><p>Dr. Mutti said that visual screening seemed like a concrete measure, and that he was surprised by the comment that it is not considered effective. He asked why that might be. Dr. Wiggs replied that many possibilities were discussed at the workshop. One reason is that screenings are only as good as the follow-ups to them, yet getting follow-up care for vision and eye health is often extremely challenging. Dr. McLeod raised another concern - that primary care physicians are not always comfortable with conducting such screenings and so the results can be very noisy. Also, while a screening can point to a concern, it does not actually diagnose a problem. Many more steps are needed for diagnosis and treatment to occur, so making the connection between screening and a positive health outcome can be challenging.</p><p>Dr. Grant noted that in the past, the number of patients that were seen pro bono in university settings seemed much higher. She wondered whether more patients were now being turned away from pro bono care and asked whether the economics of taking care of underserved patients had changed. Dr. McLeod said that academic health centers across the country are indeed now feeling more of a squeeze and there is increasing stress in terms of providers willing to see Medicaid patients.</p><p><strong>Concept Clearances</strong></p><p><strong>NEI SBIR Clinical Trial Cooperative Agreement</strong>—Dr. Paek Lee</p><p>Dr. Lee presented a concept for “NEI Small Business Innovation Research (SBIR) Clinical Trial Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk.”</p><p>The initiative aims to support early-stage, investigator-initiated clinical trials with a risk level greater than the magnitude of harm or discomfort that people ordinarily encounter in the course of daily life or routine physical or psychological tests. Currently NEI only accepts applications for minimal risk clinical trials under SBIR and STTR (Small Business Technology Transfer) funding opportunities. Trials with greater than minimal risk are supported by U01 and UG1 cooperative agreement mechanisms. But those funding opportunities are not designed to support expedited and commercialization-oriented trials.</p><p>This initiative will fill that gap by supporting 2-3 year trials that investigate the safety and/or efficacy of screening, diagnostic, preventative or therapeutic interventions. It is intended for early-stage trials with strong preliminary or preclinical data. Examples include invasive ocular implants, invasive surgical or diagnostic instruments, or early-stage therapeutic drugs, biologics, or devices.</p><p><strong>Discussion</strong></p><p>Dr. Grant asked Dr. Lee to define the size of the company. He says the eligibility requirements state the company must have 500 employees or fewer.</p><p>Dr. Maguire appreciated the spirit of the proposal of expediting and moving things along quickly and she expressed hope that this attitude could be moved to the non-SBIR side of the aisle as well.</p><p>A motion to approve this concept for potential development was made, seconded, and approved unanimously.</p><p><strong>Stimulating Access to Research in Residency (StARR)</strong>—Dr. Neeraj Agrawal</p><p>Dr. Agrawal said the StARR program is an existing funding opportunity from the Heart, Lung and Blood Institute – R<a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-23-006.html">FA-HL-23-006</a>. He explained that this is not technically a concept clearance because NEI is requesting council approval to join this funding announcement.</p><p> </p><p>StARR is an institutional research training program for residents, analogous to the NEI K12 program. The funding program is used by several other institutes. It supports institutional, mentor training programs that engage residents in research. It provides salary support and expenses for 1 to 2 years of research for resident-investigators. The overall aim is to increase the numbers of trained clinician scientists engaged in vision research and to promote their career development.</p><p>This funding opportunity aims to solicit applications from institutions to provide outstanding and immersive mentored research opportunities for ophthalmology residents who wish to conduct research, and to foster institutions’ ability to transition resident-investigators to individual career development research awards.</p><p>This funding opportunity provides support for a variety of supplemental research and professional development activities, including technical support, participation in short-term courses or workshops on research skills, training on oral and written research communication, and travel to scientific conferences and NIH-sponsored workshops.