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Vision Screening + Patient Navigation for Eye Diseases

N/A

Waitlist Available

Led By Lisa A. Hark, PhD, RD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals over age 40

Be older than 18 years old

Must not have

Inability to provide informed consent due to dementia or other reasons

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Summary

This trial provides free vision screenings to residents of affordable housing buildings in Harlem and Washington Heights.

Who is the study for?

This trial is for people over 40 living independently in NYCHA housing or attending DFTA Senior Centers in Harlem and Washington Heights, willing to undergo two vision screenings. Those with terminal illness or unable to consent due to dementia cannot participate.

What is being tested?

The NYC-SIGHT study is testing if using patient navigators for follow-up improves eye health outcomes compared to usual care among underserved residents after a vision screening.

What are the potential side effects?

Since this trial involves non-invasive procedures like vision screenings and the use of patient navigators, there are no direct medical side effects associated with the interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand or sign the consent form due to cognitive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Subjects with Visual Acuity Worse than 20/40

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Enhanced InterventionActive Control1 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.

Group II: Usual CarePlacebo Group1 Intervention

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.

0 / 2Eligibility criteria met