Efficacy and Safety of Dual-Effect Myopia Control Lenses for Slowing Myopia Progression: A Single-Center, Randomized, Controlled, Noninferiority Trial
This study aims to evaluate the efficacy and safety of dual-effect myopia control spectacle lenses in slowing myopia progression compared with Nikon MyoEase 2.0 lenses in children aged 8-13 years.
This is a single-center, randomized, open-label, parallel-group, noninferiority clinical trial. A total of 194 children with myopia will be randomly assigned in a 1:1 ratio to wear either dual-effect myopia control spectacle lenses or Nikon MyoEase 2.0 lenses for 12 months.
The primary outcome is the change in cycloplegic objective spherical equivalent refraction from baseline to 12 months. Secondary outcomes include changes in refractive error, ocular biometric parameters, visual acuity, binocular visual function, and visual questionnaire scores. Safety will also be assessed throughout the study.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
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:
- Aged 8-13 years, regardless of sex, with written consent from both the participant and their legal guardian.
- Cycloplegic objective spherical equivalent refraction between -4.75 D and -0.75 D (inclusive) in both eyes, astigmatism ≥-1.50 D, and an absolute interocular difference in spherical equivalent refraction ≤1.00 D.
- Best-corrected visual acuity ≥1.0 in both eyes.
- Intraocular pressure within the normal range (10-21 mmHg) in both eyes.
- Voluntary participation in the study with signed informed consent.
Exclusion Criteria:
- History of ocular trauma or intraocular surgery.
- Clinically abnormal slit-lamp examination findings.
- Fundus examination grade ≥2.
- Other ocular diseases, including uveitis or other ocular inflammation, glaucoma, cataract, fundus disease, ocular tumors, ocular trauma, manifest strabismus, or any ocular condition affecting visual function.
- Systemic diseases associated with immunodeficiency or conditions considered by the investigator unsuitable for spectacle wear, such as diabetes, Down syndrome, rheumatoid arthritis, or psychiatric disorders.
- Participation in a drug clinical trial within the previous 3 months or a medical device clinical trial within the previous month.
- Meeting the inclusion criteria in only one eye.
- Inability to attend regular ophthalmic examinations.
- Participation in any myopia control clinical trial within the previous 3 months, or previous or current use of rigid contact lenses (including associated care products), multifocal contact lenses, progressive addition lenses or other specially designed myopia control spectacle lenses, or atropine.
- Deemed ineligible by the investigator.
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：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Dual-Effect Myopia Control Lenses
Participants in this group will wear dual-effect myopia control spectacle lenses for 12 months, with a recommended daily wearing time of at least 12 hours. |
Dual-effect myopia control spectacle lenses manufactured by Jiangsu Kangmeida Optical Co., Ltd. Participants will be advised to wear the spectacles for at least 12 hours per day for 12 months. |
|
有源比较器：Nikon Kongyoudian 2.0 Lenses
Participants in this group will wear Nikon Kongyoudian 2.0 spectacle lenses for 12 months, following the same wearing instructions as the experimental group. |
Nikon Kongyoudian 2.0 spectacle lenses manufactured by Nikon Optical Co., Ltd. The lenses will be used in the same manner as the investigational lenses for 12 months. |
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 |
|---|---|---|
|
Change in Cycloplegic Spherical Equivalent Refraction at 12 Months
大体时间：Baseline and 12 months (±30 days)
|
Change in spherical equivalent refraction (SER) from baseline to 12 months, measured by objective autorefraction under cycloplegia. SER is calculated as sphere power plus half the cylinder power, expressed in diopters (D). |
Baseline and 12 months (±30 days)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Axial Length
大体时间：Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Change in axial length from baseline, measured before cycloplegia using optical biometry. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Change in Cycloplegic Spherical Equivalent Refraction at 6 Months
大体时间：Baseline and 6 months (±30 days)
|
Change in spherical equivalent refraction (SER) from baseline to 6 months, measured by objective autorefraction under cycloplegia, expressed in diopters (D). |
Baseline and 6 months (±30 days)
|
|
Visual Acuity With Study Spectacles
大体时间：Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Visual acuity measured while wearing the assigned study spectacles. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Change in Corneal Curvature
大体时间：Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Change in corneal curvature from baseline, measured before cycloplegia using optical biometry. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Change in Anterior Chamber Depth
大体时间：Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Change in anterior chamber depth from baseline, measured before cycloplegia using optical biometry. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Change in Lens Thickness
大体时间：Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Change in crystalline lens thickness from baseline, measured before cycloplegia using optical biometry. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Change in Subjective Refraction
大体时间：Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Change in subjective refraction from baseline, assessed before cycloplegia. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Best-Corrected Visual Acuity
大体时间：6 months (±30 days) and 12 months (±30 days)
|
Best-corrected visual acuity assessed using an ETDRS logMAR E chart. |
6 months (±30 days) and 12 months (±30 days)
|
|
Change in Binocular Visual Function
大体时间：Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Change in binocular visual function from baseline, assessed at follow-up visits. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Visual Questionnaire Score
大体时间：6 months (±30 days) and 12 months (±30 days)
|
Visual assessment using the Chinese version of the PRER2 questionnaire. |
6 months (±30 days) and 12 months (±30 days)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Adverse Events and Serious Adverse Events
大体时间：Throughout the 12-month study period
|
Occurrence of symptoms, signs, complications, adverse events, and serious adverse events related to the study products or procedures. |
Throughout the 12-month study period
|
|
Intraocular Pressure
大体时间：6 months (±30 days), and 12 months (±30 days)
|
Intraocular pressure measured using non-contact tonometry, expressed in mmHg. |
6 months (±30 days), and 12 months (±30 days)
|
|
Fundus Examination Grade
大体时间：6 months (±30 days), and 12 months (±30 days)
|
Fundus findings assessed and graded according to the study protocol. |
6 months (±30 days), and 12 months (±30 days)
|
|
Spectacle Frame Position Assessment
大体时间：Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Assessment of spectacle frame positioning and lens condition according to the study protocol. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
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
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