Effectiveness and Safety of Partition Multi-point Defocused Myopia Management Spectacle Lens in Myopia Control Compared With Spectacle Lenses With Aspherical Lenslets: a Randomised Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 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
Myopia is considered to be the most common type of refractive error, and the incidence of myopia has shown a trend of low age. Recent studies found that the new aspheric microlens spectacle lens can more effectively control the progress of diopter than the single-vision spectcale lens. A new technology of equivalent defocusing around the lens called the partition multi-point defocus optical technology is adopted in this study.
详细描述
Myopia is considered to be the most common type of refractive error, and it has increased rapidly worldwide. The vision damage caused by uncorrected myopia seriously affects the quality of life, may lead to poor academic performance of children, and cause considerable economic burden. About 90% of vision damage caused by myopia can be prevented by cost-effective interventions or treatment.
In recent years, the incidence of myopia has shown a trend of low age. Therefore, clinical intervention should be carried out in the childhood stage, which is the key period of eye development, to control the progress of myopia. A recent 2-year randomized controlled study in China found that the new aspheric microlens myopia control spectacle lens can more effectively control the progress of diopter than the single-vision spectcale lens. Different studies have found or proved the technical principle of the new aspheric defocusing microlens.
Animal experiments found that the direction, intensity and regional distribution of optical defocus signals have a substantial impact on the growth of eyes; The diopter of peripheral relative hyperopia can affect the central myopia; The changes of myopia and optical defocus in the nasal and temporal regions can change the shape and peripheral refraction of the eyes; Local changes in the effective focus of the eye will lead to regional changes in eye growth and refractive error. Based on the findings of animal experiments, the new technology of equivalent defocusing around the lens called the partition multi-point defocus optical technology is adopted in this study.
A prospective, single-center, open-label, non-inferiority randomized controlled trial is developed to evaluate the effectiveness and safety of partition multi-point defocused myopia management spectacle lens among children in China in myopia control.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 8 to 13 years;
- •Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.75 to -4.75 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.00 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 nursing products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.
研究组 & 干预措施
Intervention group
The participants wear the partition defocus myopia management spectacle lens.
干预措施: Partition defocus myopia management spectacle lens (Other)
Control group
spectacle lenses with aspherical lenslets
干预措施: Spectacle lenses with aspherical lenslets (Other)
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 from baseline. SER will be measured every year after cycloplegia.
次要结局
- Choroidal thickness at two years(2 years)
- Changes of axial length (AL) at two years(2 years)
- Change of lens thickness (LT) at two years(2 years)
- Time length of wearing spectcales at two years(2 years)
- Safty of wearing the spectacle lens(2 years)
- Binocular visual function at two years(2 years)
- Change of anterior chamber depth (ACD) at two years(2 years)
- Change of corneal power (CP) at two years(2 years)
- Best corrected visual acuity at two years(2 years)
- Visual scale score at six months(6 months)
- Visual scale score at two years(2 years)