Vision Screening of the Four Year Old Children for the Detection of Amblyopia in The Town of Zagreb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7,000
- 试验地点
- 2
- 主要终点
- prevalence of amblyopia
研究概览
简要总结
INTRODUCTION. Amblyopia is defined as the loss of visual acuity (VA) in one or both eyes, without any obvious structural or pathological anomalies. Amblyopic eye should be able to regain some VA if treatment is initiated before the age of seven. It is the leading cause of monocular blindness in the 20- to 70-year olds with prevalence 2-5%. Amblyopia is mainly monocular, hence children are general asymptomatic. VA testing is the only reliable method of detecting amblyopia, and the fourth year of life is considered best for vision screening programs.
AIM: The purpose of the study is to reduce the preventable vision loss. The main goal of the study is to evidence the problem of amblyopia in Zagreb and to release a model for formal, government directed vision-screening program as a Croatian public health policy.
HYPOTHESIS. In Croatia, the prevalence and actual effect of amblyopia and amblyogenic factors, along with treatment efficacy is impossible to quantify, since no population-based studies have been performed regarding this issue. In addition, national screening of preschool children does not exist, while the school-entry screening is prescribed by law. The object of the study is to determine the prevalence of amblyopia in a 4-4.5 year old children of The Town of Zagreb, the efficacy of screening and effectiveness of treatment on reducing amblyopia prevalence. The primary hypothesis is defined: screening of visual acuity monocularly at distance and near in 4-4.5 year old children in Zagreb is effective in detecting amblyopia.
PATIENTS AND METHODS: Monocular vision of about 7000 children/ year aged 4-4.5 for whom both parents gave consent is to be tested with Lea chart at near (40cm) and distance (3m) in the kindergartens of The Town of Zagreb. The criterion for referral to complete ophthalmological examination is VA <0.8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 48 Months 至 54 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children in the kindergartens of The Town of Zagreb aged 4-4.5 for whom both parents gave written informed consent
排除标准
- •children younger than 4 years and children older than 4.5 years
研究组 & 干预措施
Amblyopia screening
干预措施: Amblyopia screening (Other)
结局指标
主要结局
prevalence of amblyopia
时间窗: 3 years
proportion of children with amblyopia in a total population of children screened
次要结局
未报告次要终点
研究者
Mladen Busic
Asst. prof., M.D., PhD
General Hospital Sveti Duh
