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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Enhanced Intervention Using Patient Navigators
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced Intervention<br>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. | Behavioral: Enhanced Intervention Using Patient Navigators<br>* Enhanced support includes 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.<br>|
| Placebo Comparator: Usual Care<br>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. | Other: Usual Care<br>* Usual Care subjects 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vision Screening, Follow-up Eye Care, Vulnerable Populations, New York City