NCT06647160进行中（未招募）不适用
Safety and Efficacy of Blue Star MAX-5 Lenses in Mvopia Control: A Randomized Controlled Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes of spherical equivalent refraction (SER) at two years
研究概览
简要总结
The goal of this randomised controlled clinical trial is to compare the effects of a new type of concentric columnar microstructure lens and single-vision spectacle lenses on myopia progression in Chinese children aged 8-11 years with refractive error ranging from -0.50D to -6.00D. Participants will wear spectacles and receive follow-up examinations every half year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 8 to 11 years;
- •Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -6.00 to -0.50 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D;
- •Best-corrected visual acuity of equal or better than 0.00 LogMAR (>= 1.0 as Snellen).
- •The intraocular pressure of 10 to 21mmHg.
- •Volunteer to participate in this clinical trial with signature of the informed consent form.
排除标准
- •History of eye injury or intraocular surgery;
- •Clinically abnormal slit-lamp findings
- •Abnormal fundus examination
- •Ocular disease, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;
- •Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);
- •Participation of the drug clinical trial within three month and the device clinical trial within one month;
- •Only one eye meets the inclusion criteria;
- •Unable to have regular follow-up
- •Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursingproducts), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.
研究组 & 干预措施
Intervention
Experimental
Blue star MAX-5 spectacle lens
干预措施: Blue star MAX-5 spectacle lens (Device)
Control
Active Comparator
Single-vision spectacle lens
干预措施: Single-vision spectacle lens (Device)
结局指标
主要结局
Changes of spherical equivalent refraction (SER) at two years
时间窗: 2 years
The difference of SER (Diopter) at two years compared with baseline SER. SER will be measured after cycloplegia.
次要结局
- Changes of axial length (AL) at two years(2 years)
- Visual scale score at two years(2 years)
- Incidence of adverse event during study period(2 years)
研究者
研究点 (1)
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