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临床试验/NCT01430247
NCT01430247已完成不适用

Vision Screening of the Four Year Old Children for the Detection of Amblyopia in The Town of Zagreb

Mladen Busic2 个研究点 分布在 1 个国家目标入组 7,000 人开始时间: 2011年9月12日最近更新:
适应症
干预措施

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

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

Other

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

发起方
Mladen Busic
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mladen Busic

Asst. prof., M.D., PhD

General Hospital Sveti Duh

研究点 (2)

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