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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04271709
Enrollment
749
Registered
2020-02-17
Start date
2019-09-30
Completion date
2026-09-29
Last updated
2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Diabetic Retinopathy, Eye Diseases, Glaucoma, Vision Impairment and Blindness

Keywords

Vision Screening, Follow-up Eye Care, Vulnerable Populations, New York City

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALEnhanced Intervention Using Patient Navigators

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

OTHERUsual Care

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.

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

2:1 randomization by housing development

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Subjects with Visual Acuity Worse than 20/402 yearsVisual 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026