Guangke Lenses in Congenital Cataract
Investigation of Guangke Lenses' Efficacy in Delaying Myopia Onset/Progression in Postoperative Congenital Cataract Children
研究概览
地位
条件
详细说明
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：Jin Yang, Dr.
- 电话号码：021-64377134
- 邮箱：jin_er76@hotmail.com
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200031
- 招聘中
- Eye & ENT Hospital of Fudan University
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接触：
- Jin Yang, PhD
- 电话号码：13671632525
- 邮箱：jin_er76@hotmail.com
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-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
Aged 4 to 12 years (inclusive) at the time of enrollment. Diagnosed with bilateral congenital cataracts. Has undergone bilateral cataract extraction with intraocular lens (IOL) implantation.
Time since cataract surgery is between 1 to 6 months (inclusive) at the time of enrollment.
Able to undergo regular ophthalmic examinations (including refraction, axial length measurement, and intraocular pressure assessment).
Parent(s) or legal guardian(s) are willing and able to provide written informed consent.
Exclusion Criteria:
Presence of any systemic disease (e.g., metabolic disorders, autoimmune diseases, genetic syndromes, etc.).
Presence of any ocular disease other than congenital cataracts (e.g., glaucoma, uveitis, retinal disorders, corneal diseases, strabismus, amblyopia, etc.).
Previous or current use of myopia control treatments, including but not limited to atropine eye drops, orthokeratology (Ortho-K) lenses, or other myopia control spectacle lenses.
History of ocular trauma or intraocular surgery other than cataract extraction and IOL implantation.
Known allergy or hypersensitivity to any materials or components used in the study lenses.
Inability to comply with the study protocol or complete scheduled follow-up visits.
Participation in another interventional clinical trial within the past 30 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：非随机化
- 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 |
|---|---|
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有源比较器：Active Comparator: Conventional Bifocal Lenses
Participants in this arm will wear conventional bifocal spectacles (without defocus design).
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Standard conventional bifocal spectacles without peripheral defocus design.
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实验性的：Experimental: Individually Customized Bifocal + Defocus Lenses
Participants in this arm will wear individually customized bifocal spectacles with peripheral defocus design.
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Individually customized bifocal spectacles with peripheral defocus design for myopia control.
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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 |
|---|---|---|
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Change in Axial Length (AL)
大体时间：Baseline to 12 months
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Change in axial length (in millimeters) from baseline measured by optical biometry.
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Baseline to 12 months
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Change in Spherical Equivalent Refraction (SER)
大体时间：Baseline to 12 months
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Change in spherical equivalent refraction (in diopters) measured by cycloplegic autorefraction from baseline.
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Baseline to 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Corneal Curvature
大体时间：Baseline to 12 months
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Change in corneal curvature (in millimeters) measured by corneal topography.
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Baseline to 12 months
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Change in Intraocular Pressure (IOP)
大体时间：Baseline to 12 months
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Change in IOP (in mmHg) measured by non-contact tonometry.
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Baseline to 12 months
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Incidence of Adverse Events
大体时间：Baseline to 12 months
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Number of participants with ocular or systemic adverse events related to the study lenses.
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Baseline to 12 months
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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
与本研究相关的术语
其他研究编号
- Guangke lenses_2025
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.