佩戴眼镜镜片儿童日常活动中的移动能力表现
佩戴单光与近视防控镜片儿童日常活动中的行动能力表现
The aim of this study is evaluate and compare the mobility performance of children in daily activities while wearing standard single vision spectacle lenses and myopia control spectacle lenses.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Jennifer Hill
- 电话号码:6783614877
- 邮箱:jhill@sightglassvision.com
学习地点
-
-
Arizona
-
Glendale、Arizona、美国、85308
- 招聘中
- Midwestern University Arizona College of Optometry
-
接触:
- Javier Gantes-Nunez
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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.
Exclusion Criteria:
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:SightGlass Vision Test Arm 1
Single vision, impact-resistant spectacle lenses |
Use of lenses to correct myopia and may reduce the rate of progression of juvenile myopia |
|
有源比较器:Control Arm
Single vision, impact-resistant spectacle lenses |
Use of lenses to correct myopia and may reduce the rate of progression of juvenile myopia |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
反应时间:从视觉刺激出现或激活到参与者开始做出物理反应之间所经过的时间
大体时间:2个月
|
2个月
|
|
运动时间:启动运动反应后完成该动作所需的时间。
大体时间:2个月
|
2个月
|
|
反应准确度:参与者对每个视觉刺激作出反应的正确性,通过正确识别或反应的刺激数量或百分比来衡量。
大体时间:2个月
|
2个月
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
步态周期事件,例如脚部初次接触地面和脚尖离地。将用于评估在周边视觉任务中,不同类型的眼镜是否会影响自然步态模式或移动能力。
大体时间:2个月
|
2个月
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.