NCT00787579已完成不适用
Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Myopia progression, measured by cycloplegic autorefraction
研究概览
简要总结
- To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.
- To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children.
- To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.
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
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 8 to 13 years
- •Myopia: -1.00 to -5.00 D
- •Myopia progression: at least 0.50 D/yr
- •Astigmatism and anisometropia: not more than 1.50 D
- •Distance monocular visual acuity: 6/6 or better
- •Near monocular visual acuity: 0.4 M or better
- •Stereoacuity: not more than 40 sec of arc at 40 cm
排除标准
- •Strabismus
- •Ocular diseases
结局指标
主要结局
Myopia progression, measured by cycloplegic autorefraction
时间窗: Every 6 months
次要结局
- Axial length, measured by A-scan ultrasonography(Every 6 months)
研究者
研究点 (2)
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