Manhattan Vision Screening and Follow-Up Study

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04271709

Collaborator

Centers for Disease Control and Prevention (U.S. Fed)

2,373

Enrollment

Location

Arms

59.1

Anticipated Duration (Months)

40.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Vision Impairment and Blindness Cataract Diabetic Retinopathy Eye Diseases	Behavioral: Enhanced Intervention Using Patient Navigators Other: Usual Care	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2373 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

The Manhattan Vision Screening and Follow-Up Study in Vulnerable Populations

Actual Study Start Date :

Sep 30, 2019

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Enhanced Intervention 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 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.
Placebo Comparator: 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.	Other: Usual Care 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.

Arm

Intervention/Treatment

Active Comparator: Enhanced Intervention

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

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.

Placebo Comparator: 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.

Other: Usual Care

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Individuals over age 40
Living independently in NYCHA housing building.
Willing to answer COVID-19 symptom questions
Willing to consent for 2 vision screening visits at baseline and 12-month follow-up