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

Columbia University

Status: Active, not recruiting

Conditions: Vision Impairment and Blindness; Cataract; Glaucoma; Eye Diseases; Diabetic Retinopathy

Treatments: Other: Usual Care; Behavioral: Enhanced Intervention Using Patient Navigators

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04271709

U01DP006436 (U.S. NIH Grant/Contract)

AAAR9162

Details and patient eligibility

About

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.

Full 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.

Enrollment: 749 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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749 participants in 2 patient groups, including a placebo group

Enhanced Intervention

Active Comparator group

Description:

Consented subjects living in buildings randomized to the Patient Navigator Intervention arm who failed the screening and needed vision correction received free eyeglasses, which were fitted by an optician at the housing building. If they were referred to an ophthalmologist for a follow-up eye exam, they received enhanced support with patient navigators to assist with follow-up eye exams at Columbia Ophthalmology or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.

Treatment:

Behavioral: Enhanced Intervention Using Patient Navigators

Usual Care

Placebo Comparator group

Description:

Consented subjects living in buildings randomized to Usual Care arm 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 who are referred to an ophthalmologist for a follow-up eye exam were only scheduled for their initial appointment at either Columbia Ophthalmology or Harlem Hospital. They did not receive enhanced support. Scheduling this initial appointment allowed tracking of adherence.

Treatment:

Other: Usual Care