NCT01267500终止不适用
Randomized Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Control of strabismus
研究概览
简要总结
Non-surgical treatment (ie. patching or fusion exercises) of intermittent exotropia may help in increasing control of strabismus
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 3 to 12 years (inclusive)
- •IXT for distance or constant IXT for distance and either IXT or exophoria for near
- •IXT size of > 10PD
- •Visual acuity in worse eye of at least 0.3 logMar (Snellen 6/12)
- •Visual acuity of no greater than 2 lines between eyes
- •Parents or guardian willing to accept randomization, and to continue with observation or treatment for at least 6-12 months, unless deterioration of strabismus or fall in best corrected visual acuity of worse than 0.3logMar (Snellen 6/12) in either eye
- •Investigator willing to observe IXT untreated for at least 1 year
排除标准
- •Previous non-surgical treatment for IXT, or patch treatment for amblyopia within the last year
- •Prior strabismus, intraocular or refractive surgery or botulinium injection
- •Surgery planned within the next year
- •Prematurity (birth weight < 1500g, gestational age < 34 weeks), systemic illness (eg. cerebral palsy), syndrome (including craniosynostosis) or learning disability
- •Any ocular abnormality (cornea, lens or central retina); nystagmus or conditions that limit eye movements.
研究组 & 干预措施
Non-surgical therapy
Experimental
patching or fusion exercises
干预措施: Non surgical therapy (Procedure)
结局指标
主要结局
Control of strabismus
时间窗: 1 year
次要结局
未报告次要终点
研究者
Audrey Chia Wei-Lin
Senior Consultant
Singapore National Eye Centre
研究点 (1)
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