NCT02241356已完成不适用
The Effect of Bifocals in Children With Down Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- • Change from baseline in visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
研究概览
简要总结
Visual acuity at near improves in children with Down syndrome using bifocals
详细描述
The accommodation is consistently reduced in 50 to 100% of children with Down syndrome and does not improve with age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Down syndrome (DS)
- •Accommodation lag >0.5 Dioptres for children with DS <12 years and >0.75 Dioptres for children older than age 12 or Visual acuity at near is worse than at distance and >0.1
- •Age range 2-14 years
- •Speaks Dutch as the first language
- •Must be verbal or able to understand instructions
- •Must be able to perform a task sitting on a chair and working at a table
排除标准
- •Visual acuity at near < 0.1
- •Not able to do vision tests at age over 5
- •Has worn bifocals already
- •Other significant eye diseases, such as keratoconus, cataract or high myopia (>S-6.00).
- •Diagnoses of any neurological, sensory or behavioural disorders such as autism, microcephaly or significant hearing loss.
- •Prematurity, born premature after a pregnancy term less than 36 weeks
- •Born after severe perinatal problems
结局指标
主要结局
• Change from baseline in visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
时间窗: baseline to 12 months later
visual acuity is measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at baseline and at the end of the study 16 months later. We will calculate the difference.
次要结局
- • Visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.(after 12 months)
- • Change from baseline in visual acuity at distance measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.(baseline to 12 months later)
- • Change from baseline in accuracy of accommodation response measured in Dioptres.(baseline to 12 months later)
- • Change in percentage of participants with strabismus(baseline to 12 months later)
- • Change in score of task readiness of the children(baseline to 12 months later)
研究者
研究点 (2)
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