Vision Screening + Patient Navigation for Eye Diseases

Overseen By James Auran, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Terminal illness, Dementia, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve eye care for underserved residents in New York City by providing vision screenings and follow-up support. Participants will receive either usual care, which includes a prescription and a list of nearby optical shops, or an enhanced intervention using patient navigators. The enhanced intervention provides free glasses and assistance with scheduling and transportation for eye exams. The trial targets individuals over 40 living in specific affordable housing or senior centers in Harlem and Washington Heights who are open to having their vision checked twice over a year. This research seeks to find better ways to manage eye health in communities that often lack access to these services. As an unphased trial, it offers a unique opportunity to contribute to improving community eye health services.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this vision screening and patient navigation protocol is safe?

Research has shown that patient navigators in vision care can help people keep their eye exam appointments, which is important for better eye health. However, studies have not provided specific safety details about using patient navigators in these programs.

Patient navigators mainly assist with scheduling and transportation, and they don't usually provide medical treatment, making it a low-risk approach. Since the CDC funds the study and aims to improve current care with extra support, it is likely safe.

The program has demonstrated effectiveness and may help reduce obstacles to obtaining eye care in underserved communities. The main goal is to improve access and follow-up, so any safety concerns are minimal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing eye health through enhanced patient support. Unlike the typical method where patients are given a prescription and a list of optical shops, the enhanced intervention provides free eyeglasses and personalized assistance from patient navigators. These navigators help schedule follow-up eye exams and arrange transportation, making it easier for patients to adhere to their eye care plan. This comprehensive support system could potentially improve access to and consistency of eye care, leading to better outcomes for individuals with vision issues.

What evidence suggests that this trial's treatments could be effective for eye diseases?

This trial will compare two approaches: Usual Care and an Enhanced Intervention using Patient Navigators. Research has shown that patient navigators, as in the Enhanced Intervention arm of this trial, can help people attend their eye exams more regularly. One study found that these navigators assisted individuals in keeping their eye doctor appointments after being checked for eye issues. This method proves especially effective in communities with limited access to eye care. The improved support includes reminders and help with transportation, making it easier for people to attend their appointments. Early results suggest that this assistance could lead to better eye care and early detection of eye problems. ^{1 2 3 5 6}

Who Is on the Research Team?

Lisa A. Hark, PhD, RD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am over 40 years old.

Willing to answer COVID-19 symptom questions

Willing to consent for 2 vision screening visits at baseline and 12-month follow-up

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vision Screening

Vision screenings are provided to underserved New York City residents living in affordable housing buildings

5 years

Multiple visits as needed

Follow-up

Participants are monitored for adherence to follow-up eye exams and vision correction

1 year

Follow-up visits scheduled as needed

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Intervention Using Patient Navigators
• Usual Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Enhanced Intervention Active Control 1 Intervention

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.

Group II: Usual Care Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11650758/

Manhattan Vision Screening and Follow-up Study in ... Outcomes: We plan to follow participants prospectively to evaluate the effects of an enhanced intervention using patient navigators on presenting visual acuity ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002939425000984

Patient Navigators Improve In-Office Eye Exam Adherence ... Patient navigators improved adherence to in-office eye exams following community-based eye health screenings and referral to ophthalmology among an underserved ...

3. withpower.com withpower.com/trial/phase-blindness-8-2019-f0b41

Vision Screening + Patient Navigation for Eye Diseases What data supports the effectiveness of the treatment Enhanced Intervention Using Patient Navigators for eye diseases? The research on diabetic retinopathy ...

4. clinicaltrials.gov clinicaltrials.gov/show/NCT04271709

Manhattan Vision Screening and Follow-Up Study (NYC ... This study aims to increase engagement, detection and management of glaucoma, vision impairment, cataracts, and other eye diseases in vulnerable populations ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40015588/

Patient Navigators Improve In-Office Eye Exam Adherence ... Conclusions: Patient navigators improved adherence to in-office eye exams following community-based eye health screenings and referral to ...

6. stacks.cdc.gov stacks.cdc.gov/view/cdc/175436/cdc_175436_DS1.pdf

Manhattan Vision Screening and Follow-Up Study in ... Conclusion: This study demonstrates the feasibility of using CHWs and patient navigators for reducing barriers to vision screening and ...