NCT00522288已完成不适用
Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 484
- 试验地点
- 10
- 主要终点
- Global Self-Worth Scale from the Self-Perception Profile for Children
研究概览
简要总结
The purpose of the study is to determine whether contact lens wear will improve children's self-perceptions more than spectacle wear.
详细描述
Eight to eleven year old children will be randomly assigned to wear spectacles or soft contact lenses. The children's self-perceptions will be measured at baseline and every six months. We will compare the change in self-perception between spectacle and soft contact lens wearers over three years. We will also examine the effect of how much children initially like or dislike to wear glasses on the change in self-perception over three years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.00 to 6.00 D spherical component myopia, based on cycloplegic autorefraction
- •1.00 DC or less astigmatism, based on cycloplegic autorefraction
- •20/20 or better best-corrected visual acuity in each eye
- •Global stereoacuity of 250 seconds of arc or better based on Randot stereoacuity
排除标准
- •Contact lens wear within the past month
- •Ocular health problems that could affect vision, eye development, or contact lens wear
- •Systemic health problems that could affect understanding of surveys or contact lens wear
- •Participation in other eye or vision studies that prescribed a treatment
结局指标
主要结局
Global Self-Worth Scale from the Self-Perception Profile for Children
时间窗: 3 years
次要结局
- Five other scales from the Self-Perception Profile for Children(3 years)
- Change in cycloplegic autorefraction(3 years)
- Change in axial length, measured by A-scan ultrasound(3 years)
- Change in corneal curvature, measured by Grand Seiko WR-5100K autokeratometer(3 years)
- Change in Overall score from the Pediatric Refractive Error Profile(3 years)
研究者
研究点 (10)
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