System-Level Intervention for Visual Impairment

(EYES-UM Trial)

Overseen By Lisa A. Hark, PhD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Terminal illness, Dementia, others

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance eye care and vision health for adults in Upper Manhattan through a System-Level Intervention. It provides free eye health screenings at local centers, including checks for vision clarity and eye pressure. Participants needing further eye care will receive assistance with scheduling and transportation to appointments. The trial seeks individuals aged 40 and older who live independently in Upper Manhattan and may lack regular access to eye care. As an unphased trial, it presents a unique opportunity to access free eye care services and contribute to community health improvements.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on eye health screenings and support, so it's unlikely that you would need to change your medications.

What prior data suggests that this system-level intervention is safe for improving eye care access?

Research on eye care systems highlights several safety considerations. One study analyzing patient safety incidents in eye care found that most issues related to clinical care, but it did not specify the details of these incidents. This indicates some risks exist, but the seriousness and frequency remain unclear.

The World Health Organization's report on vision emphasizes the need for eye care that is both safe and accessible. However, it does not provide specific safety data for the treatments themselves.

The study is labeled "Not Applicable" regarding its phase, suggesting it might be in the early stages. In such cases, while direct safety evidence may be limited, the interventions are likely designed to be low-risk, focusing on system improvements rather than new medical treatments. Overall, despite the lack of detailed safety data, the intervention is expected to be well-tolerated, primarily aiming to improve access to and adherence to eye care. ^{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 visual impairment by providing a system-level intervention. Unlike the usual care, which includes basic eye health services and an initial in-office eye exam, this intervention offers hands-on assistance with scheduling and transportation for eye appointments over two years. This added support aims to improve access to eye care and potentially lead to better outcomes for individuals with visual impairment. By addressing logistical barriers to eye care, researchers hope to find out if this approach significantly enhances patient adherence and overall eye health compared to standard options.

What evidence suggests that this trial's system-level intervention could be effective for improving eye care and vision health outcomes?

Research shows that community programs can effectively identify individuals with vision problems and eye diseases. Studies have found that these conditions are often detected when eye care integrates into local health services. Additionally, providing basic eye care at community health centers has improved overall health related to vision issues. Simple low vision rehabilitation can also reduce disabilities and enhance the quality of life for those with vision problems. This trial will compare a community-focused approach, where participants in the Intervention Arm receive additional support with scheduling and transportation for eye care appointments, to Usual Care, which offers basic eye health services without additional support. This suggests that the community-focused approach under study could improve eye care and outcomes in areas that need it most. ^{6 7 8 9 10}

Who Is on the Research Team?

Lisa A. Hark, PhD, MBA

Principal Investigator

Columbia University Department of Ophthalmology

Are You a Good Fit for This Trial?

This trial is for adults aged 40+ living in Upper Manhattan, who visit community health settings at least once a year and live independently. It aims to help those with eye conditions like glaucoma, cataracts, or diabetic retinopathy by providing screenings and follow-up care.

Inclusion Criteria

I am 40 years old or older.

I live on my own without needing daily help.

Exclusion Criteria

Self-reported terminal illness with life expectancy of less than 1 year

I am unable to understand and give consent for treatment due to dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Not specified

1 visit (in-person)

Intervention

Participants in the Intervention Arm receive assistance with scheduling eye exams and transportation over 2 years

2 years

Usual Care

Participants receive basic eye health screening, optometric exam if needed, and eyeglasses at no charge

2 years

Follow-up

Participants are monitored for adherence to recommended in-office eye exams and detection of eye disease

4 years

What Are the Treatments Tested in This Trial?

Interventions

• System-Level Intervention
• Usual Care

Trial Overview The study tests a System-Level Intervention against Usual Care to improve vision health. Participants will receive eye screenings; if issues are found, they'll get same-day optometrist visits and free glasses. The intervention group also gets help scheduling exams and transportation.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Participants randomized to the Intervention Arm and referred to ophthalmology will receive assistance from a Study Coordinator with scheduling in-office eye exam appointment and arranging transportation to these appointments over 2 years at either Columbia Ophthalmology, Harlem Hospital, or their own eye care provider.

