Columbia University
Lisa Hark, PhD, MBA
Our team of vision researchers have designed the Eye Health Intervention Study in Upper Manhattan (EYES-UM) to provide eye health screenings to individuals living in Upper Manhattan. The proposed innovative, 2:1 cluster-randomized clinical trial, will recruit adults age 40 and older in Upper Manhattan with known rates of inadequate eye care. A total of 10 settings in Upper Manhattan, comprised of primary care offices, senior centers, and organizations, confirms access to 17,000 individuals living at or below the NYC.gov poverty measure. This study will conduct ocular tests (visual acuity, intraocular pressure, fundus images) during screenings. To ensure that all participants receive the basic level of service, all participants who fail the eye health screening will be seen the same day by a study optometrist and eyeglasses will be provided at no charge. Educational workshops and an Advisory Board will support recruitment. Intervention Arm participants will receive ongoing support with scheduling eye exams and transportation by trained Study Coordinators. All participants will be followed prospectively for 2 years. The study is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework. An economic analysis will be conducted to evaluate the costs and benefits of the proposed multi-level Eye Health Screening Intervention. This will include calculating the cost per case of eye disease detected (such as glaucoma, cataracts, and retinal conditions) and assess the cost-effectiveness of the Intervention in comparison to Usual Care.
Glaucoma, Suspect
Diabetic Retinopathy
Cataract
Refractive Errors
Vision Impairment and Blindness
Intervention
Usual Care
NA
The investigators and an interdisciplinary team with experience in clinical research, ophthalmology, optometry, biostatistics/data analysis, implementation science, mixed-methods epidemiology, and health economics designed the study to promote eye and vision health in adults and their families. This is an innovative study with a 2:1 cluster-randomized clinical trial enrolling individuals living in Upper Manhattan with inadequate eye care. A total of 10 settings, consisting of primary care offices, senior centers, and organizations, will be included to give access to 17,000 individuals at high-risk of eye disease. Clinical measures (visual acuity, intraocular pressure, fundus images, visual field test and contrast sensitivity), and quality-of-life will be assessed. All participants referred to ophthalmology in the Intervention Arm will receive assistance from a Study Coordinator with scheduling an initial in-office eye exam appointment and arranging transportation to these appointments over 2 years.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 5840 participants |
| Masking : | SINGLE |
| Masking Description : | Ophthalmologists reading the fundus images will be masked to randomization assignment. |
| Primary Purpose : | SCREENING |
| Official Title : | Eye Health Intervention Study in Upper Manhattan |
| Actual Study Start Date : | 2026-04-01 |
| Estimated Primary Completion Date : | 2031-03-31 |
| Estimated Study Completion Date : | 2031-03-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 40 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Welsh / nyph
New York, New York, United States, 10032