Eye Health Intervention Study in Upper Manhattan

Summary

Individuals living in Upper Manhattan have limited access to eye care, high vision impairment rates, and poor ocular health outcomes. To improve eye care and vision health outcomes, the Eye Health Intervention Study in Upper Manhattan (EYES-UM) will conduct eye health screenings in accessible primary care health centers and senior centers and implement a behavioral intervention to improve adherence for those referred for in-office eye care. 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. Conducting Focus Groups with health policy stakeholders ensures iterative input during the study to bridge and translate EYES-UM findings into a Vision Health Policy Roadmap for scalable implementation of vision care delivery models, focusing on adherence.

Conditions

• Glaucoma, Suspect
• Diabetic Retinopathy
• Cataract
• Refractive Errors
• Vision Impairment and Blindness

Interventions

OTHER

Intervention

Participants randomized to the Intervention Arm and referred to ophthalmology will receive assistance from a Study Coordinator with scheduling in-office eye exam appointment and arranging transportation to these appointments over 2 years at either Columbia Ophthalmology, Harlem Hospital, or their own eye care provider.

OTHER

Usual Care

Consented participants randomized to the Usual Care Arm will receive all the basic level of services including the eye health screening, optometric exam if they fail the screening, and eyeglasses at no charge. Those who require referral to ophthalmology will be scheduled for the initial in-office eye exam and their outcomes will be tracked. No additional support will be provided the Usual Care participants during the study. The Usual Care Arm represents a realistic choice currently available for participants following eye health screening.

Sponsors & Collaborators

• National Eye Institute (NEI)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Lisa A. Hark, PhD, MBA · Columbia University Department of Ophthalmology

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2031-03-31

Completion

2031-03-31

Countries

• United States

Study Locations