DECEMBER 2020. Thousands of individuals who live in New York City’s public housing developments will receive free vision screenings, eye glasses, and essential follow-up eye care, all within their own apartment complex, as part of a new community-based initiative headed by Columbia Department of Ophthalmology researchers and funded by the Centers for Disease Control and Prevention (CDC). The Manhattan Vision Screening and Follow-Up Study in Vulnerable Populations is a 5-year, randomized controlled trial, open to any New York City resident over 40 years of age living independently in one of ten adult and senior housing buildings owned by the New York City Housing Authority (NYCHA), one of Columbia’s partners for the study.
Lisa Hark, PhD, RD with resident
“The four leading causes of blindness in the United States are diabetic retinopathy, glaucoma, age-related macular degeneration (AMD), and cataracts,” says lead investigator Lisa Hark, PhD, RD, Professor of Ophthalmic Sciences (in Ophthalmology), who directs the Department of Ophthalmology’s Clinical Trials Unit. Without interventions, vision impairment and blindness caused by these four conditions are expected to increase 150% by 2050. “These eye conditions disproportionately affect low-income and vulnerable populations, and can often be treated effectively if diagnosed early, preventing blindness.
But the biggest barrier is follow-up care. Fewer than 40% of people follow up and get effective ocular treatment after an abnormal vision screening.” That low follow-up rate is not because these individuals don’t want to take care of their vision. “People in underserved communities face child care burdens, insurance limitations, transportation challenges, and employment issues. It’s hard to get to an eye doctor’s appointment if your boss tells you you’ll be fired for taking two hours off,” says James Auran, MD, Professor of Ophthalmology, who served as Chief of Ophthalmology at Harlem Hospital. “And people may not understand why they need an eye exam if they have not yet noticed any vision changes. All this means that there are many people with undiagnosed and untreated eye conditions outside of our health care system in desperate need of vision care.”
The study aims to reach people by conducting vision screenings where they live, in the community room or senior center located in the lobby of their own apartment buildings. Its protocols have been adapted for the COVID-19 pandemic, and investigators have been approved by the Institutional Review Board (IRB) to obtain consent from residents over the telephone. During this phone call, residents are asked about their ocular, medical, and family history, vision-related quality of life and history of falling. Once this pre-check is completed, residents are scheduled for a 30-minute in-person vision screening that includes a visual acuity check using the standard Snellen chart, eye pressure. Individuals with abnormal vision screening results will be scheduled for follow-up eye exam appointments with optometrist Y. Shira Kresch, OD, MS, FAAO, Instructor in Optometric Sciences (in Ophthalmology).
L. to R.: Lisa Hark, PhD, RD and Y. Shira, OD, MS, FAAO
Residents in seven of the 10 buildings will be randomized to the “enhanced intervention” arm of the study. Those who are referred to an ophthalmologist will be scheduled for an eye exam at the Harkness Eye Clinic or Harlem Hospital Ophthalmology and guided through all aspects of follow-up eye care by patient navigators. Residents who need vision correction will receive free eye glasses, provided by Warby Parker. “If these individuals do not attend follow-up appointments, the navigators will reach out to help them reschedule. They will also assist with logistical and scheduling hurdles, such as transportation and making eye exam appointments,” says Dr. Hark. Such navigators have proven effective in cancer care.
Residents in three of the 10 buildings will serve as the study’s control arm. If they fail the screening and require an ophthalmology consultation, they will have their ﬁrst appointment made for them, either at the Harkness Eye Clinic or at Harlem Hospital Ophthalmology, but they will not be given the enhanced navigator support. If they attend this appointment, and need vision correction, they will receive a prescription for eye glasses and a list of nearby optical shops. All enrolled residents in both the intervention and the control group will receive a follow-up phone call at 12 months after their vision screening to schedule an eye exam.
A pilot phase of the study was conducted in February at the Riverstone Senior Center, which is operated by the city’s Department for the Aging (DFTA). (Because this phase took place prior to the pandemic, all visits were conducted in person.) During the pilot, 42 people were screened, and 33 of them—nearly 80% of participants—failed their initial vision screening and were referred to the “on-site” optometrist, Dr. Kresch, for an eye exam. Of the 33 who were referred to Dr. Kresch, 28 attended their appointments and 18 were referred to ophthalmology.
