此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia (PEARL)

2026年9月18日 更新者:Essilor International

A Paired-Eye Comparison of Myopia Control Lenses in Myopic Children

The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years.

The main question being studied is:

Is the new myopia control spectacle lens more effective than a standard single vision spectacle lens in slowing myopia progression?

In this study, participants will wear a myopia control spectacle lens in one eye and a standard single vision spectacle lens in the other eye for the first 6 months. The lens assignment will then be switched between eyes for the remaining 6 months. Researchers will compare changes in eye axial length and refractive error between the two lens types.

Participants will:

  • Wear the study spectacles for 12 months.
  • Attend scheduled follow-up visits at the Essilor R&D Centre, Singapore.

研究概览

研究类型

介入性

注册 (估计的)

20

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

研究联系人备份

学习地点

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

6年 至 10年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Volunteer participant with the willingness and ability to comply with all scheduled study visits.
  2. Informed consent of parent/guardian and assent of participant.
  3. Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.
  4. Spherical equivalent refraction (SER) equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D.
  5. Difference in SER (anisometropia) between two eyes should not exceed 1.00 D.
  6. Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR under high contrast in each eye.
  7. Be in good general health, based on the participant and the parent's/guardian's knowledge.
  8. Agree to wear the study spectacles for 12 hours per day and 7 days per week.
  9. Agree not to be involved in other myopia control treatments.

Exclusion Criteria:

  1. History of Atropine, Orthokeratology, Myopia Control Contact Lens, or Red Light treatment.
  2. Strabismus by cover test at near or distance wearing correction.
  3. History and presence of amblyopia.
  4. Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
  5. Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
  6. History of ocular injury or surgery.
  7. Participation in any clinical study within 30 days of the Baseline visit.
  8. Current or anticipated use of growth hormones.
  9. Study participants deemed inappropriate for the study by the investigator.
  10. The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.

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:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 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:OD: SVL; OS: MCL then OD: MCL; OS: SVL

Participants will wear the investigational myopia control spectacle lens in the left eye and a standard single vision spectacle lens in the right eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months.

A spectacle lens designed to help slow the progression of myopia in children

A standard spectacle lens used to correct refractive error without a specific myopia control feature

实验性的:OD: MCL; OS: SVL then OD: SVL; OS: MCL

Participants will wear the investigational myopia control spectacle lens in the right eye and a standard single vision spectacle lens in the left eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months.

A spectacle lens designed to help slow the progression of myopia in children

A standard spectacle lens used to correct refractive error without a specific myopia control feature

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change in Eye Axial Length
大体时间:From baseline to 6 months
From baseline to 6 months

次要结果测量

结果测量
大体时间
Change in Eye Axial Length
大体时间:From 6 months to 12 months
From 6 months to 12 months
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
大体时间:From baseline to 6 months
From baseline to 6 months
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
大体时间:From 6 months to 12 months
From 6 months to 12 months

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。

调查人员

  • 首席研究员:Andrew Tan、Essilor R&D Centre Singapore

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10月1日

初级完成 (估计的)

2028年3月1日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2026年9月18日

首先提交符合 QC 标准的

2026年9月18日

首次发布 (实际的)

2026年9月24日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年9月18日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • WS10528

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

订阅