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Active, Not Recruiting

NCT Number: NCT04271709

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Glaucoma Blindness Cardiovascular Diseases Cataract Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Lens Diseases Nervous System Diseases Neurologic Manifestations Ocular Hypertension Pathological Conditions, Signs and Symptoms Retinal Diseases Sensation Disorders Signs and Symptoms Vascular Diseases Vision Disorders Vision Impairment and Blindness

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Intervention Using Patient Navigators

Behavioral

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

Usual Care

Other

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.

Primary outcomes

  1. Proportion of Subjects with Visual Acuity Worse than 20/40

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Feb 17, 2020
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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