</p><p>The program has been very successful for the current participating institutes. Since ophthalmology is a smaller field, NEI expects to support two residents per year and anticipates that about 10 institutions will apply.</p><p><strong>Discussion</strong></p><p>Dr. Dana said the opportunity sounded very interesting, but many details remain to be worked out. He confirmed that the current K12 program supports 2-4 residents per year per institution. More than 95% of ophthalmology residents say they want to be physician scientists, but not more than half actually go on to do research. This mechanism could permit applicants to claim how interested they are. He noted though, that because it is a small field, some years there might not be any participants in the program.</p><p>Dr. Grant asked whether the research could occur during a gap year or two between residency and fellowship. Dr. Agrawal said that this will occur during residency.</p><p>Dr. Mutti asked Dr. Agrawal to confirm whether the program would also open to optometry residents, and Dr. Agrawal confirmed that it would.</p><p>Dr. Ramulu asked what the vision for the clinical training would be. Dr. Agrawal said it would be up to the program and the candidate.</p><p>Dr. Gardner said this program would be a fantastic bridge to allow people to start their research training. He made a plea for the execution to be as flexible as possible. Dr. Agrawal agreed.</p><p>Dr. Grant noted that it would be great for people coming into ophthalmology research after finishing their residency training in other fields. Dr. Agrawal said that this would be open to any medical residency who wanted to engage in vision research.</p><p>Dr. Maguire asked whether the applicant programs would be required to have an educational component in place, offering courses and workshops for career development. Dr. Agrawal said that institutions would have to show this component in their application.</p><p>Dr. Anderson noted that this training was to allow people who may have never been in a lab to gain that experience. She noted that council members suggested that NEI should consider allowing residents to do this program before or after their clinical training, and not just during their residency. She also noted that council members suggested that NEI consider opening the program to residents in other fields interested in conducting vision-related clinical research.</p><p>A motion to approve that NEI participate in this funding opportunity was made, seconded, and approved unanimously.</p><p><strong>General Discussion</strong></p><p>Dr. Maguire asked whether Notices of Special Interest (NOSIs) are given any special<br>consideration in any study sections. Dr. Anderson replied that because NOSIs are not RFAs, they are reviewed in study sections and reviewers are not given any special instructions for evaluating them. If prospective grantees include a NOSI’s number on the grant application, NEI program staff can flag those grants and give them priority.</p><p>Dr. Dana wanted to return to the topic of stem cell and regenerative therapies. He reminded the council that the first successful allotransplant was a cornea as a restorative transplant. Also, the first successful stem cell application clinically, anywhere in any tissue was also ocular, in 1988. The first topical biologic for regeneration was also ocular – recombinant NGF for the cornea and ocular surface. A therapy approved in March 2023 in Japan is the first allogenic cell therapy to treat corneal endothelial disease. He noted that it is important to consider that there is more to regenerative therapy in the eye than retinal ganglion cells. New delivery mechanisms, as well as therapies that restore the microenvironment, are also important areas to explore. He noted that currently there is inadequate attention to these areas of regenerative therapy, and industry has picked up on that.</p><p>Dr. Chiang responded that NEI agrees that cellular therapy is not limited to the retina. He noted that NEI also has an anterior segment initiative and consortia looking at neural pathways at the ocular surface. He underscored the importance of the microenvironment, and the immune response to the success of regenerative therapies.</p><p>Dr. Kowluru asked about the collaboration between NEI and DoD. Dr. Chiang noted that the entry point to these grants is through DoD. Dr. Gover said that the funding mechanism is not reciprocal – that NEI is allowed to pick up grants submitted through this collaboration, but if a grant comes in through NEI there is no mechanism for the DoD to pick it up.