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临床试验/NCT06714994
NCT06714994尚未招募不适用

Effect of Spectacle Distribution to Myopic Secondary School Students in Rural Communities of Liaoning Province on Communities Academic High School Enrolment

He Eye Hospital1 个研究点 分布在 1 个国家目标入组 1,980 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,980
试验地点
1
主要终点
Attendance at academic high school

研究概览

简要总结

To determine whether provision of free spectacles to rural-dwelling Chinese secondary school students with visually-significant refractive error, together with a teacher-based incentive to promote their use, increases the proportion of children going on to academic high school, as opposed to dropping out or pursuing a vocational track.

详细描述

The investigators propose in the current trial to significantly expand the evidence base for spectacle distribution as the most-effective health intervention to improve educational opportunities for China's under-served rural children and adolescents by assessing impact on school attainment.

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 (Investigator)

入排标准

年龄范围
11 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Year 1 students (about 12-15 years old) from schools in county-level cities and below in Liaoning Province
  • Uncorrected (self-glasses) visual acuity of ≤6/12 in both eyes
  • Refractive error meets cut-offs shown to be associated with significantly greater improvement in visual acuity when corrected7 (myopia ≤-0.75 diopters (D, or astigmatism (non-spherical refractive error) ≥1.00 D
  • Best corrected visual acuity ≥6/7.5 in either eye

排除标准

  • Hyperopia ≥2.00 D
  • Presence of visually-significant ocular condition besides refractive error

结局指标

主要结局

Attendance at academic high school

时间窗: In July following completion of Year 3 of Middle School. This occurs after 32 months of participant followup.

This will be assessed by systematically contacting parents, teachers and students to ascertain enrolment status, which REAP has used to obtain \> 97% follow-up in previous studies of high school accession. In the event of inconsistent responses, priority will be given to responses of parents, then teachers and finally students

次要结局

  • Compliance with spectacle wear(After 12 months of participant followup)
  • Classroom use of blackboards versus textbooks(After 12 months of participant followup)
  • Cost effectiveness of intervention.(At study closeout, after 32 months of participant follow up)
  • Depression and Anxiety(At baseline and 12 months post-treatment)
  • Self Esteem(At baseline and 12 months post-treatment)
  • Emotional and behavioral problems(At baseline and 12 months post-treatment)
  • Progression of Shortsightedness(At baseline and 12 months post-treatment)

研究者

发起方
He Eye Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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