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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am over 40 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,084 Total Patients Enrolled
2 Trials studying Diabetic Retinopathy
10,030 Patients Enrolled for Diabetic Retinopathy
Centers for Disease Control and PreventionFED
875 Previous Clinical Trials
22,476,653 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
5,473 Patients Enrolled for Diabetic Retinopathy
Lisa A. Hark, PhD, RDPrincipal InvestigatorColumbia University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 40 years old.You live on your own in a NYCHA housing building or regularly go to a DFTA Senior Center.You have self-reported that you have a terminal illness and are expected to live less than 1 year.I am unable to understand or sign the consent form due to cognitive issues.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Enhanced Intervention
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an open enrollment period for the experiment?
"According to clinicaltrials.gov, the search for patient volunteers is not taking place at present. The study was posted on September 30th 2019 and last updated November 4th 2022. However, there are presently 486 other medical trials that are open to recruitment of participants."
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