System-Level Intervention for Visual Impairment
(EYES-UM Trial)
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants in the Intervention Arm receive assistance with scheduling eye exams and transportation over 2 years
Usual Care
Participants receive basic eye health screening, optometric exam if needed, and eyeglasses at no charge
Follow-up
Participants are monitored for adherence to recommended in-office eye exams and detection of eye disease
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?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
National Eye Institute (NEI)
Collaborator
Published Research Related to This Trial
Citations
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/s12889-025-23112-5Community-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 ...
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 ...
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 ...
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 ...
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;
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.
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-outcomesSocial 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 ...
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, ...
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