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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
Awards & highlights

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 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.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,471 Previous Clinical Trials
2,535,601 Total Patients Enrolled
2 Trials studying Diabetic Retinopathy
10,030 Patients Enrolled for Diabetic Retinopathy
Centers for Disease Control and PreventionFED
882 Previous Clinical Trials
22,474,236 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
5,473 Patients Enrolled for Diabetic Retinopathy
Lisa A. Hark, PhD, RDPrincipal InvestigatorColumbia University

Media Library

Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT04271709 — N/A
Diabetic Retinopathy Clinical Trial 2023: Usual Care Highlights & Side Effects. Trial Name: NCT04271709 — N/A
Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04271709 — N/A
Diabetic Retinopathy Research Study Groups: Usual Care, Enhanced Intervention
~0 spots leftby Sep 2024
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