The Efficacy of a Visual Screening Program to Reduce Later Amblyopia and Untreated Refractive Errors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,597
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
Screened Schools
25 schools. Screening involved: crowded HOTV acuity test, Preschool Randot Stereoacuity Test, and Plusoptix autorefractor. Referral criteria followed AAPOS guidelines for screening for amblyopia and amblyopia risk factors. Children who fail any one of the three tests (including uncooperative/unable children) will be given a referral letter, which includes an assigned appointment time for a comprehensive eye exam at school with a licensed optometrist. Any needed glasses will be dispensed at no cost to the parents. 6 months after the eye exam, we will follow up with a phone call to parents to offer any additional support (such as replacing broken/lost glasses)
干预措施: Crowded HOTV Acuity Test (Other)
Screened Schools
25 schools. Screening involved: crowded HOTV acuity test, Preschool Randot Stereoacuity Test, and Plusoptix autorefractor. Referral criteria followed AAPOS guidelines for screening for amblyopia and amblyopia risk factors. Children who fail any one of the three tests (including uncooperative/unable children) will be given a referral letter, which includes an assigned appointment time for a comprehensive eye exam at school with a licensed optometrist. Any needed glasses will be dispensed at no cost to the parents. 6 months after the eye exam, we will follow up with a phone call to parents to offer any additional support (such as replacing broken/lost glasses)
干预措施: Preschool Randot Stereoacuity Test (Other)
Screened Schools
25 schools. Screening involved: crowded HOTV acuity test, Preschool Randot Stereoacuity Test, and Plusoptix autorefractor. Referral criteria followed AAPOS guidelines for screening for amblyopia and amblyopia risk factors. Children who fail any one of the three tests (including uncooperative/unable children) will be given a referral letter, which includes an assigned appointment time for a comprehensive eye exam at school with a licensed optometrist. Any needed glasses will be dispensed at no cost to the parents. 6 months after the eye exam, we will follow up with a phone call to parents to offer any additional support (such as replacing broken/lost glasses)
干预措施: Plusoptix Autorefractor (Device)
Care As Usual Schools
25 schools were randomly allocated to the "care as usual" schools. No intervention was provided by the research team, however, children may have received optometry/ophthalmology care via regular referral channels (e.g., family physicians, teachers)
Screened Schools
25 schools. Screening involved: crowded HOTV acuity test, Preschool Randot Stereoacuity Test, and Plusoptix autorefractor. Referral criteria followed AAPOS guidelines for screening for amblyopia and amblyopia risk factors. Children who fail any one of the three tests (including uncooperative/unable children) will be given a referral letter, which includes an assigned appointment time for a comprehensive eye exam at school with a licensed optometrist. Any needed glasses will be dispensed at no cost to the parents. 6 months after the eye exam, we will follow up with a phone call to parents to offer any additional support (such as replacing broken/lost glasses)
干预措施: Comprehensive Eye Exam (Other)
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
Agnes Wong
Senior Scientist; Neurosciences and Mental Health
The Hospital for Sick Children