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
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