</p><p>Dr. Grant asked about opportunities for mid-career and senior investigators to do career development – for example, acquiring training on new techniques that could expand an investigator’s career in a new direction. Dr. Agrawal replied that NEI used to participate in the K24 program, which enables such training, but does not anymore. Dr. Anderson said that in the past, institutions had more mid-career mentored awards, but institutions have moved away from this because they want to devote more resources to early career investigators.</p><p>Dr. Ramulu said that it was interesting to hear Dr. Chiang lay out NEI’s accomplishments and that many of them (say, traumatic brain injury) do not have to do with eyes. He asked Dr. Chiang whether the NEI is doing a good enough job messaging the idea that it is not just an eye institute but actually a vision institute. Dr Chiang noted that “eye institutes” often get siloed, but that scientists thrive when they work within the larger milieu of science and medicine. He agreed that it was important to make this message clear and asked committee members for their advice on how to do so.</p><p>Dr. Grant raised the topic of grant projects and an idea Dr. Chiang mentioned, of potentially enhancing team science by bringing together a team of researchers around a disease rather than having them each working under disparate grants. Dr. Chiang noted that he did not have specific research mechanisms in mind but believed that overall, the vision science community will thrive if researchers build connections between related topics linked by a common goal.</p><p>Dr. Anderson adjourned the open session meeting at 2:30pm.</p><p> </p><p><strong>CLOSED SESSION</strong></p><p> </p><p>This portion of the meeting was closed to the public in accordance with the determination that<br>this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of the Federal Advisory Committee Act, as<br>amended (5, USC Appendix 2). Members absented themselves from the meeting during<br>discussion of and voting on applications from their own institutions or other applications in<br>which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.</p><p><strong>REVIEW OF APPLICATIONS</strong><br>NAEC members considered 539 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $185,144,084 (direct costs year 01). The<br>Council also considered 306 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $228,975,536 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 845<br>applications.</p><p><strong>ADJOURNMENT</strong><br>The 165th meeting of the National Advisory Eye Council was adjourned at 4:30 p.m. on June 16, 2023.</p><p><strong>CLOSED SESSION ATTENDEES</strong></p><p><strong>Council Members Present:</strong><br>Dr. Michael F. Chiang, Chair (in-person)<br>Dr. Kathleen Anderson, Executive Secretary (in-person)<br>Dr. Terete Borrás (in-person)<br>Dr. James Coughlan (in-person)<br>Dr. Reza Dana (in-person)</p><p>Dr. Thomas Gardner (in-person)<br>Dr. Maria B. Grant (in-person)<br>Dr. Renu Kowluru (in-person)<br>Dr. Maureen Maguire (in-person)<br>Dr. Donald Mutti (in-person)<br>Dr. Pradeep Ramulu (in-person)</p><p><strong>NIH Staff Members Present:</strong></p><p>Dr. Neeraj Agarwal (in-person)<br>Lisa Applewhite (in-person)<br>Dr. Houmam Araj (virtual))<br>Dr. Sangeeta Bhargava (in-person)<br>Nathan Brown (in-person)<br>Donald Everett (in-person)<br>Dr. Martha Flanders (virtual)<br>Dr. Ashley Fortress (virtual)<br>Dr. James Gao (virtual)<br>Dr. Shefa Gordon (in-person)<br>Dr. Tony Gover (in-person)<br>Lateefah Hill (in-person)<br>Dr. Brian Hoshaw (in-person)<br>Dr. Alicia Kerr (virtual)<br>Dr. Jimmy Le (in-person)<br>Dr. Paek Lee (in-person)<br>Dr. Ellen Liberman (in-person)<br>Dr. George McKie (in-person)<br>Dr. Lisa Neuhold (in-person)<br>Dr. Mary Ann Redford (virtual)<br>Dr. David Schneeweis (in-person)<br>Dr. Jennifer Schiltz (in-person)<br>Dr. Grace Shen (in-person)<br>Karen Robinson Smith (virtual)<br>Dr. Hongman Song (virtual)<br>Dr. Afia Sultana (virtual)<br>Dr. Santa Tumminia (in-person)<br>Dr. Cheri Wiggs (in-person)</p><p><strong>CERTIFICATION</strong><br>These minutes were submitted for the approval of the Council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.</p><p> </p><p>______________________________________<br>Michael F. Chiang, MD<br>Chair<br>National Advisory Eye Council</p><p> </p><p>______________________________________<br>Kathleen C. Anderson, PhD<br>Executive Secretary<br>National Advisory Eye Council</p>
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