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临床试验/NCT02231606
NCT02231606已完成不适用

Potentiating Rural Investment in Children's Eyecare (PRICE)

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 10,234 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10,234
试验地点
1
主要终点
Glasses purchase proportion

研究概览

简要总结

The aim of the project is to create, study and advocate for a model that can be adopted by the Chinese government to provide spectacles for all children sustainable.

详细描述

Uncorrected refractive error (URE) is the leading cause of visual impairment among Chinese children, accounting for 90% or more of poor vision, and Chinese children have among the highest rates of myopia in the world. Despite the fact that the problem of URE is safely and inexpensively treated with glasses, only 15-40% of children needing them own and wear glasses sufficient to provide good vision in rural China.

PRICE (Potentiating Rural Investment in Children's Eyecare) will use a randomized, controlled design across 4 groups of all 138 schools in Yunnan (one of China's poorest provinces) and Guangdong (one of the richest) to optimize the model of "free glasses for all with an optional upgrade." The selection of free spectacles and cost of the "upgrade" options will be varied between groups in order to find the optimal balance between high rates of purchase of upgrade glasses on the one hand and good acceptance and wear of free spectacles among those selecting them on the other.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Randomly selected primary schools, which has all 3, 4 and 5 grades, in the 9 project counties.
  • A class randomly selected from each grade of 3, 4, and 5 grades of the selected primary schools.
  • All children in the selected classes.

排除标准

  • Those schools that the total number of students are more than
  • Those schools that the total number of students of 3, 4, 5 grades are less than
  • Children suffering from eye diseases such as cataract, congenital ptosis, strabismus, congenital glaucoma will not be included in the study and will be recommended referral.

结局指标

主要结局

Glasses purchase proportion

时间窗: 8 months after the start of the project.

Proportion of children in each group requiring glasses whose families select to purchase them.

次要结局

  • Wearing spectacles proportion(8 months after the start of the project.)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Congdon Nathan

Professor, MD,MPH

Sun Yat-sen University

研究点 (1)

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