The Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 749
- 试验地点
- 1
- 主要终点
- Proportion of Subjects with Visual Acuity Worse than 20/40
研究概览
简要总结
The investigators are conducting a 5-year prospective, 2:1 cluster-randomized controlled trial, funded by the Centers for Disease Control (CDC), which provides vision screenings to underserved New York City residents living in affordable housing buildings in Harlem and Washington Heights.
详细描述
This study aims to increase engagement, detection and management of glaucoma, vision impairment, cataracts, and other eye diseases in vulnerable populations living in New York City. This study considers disparities by race, ethnicity, gender, geography, and socioeconomic status using innovative approaches such as patient navigators. Individuals over the age of 40 living in New York City Housing Authority (NYCHA) Housing buildings are eligible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals over age 40
- •Living independently in NYCHA housing building or attending DFTA Senior Center
- •Willing to answer COVID-19 symptom questions
- •Willing to consent for 2 vision screening visits at baseline and 12-month follow-up
排除标准
- •Self-reported terminal illness with life expectancy less than 1 year
- •Inability to provide informed consent due to dementia or other reasons
研究组 & 干预措施
Enhanced Intervention
Consented subjects living in buildings randomized to the Patient Navigator Intervention arm who failed the screening and needed vision correction received free eyeglasses, which were fitted by an optician at the housing building. If they were referred to an ophthalmologist for a follow-up eye exam, they received enhanced support with patient navigators to assist with follow-up eye exams at Columbia Ophthalmology or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.
干预措施: Enhanced Intervention Using Patient Navigators (Behavioral)
Usual Care
Consented subjects living in buildings randomized to Usual Care arm who failed the screening and needed vision correction were given an eyeglasses prescription and a list of optical shops within 1 mile from their home. These subjects who are referred to an ophthalmologist for a follow-up eye exam were only scheduled for their initial appointment at either Columbia Ophthalmology or Harlem Hospital. They did not receive enhanced support. Scheduling this initial appointment allowed tracking of adherence.
干预措施: Usual Care (Other)
结局指标
主要结局
Proportion of Subjects with Visual Acuity Worse than 20/40
时间窗: 2 years
Visual acuity (VA) is a measure of the spatial resolution of the visual processing system. Visual acuity will be measured in each eye and measured as ≤20/40 or \>20/40. Since there are two best corrected distance visual acuity measurements per person (right eye and left eye), the visual acuity in the worse eye will be used in the analysis and reported at the patient level, rather than the eye level. Visual acuity analysis will be handled as a dichotomous variable and the proportion of subjects with visual acuity 20/40 or worse will be considered abnormal.
次要结局
未报告次要终点
研究者
Lisa Hark, PhD, MBA
Professor of Ophthalmic Sciences
Columbia University