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

5840 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Individuals living in Upper Manhattan have limited access to eye care, high vision impairment rates, and poor ocular health outcomes. To improve eye care and vision health outcomes, the Eye Health Intervention Study in Upper Manhattan (EYES-UM) will conduct eye health screenings in accessible primary care health centers and senior centers and implement a behavioral intervention to improve adherence for those referred for in-office eye care. The proposed innovative, 2:1 cluster-randomized clinical trial, will recruit adults age 40 and older in Upper Manhattan with known rates of inadequate eye care. A total of 10 settings in Upper Manhattan, comprised of primary care offices, senior centers, and organizations, confirms access to 17,000 individuals living at or below the NYC.gov poverty measure. This study will conduct ocular tests (visual acuity, intraocular pressure, fundus images) during screenings. To ensure that all participants receive the basic level of service, all participants who fail the eye health screening will be seen the same day by a study optometrist and eyeglasses will be provided at no charge. Educational workshops and an Advisory Board will support recruitment. Intervention Arm participants will receive ongoing support with scheduling eye exams and transportation by trained Study Coordinators. All participants will be followed prospectively for 2 years. The study is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework. Conducting Focus Groups with health policy stakeholders ensures iterative input during the study to bridge and translate EYES-UM findings into a Vision Health Policy Roadmap for scalable implementation of vision care delivery models, focusing on adherence.

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.

How does the System-Level Intervention treatment for visual impairment differ from other treatments?

The System-Level Intervention for visual impairment is unique because it focuses on a comprehensive approach that may include various components like rehabilitation programs, training in low vision devices, and possibly other supportive measures, rather than just addressing the visual impairment itself. This holistic approach aims to improve overall functioning, participation, and quality of life, especially in children, which is not typically the focus of standard treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment System-Level Intervention for Visual Impairment?

The research on low vision rehabilitation (LVR) suggests that patient-centered measurements can reflect meaningful improvements in visual ability, indicating that tailored interventions can be effective for visual impairment. ^{1 6 7 8 9}

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. United States pubmed.ncbi.nlm.nih.gov

Comparison of clinician-predicted to measured low vision outcomes. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Chronic disease interventions for people with visual impairment: A systematic review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Development of a core outcome set for evaluative research into paediatric cerebral visual impairment (CVI), in the UK and Eire. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Rehabilitation needs and activity limitations of adults with a visual impairment entering a low vision rehabilitation service in England. [2019]

6. England pubmed.ncbi.nlm.nih.gov

VA LOVIT II: a protocol to compare low vision rehabilitation and basic low vision. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

How effective is low vision service provision? A systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Interventions to improve functioning, participation, and quality of life in children with visual impairment: a systematic review. [2019]

9. India pubmed.ncbi.nlm.nih.gov

Impact of low vision rehabilitation on functional vision performance of children with visual impairment. [2022]