New York City Eye Study (NYCES)

Cataract Clinical Trial

— NYCES  

Official title:

New York City Eye Study (NYCES)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05992415
• Other study ID #: AAAU8104
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2029

Study information

• Verified date: August 2023
• Source: Columbia University
• Contact: Lisa A. Hark, PhD, MBA
• Phone: 212-342-4586
• Email: lah112[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 equity and address eye health disparities in adults age 21+ (PAR-23-009/NOT-EY-22-004).

Description:

The proposed innovative clinical trial will be a hybrid 1, 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), quality-of-life, and falls risk 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 will not receive support from patient navigators. Participants referred to ophthalmology will be followed prospectively for 2 years to evaluate the effectiveness of the intervention on adherence to in-office follow-up eye care (primary outcome), presenting visual acuity and vision-related quality-of-life (secondary outcomes). We will also assess implementation outcomes including acceptability, fidelity, barriers and facilitators with the eye health screenings and optometrist eye exams. The aims of the study are:

Aim 1) Evaluate the effectiveness of a community-based intervention that begins with eye health screenings conducted in NYCHA affordable housing developments, followed by a hybrid 1 masked, cluster-randomized clinical trial using patient navigators to improve adherence to follow-up eye care.

Aim 2) Assess implementation outcomes of the intervention including reach, adoption, implementation, maintenance, and health equity (RE-AIM) using mixed methodology for those screened and referred to ophthalmology.

Aim 3) To determine the costs of the eye health screening and intervention and its cost effectiveness as cost per case detected and cost per participant achieving adherence as well as the intervention's health and social benefits to a densely urban community.

Impact: This community-based intervention provides basic level of services to everyone and is specifically addressing a structural issue of access to healthcare by partnering with NYCHA. The study will address vision and eye health disparities by testing the effectiveness of patient navigators to improve follow-up adherence in those who need follow-up eye care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blindness
• Cataract
• Diabetic Retinopathy
• Glaucoma
• Vision Impairment and Blindness

Intervention

Other:
• Intervention Using Patient Navigators
Consented participants referred to ophthalmology from the 9 developments randomized to the Intervention Arm will receive ongoing support from patient navigators to assist with all aspects of follow-up eye care and ocular surgery at either Harkness Eye Institute or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.
• Usual Care Without Patient Navigators
Consented participants referred from the 5 developments randomized to the Usual Care Arm 2 who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Harkness Eye Institute or Harlem Hospital. They will not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence. Arm 2 represents a realistic choice available for participants following screening over a 1-year period.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center - 622 W. 168th St. Floor 18	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Follow-up Eye Care	The Outcome Measure is ADHERENCE TO FOLLOW-UP EYE EXAM APPOINTMENT, and will be measured by appointment attendance at the initial eye exam appointment. The unit of measure is the eye exam appointment, which will be scheduled within 6-months of the referral at either Harkness Eye Institute or Harlem Hospital. The measure will assess the rate of adherence at the initial appointment. Comparison will be made between the 9 developments randomized to the Intervention Arm compared to 5 developments randomized to the Usual Care Arm.	1-year