Dr. Kresch, study optometrist, using a portable slit lamp in the community.
“We were very pleased with how many patients attended their optometrist exam,” Dr. Hark said. “Because this was a pilot phase of the study to assess our procedures, we did not have a control arm; everyone received navigator support. We provided free eyeglasses to 13 study participants.” Participants were highly satisﬁed with their experience. When asked how likely they would be to attend a referred appointment with an ophthalmologist, 89% said “very likely,” and 88% said that they were also very likely to recommend the vision screening to family, friends, and neighbors.
Dr. Hark expects approximately 1,500 residents across 10 NYCHA buildings to participate in the vision screening during the 2-year recruitment phase. All enrolled residents will then be followed prospectively for one year to evaluate the effects of the intervention on visual acuity and health-related quality of life, as well as secondary outcomes including adherence to follow-up appointments and cataract surgery, risk and rates of falls, and participants’ satisfaction rates. “This study is innovative, longitudinal, and can be easily scaled up,” Dr. Hark says. “It’s a great way to reach vulnerable populations and get them the vision care they need by making it very easy and convenient.
If we are successful at detecting new cases of eye disease and improving follow-up eye care in a cost-effective manner, the CDC would like to expand the program in New York City and replicate it in other cities.” Therefore, Dr. Hark has also partnered with Assaf Zeevi, PhD, Kravis Professor of Business at Columbia University and Laura Pizzi, PharmD, MPH, Director, Center for Health Outcomes, Policy, and Economics at Rutgers University, to conduct an economic analysis of the cost per case detected in the community for these leading causes of eye disease.
Dr. Auran predicts that the project will be very successful. “Community vision screenings, which we already conduct frequently, identify many patients with the kind of vision conditions Dr. Hark hopes to identify and treat,” he says. “But many of these people are outside the system. They may not even have a working phone number. Intensive follow-up with a navigator who can shepherd people through a complex and confusing health care system, and all the personal obstacles they may face accessing care, will be a game-changer for this community. It’s the first time I know of that anyone has undertaken an initiative of this kind to prevent blindness.”
In addition to NYCHA, other partners in the study who are represented on the Advisory Board include the New York City Department for the Aging, the New York City Department of Health and Mental Hygiene, the New York Academy of Medicine, the New York City Health and Hospitals Corporation/Harlem Hospital, the New York-Presbyterian Ambulatory Care Network, City University of New York School of Medicine, the Lighthouse Guild, Live-On New York, Warby Parker, Volk Optical, Inc. and VISIONS/Services for the Blind and Visually Impaired.
Dr. Hark is also contracting with Westat, Inc. to conduct the study evaluation over five years. Dr. Hark’s co-investigators at Columbia University include Dr. Auran; Dr. Kresch; Jeffrey Liebmann, MD, the Shirlee and Brown Professor of Ophthalmology, Glaucoma Service Director, and Vice-Chair of the Department of Ophthalmology; C. Gustavo De Moraes, MD, MPH, Associate Professor of Ophthalmology and Medical Director of the Clinical Trial Unit; Lisa Park, MD, Associate Professor of Ophthalmology; Jason Horowitz, MD, Associate Professor of Ophthalmology and Medical Director of the Harkness Eye Clinic; Noga Harizman, MD, Associate Professor of Ophthalmology; Prakash Gorroochurn, PhD, Associate Professor of Biostatistics at the Columbia University Mailman School of Public Health; and Olajide Williams, MD, MPH, Associate Professor of Neurology and Co-Director of the Columbia Wellness Center.
Stella Stempel, MSW, Stefania Maruri, BA, Elizabeth Stidham, BS, and Aisha Banks, BA are serving as study coordinators. In addition, numerous Columbia University experts are serving on the Advisory Board, including representatives from the School Nursing, Mailman School of Public Health, Office of Government and Community Affairs, and Occupational Therapy Programs.
L. to R.: Stefania Maruri, BS, Stella Stempel, LCSW, Lisa Hark, PhD, RD, and Bianca Lambert, MD, MS