Glaucoma is a chronic optic neuropathy resulting in visual field defects, progressive vision loss, and blindness. In the United States, glaucoma is the leading cause of blindness in African Americans. African Americans develop glaucoma at a younger age, progress more rapidly, and are almost 7 times more likely to go blind than non-Hispanic Whites. Rates of glaucoma are projected to increase by 50% to 3.36 million people by 2020. The increasing prevalence of glaucoma is expected to cause a significant economic and quality-of-life burden, therefore, we have designed the Manhattan Vision Screening and Follow-up Study in Vulnerable Populations, a cluster randomized controlled trial, to identify and implement innovative strategies to engage populations most at risk, most vulnerable, and least likely to have access to eye care. The study population is comprised of disadvantaged men and women ?40 years old of diverse race/ethnicity (primarily African American and Hispanic/Latino), with high rates of inadequate eye care, living in affordable housing buildings in New York City. Participants randomized to Enhanced Intervention Using Patient Navigators Arm 1 (7 buildings) who fail the screening and need vision correction will receive free eye glasses. If they are referred to an ophthalmologist, they will receive enhanced support with patient navigators over 2 years to assist with all aspects of follow-up eye care, specifically appointment scheduling and arranging transportation to eye exams and cataract surgery. Participants randomized to the Usual Care Arm 2 (3 buildings) who fail the screening and need vision correction will be given an eye glasses prescription only and a list of optical shops. All participants who pass and/or fail the vision screening in both arms will be invited to the 12-month and 24-month vision screening, which will take place at the same housing buildings. We will follow participants prospectively for 2 years to evaluate the effects of the intervention on presenting visual acuity and health-related quality-of-life (primary outcome), adherence to follow-up eye care and cataract surgery (secondary outcome), falls risk and rates of falls (safety outcomes), and participants? satisfaction following screenings.
The aims of the study are: 1) Develop and implement an innovative, community-based vision screening and follow-up study where people live to increase engagement, detection and management of glaucoma, vision impairment, cataracts, and other eye diseases in vulnerable populations living in New York City affordable housing buildings; 2) Evaluate the effectiveness of an enhanced intervention using patient navigators to improve visual acuity, adherence to follow-up eye care and cataract surgery, and quality-of-life in vulnerable populations living in New York City affordable housing buildings; 3) Conduct an economic analysis of the costs and benefits of the proposed approaches to examine the cost of the screening and intervention, cost per case detected, and the cost- effectiveness of the Intervention vs. Usual Care Arms; and 4) Replicate, scale, and disseminate protocols, materials, and manuscripts.
Columbia University in the City of New York proposes a new public health model to increase engagement, detection, and management of glaucoma, vision impairment, cataracts, and other eye diseases in vulnerable populations in New York City. With the support of government, community, University, and industry partners, Columbia University Irving Medical Center Department of Ophthalmology has designed the Manhattan Vision Screening and Follow-up Study in Vulnerable Populations, a cluster randomized controlled trial, to identify and implement innovative strategies to engage populations most at risk, most vulnerable, and least likely to have access to eye care. The study population is comprised of disadvantaged men and women ?40 years old of diverse race/ethnicity (primarily African American and Hispanic/Latino), with high rates of inadequate eye care, living in affordable housing buildings in New York City.