Group II: Usual Care Placebo Group 1 Intervention

Consented participants randomized to the Usual Care Arm will receive all the basic level of services including the eye health screening, optometric exam if they fail the screening, and eyeglasses at no charge. Those who require referral to ophthalmology will be scheduled for the initial in-office eye exam and their outcomes will be tracked. No additional support will be provided the Usual Care participants during the study. The Usual Care Arm represents a realistic choice currently available for participants following eye health screening.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Published Research Related to This Trial

A study involving 316 low-vision patients and 38 clinicians found that clinicians' predictions of the success of low-vision rehabilitation (LVR) did not correlate with the actual self-reported outcomes of patients, indicating a disconnect between clinician expectations and patient experiences.

Clinicians' predictions were influenced by patients' cognitive functioning and a combination of visual acuity and functional ability, but these predictions were not reliable, as they showed no better agreement with patient outcomes than chance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of clinician-predicted to measured low vision outcomes. Chan, TL., Goldstein, JE., Massof, RW.[2021]

In a study of 779 patients undergoing low vision rehabilitation (LVR) across 28 clinical centers, nearly half (47%) showed clinically meaningful improvements in overall visual ability after 6 to 9 months of rehabilitation.

The largest effect size was observed in overall visual ability (Cohen d = 0.87), indicating significant benefits from LVR, with age and visual acuity being important predictors of improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers. Goldstein, JE., Jackson, ML., Fox, SM., et al.[2020]

The LOVIT II trial is a multicenter randomized controlled trial involving 330 patients with macular disease, aiming to compare the effectiveness of low vision rehabilitation (LVR) with basic low vision (LV) services.

Preliminary results show that LVR, which includes therapy sessions to teach effective use of vision aids, may lead to better improvements in visual reading ability compared to basic LV, where devices are simply dispensed without additional training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VA LOVIT II: a protocol to compare low vision rehabilitation and basic low vision. Stelmack, JA., Tang, XC., Reda, DJ., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12397583/

The Case for Primary Eye Care Integration in Community ... In doing so, eye care in CHCs positively influences broader health outcomes associated with vision impairment. Visually impaired individuals ...

2. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-23112-5

Community-based interventions to detect visual impairment in ... Results across studies indicated that CBIs can detect individuals with VI and/or eye disease, with ten studies reporting high rates of ...

3. who.int who.int/publications/i/item/9789240058002

Report of the 2030 targets on effective coverage of eye care This report draws on key results from a comprehensive analysis of population-based eye health surveys and includes estimates of effective cataract surgery ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0039625724000225

Clinical outcome measures in vision and eye care In this review we introduce a framework by which clinical outcome assessments (COAs) can be organized. Our COA framework is composed of five outcome ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9651903/

The Basic VRS-Effect Study: Clinical Trial Outcomes and ... The current study confirmed that a basic low vision rehabilitation intervention reduces disabilities and improves quality of life in people with impaired vision ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12089528/

Patient safety in eye care: a multi-method analysis of reported ... We aimed to characterise patient safety incidents involving eye care by: identifying the most frequently reported incidents involving clinical care;

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10829826/

A Literature Review of the Impact of Place on Vision ... In this narrative literature review, we assess the relationship between neighborhood and built environment SRFs and eye health and vision outcomes.

8. thelancet.com thelancet.com/journals/langlo/article/PIIS2214-109X(21)00303-X/fulltext

Vision impairment and traffic safety outcomes in low- ... The summary estimate revealed a 46% increased risk of road traffic crash among those with visual impairment (RR 1·46 [95% CI 1·20–1·78], test ...

9. reviewofoptometry.com reviewofoptometry.com/news/article/social-inequity-associated-with-poor-visual-outcomes

Social Inequity Associated With Poor Visual Outcomes The research shows an increased odds of vision difficulty and blindness after controlling for census tract-level median age, the percentage of ...

10. who.int who.int/docs/default-source/documents/publications/world-vision-report-accessible.pdf

World report on vision The World report on vision sets out concrete proposals to address challenges in eye care. The key proposal is to make integrated people- centred eye care, ...