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临床试验/NCT02458846
NCT02458846已完成不适用

The Efficacy of a Visual Screening Program to Reduce Later Amblyopia and Untreated Refractive Errors

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 2,597 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,597
试验地点
2
主要终点
Prevalence of reduced stereo vision

研究概览

简要总结

Amblyopia (lazy eye), is the leading treatable cause of vision loss in childhood. Uncorrected refractive errors (ie farsightedness) can lead to difficulties in school. Unfortunately, many children do not receive vision screening until they have already developed irreversible vision problems. We will conduct a cluster randomized clinical trial in which schools, not individual children, are randomly allocated to receive a kindergarten visual screening program or to receive no intervention by the research team (i.e., "care as usual"). We will compare the prevalence of visual problems (and proportion of children with reading problems) when the children are in Grade 2, after allowing for at least one year of treatment.

详细描述

The proposed study is a single-masked cluster randomized clinical trial, with randomization and analyses occurring at the level of "schools" (i.e., we are not randomly assigning individuals to groups). To assess the efficacy of a visual screening program, we will compare visual outcomes in 25 schools randomly chosen to receive the program and 25 schools allocated to "care as usual" one year after screening. The screening tools are HOTV crowded acuity, Preschool Randot Stereoacuity Test, and Plusoptix Autorefractor. The outcome measures will assess later differences between schools receiving the visual screening program and control schools for prevalence of (1) visual and (2) reading problems. A lower prevalence of either or both problems in schools where the visual screening program was offered would provide evidence for the efficacy of vision screening. Primary outcome measure is the prevalence of amblyopia, reduced stereo vision, and untreated clinically significant refractive errors in "screened" versus "care as usual" schools. Secondary outcome measure is the proportion of children performing 1 standard deviation below average on reading scores in "screened" versus "care as usual" schools.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Screening: children enrolled in senior kindergarten (age 5-6 years)
  • Follow-up: children enrolled in Grade 2 (age 7-8 years)

排除标准

  • 未提供

结局指标

主要结局

Prevalence of reduced stereo vision

时间窗: 16 months

Stereoacuity is often reduced in patients with some types of amblyopia, and will defined as worse than 30 arcsec

Prevalence of refractive errors

时间窗: 16 months

Untreated clinically significant refractive errors defined by AAPOS (2013) guidelines

Prevalence of amblyopia

时间窗: 16 months

Prevalence of suspected amblyopia, defined as 2-or-greater line difference in acuity between eyes

次要结局

  • Proportion of below-average readers Year 1(10 months)
  • Proportion of below-average readers Year 2(22 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Agnes Wong

Senior Scientist; Neurosciences and Mental Health

The Hospital for Sick Children

研究点 (2)

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