Clinical trial NCT05992415: New York City Eye Study (NYCES)
Official title: New York City Eye Study (NYCES)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glaucoma
Vision Impairment and Blindness
Cataract
Diabetic Retinopathy
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 10000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed innovative clinical trial will be a hybrid 2, masked, 2:1 cluster-randomized design (by housing development) comprised of adults age 21+ of diverse race/ethnicity (primarily African American and Hispanic/Latino) with high rates of inadequate eye care.
Primary purpose: OTHER

Brief summary: Dr. Lisa A. Hark (PI and Study Chair) and an interdisciplinary team have designed the New York City Eye Study (NYCES) to promote eye and vision health by conducting eye health screenings in adults age 21+ (PAR-23-009/NOT-EY-22-004).

Detailed description: The proposed innovative clinical trial will be a hybrid 2, masked, 2:1 cluster-randomized design (by housing development) comprised of adults age 21+ of diverse race/ethnicity (primarily African American and Hispanic/Latino) with high rates of inadequate eye care.(Curran 2012) A total of 14 NYCHA developments confirm access to 43,273 residents living at or below the NYC.gov poverty measure.(NYC Mayor Clinical measures (visual acuity, intraocular pressure, and fundus images), and quality-of-life will be assessed. To ensure that all community members receive the basic level of service, all participants who fail the eye health screening will be seen the same day by the study optometrist and eye glasses will be provided at no charge. All participant referred to ophthalmology will be assisted with scheduling their initial in-office eye exam appointment. Participants referred in the 9 developments randomized to the Intervention Arm will receive ongoing support from a patient navigator to assist with follow-up eye care; those referred in the 5 developments randomized to the Usual Care Arm + Automated Reminders, but will not receive support from patient navigators. The aims of the study are:

Aim 1) Using a type 2 hybrid design, evaluate the Effectiveness of a community-based intervention that begins with eye health screenings conducted at NYCHA affordable housing developments, followed by a 2:1 cluster-randomized clinical trial using Patient Navigators to increase: (a) Adherence to in-office eye exams for those referred to ophthalmology (Implementation outcome) and (b) Detection of eye disease(s) (glaucoma, retina, other) confirmed by the in-office eye exams (Clinical effectiveness outcome).

Aim 2: Assess Reach, Adoption, and Implementation using a mixed-methods study for those screened and referred to ophthalmology. Hypothesis: Assessing implementation outcomes and comparing among developments using a type 2 hybrid design will inform future intervention implementation.

Aim 3: Focusing on the Maintenance portion of RE-AIM, determine the costs and cost-effectiveness of eye health screenings and intervention, defined as cost per case detected, cost per participant achieving adherence, and sustainability at 1-4 years.

Impact: This community-based intervention addresses vision and eye health disparities by providing a basic level of services to all participants and addresses a structural issue of access to eye care by partnering with NYCHA. The evidence generated from this RCT has the potential to provide a roadmap for policy change.

Eligibility criteria: Inclusion Criteria:

* Individuals age 21 and older.
* Living independently in an affordable housing development and surrounding neighborhoods.

Exclusion Criteria:

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

Primary outcomes:
measure: Adherence to Follow-up Eye Care
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center - 622 W. 168th St. Floor 18
state: New York
Study officials:
affiliation: Columbia University Department of Ophthalmology
name: Lisa A. Hark
role: PRINCIPAL_INVESTIGATOR
References: