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临床试验/NCT00317551
NCT00317551已完成2 期

Accommodation Training and Aberration Control in Myopia Development

Anglia Ruskin University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
200
试验地点
2
主要终点
Change in refractive error in myopia in 6 monthly intervals for 2 years

研究概览

简要总结

We have identified focussing problems related to myopia getting worse. Our trial uses optical and orthoptic interventions that correct the focussing problems to see if this retards myopia progression.

详细描述

Myopia is a burgeoning health and social problem. Currently there is no acceptable clinical treatment that prevents progression. This study is a double masked placebo controlled block randomized clinical trial of two interventions, to treat accommodative factors we have identified as being significantly correlated to myopia progression (rather than to the presence of myopia). We have shown that the interventions normalise the accommodative factors, and this trial examines the effect of these interventions on myopia progression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double

入排标准

年龄范围
14 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Best corrected visual acuity of 6/5 in each eye
  • Myopia in each meridian of at least 0.50 D
  • Willingness to give consent
  • Willingness to undertake any treatment option

排除标准

  • History of systemic/ocular pathology
  • History of any ocular surgery
  • More than 10D of myopia
  • Astigmatism more than 1.00 D

结局指标

主要结局

Change in refractive error in myopia in 6 monthly intervals for 2 years

Change in axial length in 6 monthly intervals for 2 years

Age effects on refractive changes over 2 years

次要结局

  • Change in accommodative response in 6 monthly intervals for 2 years
  • Change in accommodative facility in 6 monthly intervals for 2 years
  • Change in peripheral refraction in 6 monthly intervals for 2 years
  • Change in AC/A ratio in 6 monthly intervals for 2 years

研究者

申办方类型
Other

研究点 (2)

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