Eye Health Intervention Study in Upper Manhattan

NCT06112431 | Not Yet Recruiting DMC

• 2 other identifiers: AAAV6542PA-25-305
• Study Type: interventional
• Target: 5,840
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Randomized Clinical Trial; Implementation Outcomes; Eye Health Intervention; Glaucoma/Glaucoma Suspect; Eye Health Screenings and Optometric Exams; Leading Causes of Eye Disease; Telehealth Image Reading; Vision Health Policy Roadmap

Outcome Measures

Primary Outcomes (2)

• Primary Implementation Outcome: Adherence to IN-OFFICE Eye Exam for those referred to ophthalmology

  The primary implementation outcome measure for Aim 1 is ADHERENCE TO IN-OFFICE eye exam for those referred to ophthalmology and will be measured by appointment attendance at the initial in-office eye exam appointment for those referred to ophthalmology. The unit of measure is the eye exam appointment, which will be scheduled within 6-months (+/-4 months) of the referral at either Columbia Ophthalmology, Harlem Hospital or their own eye care provider. The measure will assess the rate of adherence at the initial appointment. Comparisons will be made between the Intervention Arm and the Usual Care Arm.

  2 years

• Primary Clinical Effectiveness Outcome: Detection of Eye Disease

  The primary clinical effectiveness outcome measure for Aim 1 is detection of eye disease(s) (glaucoma, retina, other) confirmed by in-office eye exams and will be measured by rates of detection of eye disease(s) for those referred to ophthalmology. All initial in-office eye exams will be scheduled at the conclusion of eye health screenings. Outcome measures will assess rates of eye disease detection, specifically glaucoma/suspect, among those referred to ophthalmology. A comparison will be made between participants living in the 7 health settings randomized to the Intervention Arm compared to 3 settings randomized to Usual Care Arm. Participants who request their own eye doctor, the medical release form will be signed, and we will schedule the eye exam, so we can also track attendance.

  2 years

Secondary Outcomes (2)

• Return Attendance at Eye Health Screenings at 1, 2, and 3 Years

  1, 2, and 3 years

• Follow-up Adherence to Recommended In-office Eye Exams at 1 - 4 Years

  4 years

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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: Intervention

Usual Care

PLACEBO COMPARATOR

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.

Other: Usual Care

Interventions

Intervention OTHER

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.

Intervention Arm

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals age 40 years or older.
• Living independently.

You may not qualify if:

• Self-reported terminal illness with life expectancy of less than 1 year.
• Inability to provide informed consent due to dementia or other reason.

Sponsors & Collaborators

• Columbia University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Cuimc/Nyph

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Diabetic Retinopathy; Cataract; Refractive Errors; Vision Disorders; Blindness

Interventions

Methods

Condition Hierarchy (Ancestors)

Eye Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Lens Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Lisa A. Hark, PhD, MBA

  Columbia University Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa A. Hark, PhD, MBA

CONTACT

212-342-4586; lah112@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Ophthalmologists reading the fundus images will be masked to randomization assignment.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmic Sciences

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)