Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)

N/AActive Not RecruitingNCT04271709

Columbia University749 enrolled

Overview

The investigators are conducting a 5-year prospective, 2:1 cluster-randomized controlled trial, funded by the Centers for Disease Control (CDC), which provides vision screenings to underserved New York City residents living in affordable housing buildings in Harlem and Washington Heights.

This study aims to increase engagement, detection and management of glaucoma, vision impairment, cataracts, and other eye diseases in vulnerable populations living in New York City. This study considers disparities by race, ethnicity, gender, geography, and socioeconomic status using innovative approaches such as patient navigators. Individuals over the age of 40 living in New York City Housing Authority (NYCHA) Housing buildings are eligible.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

749

Conditions

Glaucoma Vision Impairment and Blindness Cataract Diabetic Retinopathy Eye Diseases

Interventions

Enhanced Intervention Using Patient NavigatorsBEHAVIORAL

Enhanced support by patient navigators assisted with follow-up eye exam appointment scheduling and arranging transportation over a 1-year period.

Usual CareOTHER

Usual Care subjects who failed the screening and needed vision correction were given an eyeglasses prescription and a list of optical shops within 1 mile from their home. These subjects did not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence.

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals over age 40 * Living independently in NYCHA housing building or attending DFTA Senior Center * Willing to answer COVID-19 symptom questions * Willing to consent for 2 vision screening visits at baseline and 12-month follow-up Exclusion Criteria: * Self-reported terminal illness with life expectancy less than 1 year * Inability to provide informed consent due to dementia or other reasons

Locations (1)

Columbia University

New York, New York, United States

Outcomes

Primary Outcomes

Proportion of Subjects with Visual Acuity Worse than 20/40

Visual acuity (VA) is a measure of the spatial resolution of the visual processing system. Visual acuity will be measured in each eye and measured as ≤20/40 or \>20/40. Since there are two best corrected distance visual acuity measurements per person (right eye and left eye), the visual acuity in the worse eye will be used in the analysis and reported at the patient level, rather than the eye level. Visual acuity analysis will be handled as a dichotomous variable and the proportion of subjects with visual acuity 20/40 or worse will be considered abnormal.

Time frame: 2 years

Data from ClinicalTrials.gov

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