NCT07229352尚未招募不适用
Mobility Performance in Daily Activities Among Children Wearing Single Vision and Myopia Control Spectacle Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reaction time: the time elapsed between the appearance or activation of a visual stimulus and the initiation of the participant's physical response
研究概览
简要总结
The aim of this study is evaluate and compare the mobility performance of children in daily activities while wearing single vision spectacle lenses (control) versus myopia control spectacle lenses (test).
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A participant is eligible for inclusion in the study if they meet the following criteria:
- •Are between the ages of 6 and 12 years of age (inclusive) at the time of informed consent/assent.
- •Can achieve a corrected visual acuity of 20/20 best-corrected (or equivalent logMAR).
- •Have undergone a self-reported oculo-visual examination within the past two years.
- •Have no active ocular disease.
- •Are willing and able to adhere to instructions, study procedures, and maintain the appointment schedule.
- •Have not previously worn or participated in myopia control contact lenses for more than one month and are not currently undergoing any form of myopia control treatment.
- •The subject's parent(s) or legal guardian(s) must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
排除标准
- •A participant will be excluded from the study if they meet any of the following conditions:
- •Have any systemic disease that affects ocular health.
- •Are currently using or have used, within the past 7 days, any systemic or topical medications that may impact ocular health.
- •Are currently using or have used any topical ophthalmic agents with anti-muscarinic properties within 7 days prior to enrollment or at any point during the study. This includes, but is not limited to, atropine, scopolamine, pirenzepine, tropicamide, cyclopentolate, and homatropine.
- •Have used any oral agents with anti-muscarinic properties for a chronic period (2 months or more) or short-term (within 7 days prior to enrollment). This includes, but is not limited to, gastrointestinal anti-spasmodic medications containing atropine, hyoscyamine, and dicyclomine.
- •Have known developmental delays.
- •Have participated in another clinical study in the last 7 days
结局指标
主要结局
Reaction time: the time elapsed between the appearance or activation of a visual stimulus and the initiation of the participant's physical response
时间窗: 2 months
Movement time: the time taken to complete the motor response after it has been initiated.
时间窗: 2 months
Response accuracy: the correctness of the participant's response to each visual stimulus, measured by the number or percentage of correctly identified or responded-to stimuli.
时间窗: 2 months
次要结局
- Gait cycle events, such as initial foot contact with the ground and toe-off. It will be used to assess whether the type of eyewear affects natural gait patterns or mobility during peripheral vision tasks.(2 months)
研究者
研究点 (2)
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