跳至主要内容
临床试验/NCT03251456
NCT03251456已完成不适用

Tertiary Care Based Visual Developmental Diseases Management Model Among Preschool Children in China: a Cluster Randomized Controlled Trial

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 1,114 人开始时间: 2017年8月18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
入组人数
1,114
试验地点
1
主要终点
The consultation rate in six month after the parents receiving the visual screening report

研究概览

简要总结

Visual development disorders are major public health problems among children especially in China. How to find an effective and economic way to manage the larger number of children in China remains exploring. The national basic public health services of China offer visual acuity screening for preschool children for free every year. The aim of this study is to demonstrate the feasibility, cost-effective and the influence factors of compliance of tertiary care for visual developmental disorders in pre-school children after screening, and whether this disease management model is more effective and superior than the current medical care in china.

详细描述

Visual development disorders including amblyopia , strabismus ,refractive error are an important public health problem among children, and the visual impairment caused by visual development disorders is lifelong and can be profound. Timely discovering and treatment of visual development disorders are significant for the recovering of visual function in children. The national basic public health services of China offer the basic visual acuity screening every year for free. In this study, the investigators try to explore the cost-effective and compliance of the national basic public health services based tertiary care model for the management of visual development disorders among preschool children. This Tertiary care based on disease management model among preschool children was conducted at Yudu county, Jiangxi province, in China. Preschool vision screening relied on the national basic public health services of China (refractive errors examined by the Retinomax autorefractor). Children who failed the screening were randomized into two groups, the intervention group: their parents will be informed and transferred to an ophthalmologist and optometrist at Ophthalmic Referral Center, receiving basic eye examination and therapy (visual corrected by glasses and periodic review); The control group: their parents will be informed and suggest them to take their children to the hospital for further examination by themselves.

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
None

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients who are aged 4-7 years and of Chinese citizen
  • Who is willing to sign the consent form
  • Children at the kindergarten will receiving the eye diseases screening of public health equalization programs in China, and there are abnormal findings after screening

排除标准

  • Unwilling to sign the consent form
  • Exiting eye diseases and already receiving therapies and follow up

研究组 & 干预措施

Tertiary care

Experimental

干预措施: Tertiary care (Other)

Usual care

Active Comparator

干预措施: Usual Care (Other)

结局指标

主要结局

The consultation rate in six month after the parents receiving the visual screening report

时间窗: 6 months

The consultation rate will be determined by the number of children who had visual screening abnormal actually go to hospital for consultation by telephone follow-up.

次要结局

  • The cost-effective of the tertiary care for visual developmental disorders(6 months)

研究者

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

Yizhi Liu

Clinical Professor,director of Zhongshan Ophthalmic Center

Zhongshan Ophthalmic Center, Sun Yat-sen University

研究点 (1)

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