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NCT06112431Withdrawn

Eye Health Intervention Study in Upper Manhattan

Source: ClinicalTrials.gov · Last updated 29 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Withdrawn
Study type
Interventional
Enrollment
0 (actual)
First submitted
26 Oct 2023
Start date
1 Apr 2027
Primary completion date
31 Mar 2031
Lead sponsor
Columbia University
NCT number
NCT06112431

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Self-reported terminal illness with life expectancy of less than 1 year.
  • Inability to provide informed consent due to dementia or other reason.

Who the study is looking for

  • Individuals age 40 years or older.
  • Living independently.

Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Cuimc/Nyph
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New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.