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EYES-UMEye Health Intervention Study in Upper Manhattan

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What is being tested

Intervention

+ Usual Care

Other
Who is being recruted

Blindness+17

+ Cardiovascular Diseases

+ Cataract

Over 40 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Screening Study

Placebo-Controlled
Interventional
Study Start: April 2026
See protocol details

Summary

Principal SponsorColumbia University
Study ContactLisa A. Hark, PhD, MBA
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2026

Actual date on which the first participant was enrolled.

The Eye Health Intervention Study in Upper Manhattan aims to improve access to eye care for adults aged 40 and older living in this urban area. Many people in Upper Manhattan face challenges in getting proper eye care, leading to high rates of vision problems and poor eye health. By bringing eye health screenings directly to community settings like health and senior centers, the study seeks to make eye care more accessible. The ultimate goal is to provide a model that could be expanded to other areas, offering a practical solution to improve vision health and reduce eye disease. Participants in this study will first receive eye health screenings, which include tests for visual acuity, eye pressure, and retinal images. Those who need further care will see an optometrist the same day and receive free eyeglasses if necessary. Participants in the intervention group will also get help with scheduling follow-up eye exams and transportation. The study tracks participants for two years to see if these supports help them stick to recommended eye care visits and detect eye diseases earlier. This approach also involves educational workshops and community feedback to ensure the program's success and adaptability for broader use.

Official TitleEye Health Intervention Study in Upper Manhattan
NCT06112431
Principal SponsorColumbia University
Study ContactLisa A. Hark, PhD, MBA
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5840 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BlindnessCardiovascular DiseasesCataractDiabetes MellitusDiabetic AngiopathiesDiabetic RetinopathyEndocrine System DiseasesEye DiseasesLens DiseasesNervous System DiseasesNeurologic ManifestationsOcular HypertensionRefractive ErrorsRetinal DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesVision DisordersDiabetes Complications

Criteria

2 inclusion criteria required to participate
Individuals age 40 years or older.
Living independently.
2 exclusion criteria prevent from participating
Self-reported terminal illness with life expectancy of less than 1 year.
Inability to provide informed consent due to dementia or other reason.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Cuimc/Nyph

New York, United StatesOpen Cuimc/Nyph in Google Maps
Recruiting soonOne Study Center
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