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

Not Applicable

Active, not recruiting

• Conditions: Eye Diseases; Diabetic Retinopathy; Glaucoma; Cataract; Vision Impairment and Blindness
• Interventions: Other: Usual Care; Behavioral: Enhanced Intervention Using Patient Navigators

• Registration Number: NCT04271709
• Lead Sponsor: Columbia University

Brief Summary

The investigators are conducting a 5-year prospective, cluster-randomized controlled trial, funded by the Centers for Disease Control (CDC), which provides vision screenings to underserved, vulnerable 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-09-30
• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-09-29
• Study Completion: 2025-09-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 749

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Consented subjects living in buildings randomized to Usual Care arm who fail the screening and need vision correction will be given an eyeglasses prescription and a list of optical shops within 1 mile from their home. These subjects who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Harkness Eye Institute or Harlem Hospital. They will not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence.
Enhanced Intervention	Enhanced Intervention Using Patient Navigators	Consented subjects living in buildings randomized to the Enhanced Intervention arm who fail the screening and need vision correction will receive free eyeglasses, which will be fitted by an optician at the housing building. If they are referred to an ophthalmologist for a follow-up eye exam, they will receive enhanced support with patient navigators to assist with all aspects of follow-up eye care and ocular surgery at either Harkness Eye Institute or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects with Visual Acuity Worse than 20/40	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.

Trial Locations

Locations (1)

Columbia University; 🇺🇸 New York, New York, United States