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临床试验/ACTRN12619000374167
ACTRN12619000374167尚未招募未知

Efficacy of Optimised Minus Lens in the Treatment of Intermittent Exotropia: A Randomised Clinical Trial

Children's Health Queensland0 个研究点目标入组 140 人开始时间: 2019年3月11日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
140

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
4 Years 至 15 Years(—)
性别
All

入选标准

  • Age between 4 and 15 years
  • -Patient with IXT measuring >10pd of distance IXT and mean distance control score of 2 points or worse
  • -Best corrected visual acuity 6/9 or better in each eye
  • -Near stereopsis of 100” arc or better
  • -No ocular pathology that might affect ocular motility and visual acuity
  • -Parents willing to and able to provide signed informed consent

排除标准

  • -Constant strabismus/exotropia
  • -IXT of convergence insufficiency type - near deviation not exceeding the distance deviation by >10pd
  • -IXT treated with minus lens, prism or surgery within the last 6 months. Patients receiving alternate pathing will be eligible for the study.
  • -Any previous strabismus and/or intraocular surgery
  • -Interocular difference of visual acuity by 2 or more lines
  • -Cycloplegic spherical equivalent refraction exceeding -6.0D myopia or +2.0D hyperopia on cycloplegic refraction. Ametropic criteria are selected with the assumptions that: myopia over 6.0D for the target age group is likely to be pathological in nature; and hyperopia over 2D is likely to be symptomatic manifest hyperopia which normally should be fully corrected.
  • -Inability to determine accurate visual acuity and strabismus assessment due to poor cooperation and/or intellectual impairment
  • -Conditions potentially affecting vergence and accommodation
  • -Developmental delay or general debility interfering study purpose

研究者

发起方
Children's Health Queensland

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