Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Contrast Sensitivity
研究概览
简要总结
Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.
详细描述
This feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages between 6 and 12 years
- •Myopia between -1.00 and -4.00 D
排除标准
- •Participating in any clinical or other research study
- •Contact lens wearer
研究组 & 干预措施
Lens Design 1
Spectacle lenses design 1, fitted into spectacle frames
干预措施: Spectacle lenses (Device)
Lens Design 2
Spectacle lenses design 2, fitted into spectacle frames
干预措施: Spectacle lenses (Device)
Lens Design 3
Spectacle lenses design 3, fitted into spectacle frames
干预措施: Spectacle lenses (Device)
结局指标
主要结局
Contrast Sensitivity
时间窗: 2 weeks
Measurement of contrast sensitivity
Distance Visual Acuity
时间窗: 2 weeks
Measurement of best corrected distance visual acuity
Subjective Responses
时间窗: 2 weeks
Assessment of subject responses related to wear time of spectacles
次要结局
未报告次要终点