Effect of WRAD Lens on Axial Growth and Refraction in Low-hyperopic Chinese Children
2026年6月26日 更新者：He Eye Hospital
Myopia is one of the most common visual impairments worldwide.This not only poses long-term risks to individual health but also imposes significant medical and economic burdens on society.
[6] Therefore, delaying the onset of myopia and effectively controlling its progression has become an urgent issue that needs to be addressed.In recent years, a new type of highly aspherical lenslet (HAL) has been proposed.
Its optical design includes a refractive correction area in the central region and a peripheral annular area.
This annular area can form a "myopic defocus zone", increasing the myopic defocus signal around the retina.
Studies have confirmed that this design can effectively slow down the progression of myopia in already myopic children.
However, it is currently unclear whether this lens has a preventive effect on children who are not yet myopic but have a risk of developing myopia.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
117
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Guanghao Qin
- 电话号码：+8618842664420
- 邮箱：qinguanghao2020@163.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
是的
描述
Inclusion Criteria:
- Children aged 6 to 9 with low hyperopia, regardless of gender
- The refractive error is between 0 and 2.00D
- The best corrected visual acuity of both eyes is ≥ 0.10 LogMAR
- The subjects themselves and their guardians voluntarily participated
Exclusion Criteria:
- Systemic diseases or eye diseases
- Received myopia control treatment through medication or optical
- Any situation where participation is deemed unsuitable by the investigator
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group A
Participants will be wearing with-the-rule astigmatic defocus lens glasses.
The lens was prescribed with 0.00 diopters.
It is recommended to wear it for ≥ 10 hours per day
|
The lens was prescribed with 0.00 diopters
|
|
实验性的：Group B
Participants will be wearing with-the-rule astigmatic defocus lens glasses (non-plano defocus spectacles); the central optical zone degree completely correct their baseline under cycloplegia refractive errors.
It is recommended to wear it for ≥ 10 hours per day
|
The magnitude of the central optical zone completely corrected their refractive errors under baseline cycloplegia
|
|
安慰剂比较：Group C (control group)
Participants will be wearing traditional single vision lens, lens has no correction function.
It is recommended to wear it for ≥ 10 hours per day
|
The lenses do not have corrective functions
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in the axial length
大体时间：baseline, 6-month, 12-month, 18-month, 24-month
|
The changes in axial length of the eyes in the experimental group and the control group in the first and second years
|
baseline, 6-month, 12-month, 18-month, 24-month
|
|
Change in the spherical equivalent
大体时间：Baseline, 6-month, 12-month, 18-month, 24-month
|
The changes in spherical equivalent in the experimental group and the control group in the first and second years
|
Baseline, 6-month, 12-month, 18-month, 24-month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in axial length
大体时间：Baseline, 6-month, 12-month, 18-month, 24-month
|
Changes in axial length from baseline to year 1 and year 2 in the plano defocus and non-plano defocus experimental groups.
|
Baseline, 6-month, 12-month, 18-month, 24-month
|
|
Change in equivalent spherical
大体时间：Baseline, 6-month, 12-month, 18-month, 24-month
|
Changes in spherical equivalent refraction from baseline to year 1 and year 2 in the plano defocus and non-plano defocus experimental groups.
|
Baseline, 6-month, 12-month, 18-month, 24-month
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2029年12月1日
研究完成 (估计的)
2030年7月1日
研究注册日期
首次提交
2026年6月26日
首先提交符合 QC 标准的
2026年6月26日
首次发布 (实际的)
2026年7月6日
研究记录更新
最后更新发布 (实际的)
2026年7月6日
上次提交的符合 QC 标准的更新
2026年6月26日
最后验证
2026年6月1日
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.