NCT07229365招募中不适用
Children's Viewing Behavior in Myopia Control Spectacles
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Activity dependent, gaze location in myopia control spectacles
研究概览
简要总结
The aim of this study is to investigate the area of the spectacle lens in which a subject is viewing through regardless of task being performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Is 7-14 years of age, inclusive
- •Requires spherical spectacle lenses within the power range available for the study lenses
- •Parent/guardian has read and understood the informed consent form, and the child has provided age-appropriate assent
- •Is willing and able to follow instructions and maintain the appointment schedule
- •Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best corrected
- •Has had a self-reported oculo-visual examination in the last two years
- •Spectacle cylinder of ≤ -0.75DC in both eyes
排除标准
- •A person will be excluded from the study if he/she:
- •Is unable to complete the necessary study activities
- •Has any systemic disease affecting ocular health
- •Is using any systemic or topical medications (including pharmaceutical myopia control therapy) that will affect ocular health
- •Is aphakic
研究组 & 干预措施
SightGlass Vision Test Arm 1
Experimental
Single vision, impact-resistant spectacle lenses
干预措施: Novel spectacle lens design (Device)
SightGlass Vision Test Arm 2
Experimental
Single vision, impact-resistant spectacle lenses
干预措施: Spectacle lenses (Device)
结局指标
主要结局
Activity dependent, gaze location in myopia control spectacles
时间窗: 2 months
Subjective/objective quantification of activity via survey or observation
时间窗: 2 months
Pupil size
时间窗: 2 months
次要结局
未报告次要终点
研究者
研究点 (1)
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