Village-Integrated Eye Worker Trial II - Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87,992
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
The vast majority of blindness is avoidable. The World Health Organization (WHO) estimates that 80% of cases of visual impairment could be prevented or reversed with early diagnosis and treatment. The leading causes of visual impairment are cataract and refractive error, followed by glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy (DR). Loss of vision from these conditions is not inevitable; however, identifying at-risk cases and linking cases with appropriate care remain significant challenges.
Eye health care systems must determine optimal strategies for reaching people outside of their immediate orbit in order to reduce visual impairment. Visual impairment can be reduced by case detection of prevalent disease like cataract and refractive error, or by screening for early disease like glaucoma, AMD, and DR and preventing progression. Systems around the world have developed numerous approaches to both case detection and screening but there is very little research to support the choice of allocating resources to case detection or screening and little data exists on the cost effectiveness of the various approaches to each.
VIEW II Pilot is a cluster-randomized trial to determine the effectiveness of different approaches to community-based case detection and screening for ocular disease. Communities will be randomized to one of four arms: 1) a comprehensive ocular screening program, 2) a cataract camp-based program, 3) a community health worker-based program, and 4) no program.
详细描述
Specific Aim 1: to determine whether screening leads to increased visual acuity compared to the cataract camp approach.
Specific Aim 2: to determine whether a community health volunteer program increases the rate of cataract surgery compared to a no program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(community-level):
- •Wards in the Chitwan and Nawalparasi districts that participated in the VIEW trial and have not received a cataract camp in the past 6 months.
- •Inclusion Criteria (individual-level):
- •Individuals aged 50 and older will be eligible to participate in the screening program, cataract camp programs, and the FCHV program
排除标准
- 未提供
研究组 & 干预措施
No intervention
Community-based screening
干预措施: Community-based screening program (Other)
Cataract camp program
干预措施: Cataract camp program (Other)
Community health worker program
干预措施: Community health worker program (Other)
结局指标
主要结局
Visual acuity
时间窗: 1 year
Primary outcome for specific aim 1, comparison between screening and case detection arms
Cataract surgical rate
时间窗: 1 year
Primary outcome for specific aim 2, comparison between community health worker program and no program arms
次要结局
- Cost-effectiveness(1 year)
- Visual acuity(1 year)
- Number of cases of ocular disease detected(1 year)