Safety and Effectiveness of CARE1.02 Spectacle Lens Versus Single-vision Spectacle Lens in Myopia Control: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 796
- 试验地点
- 1
- 主要终点
- Changes of spherical equivalent refraction (SER) at one year
研究概览
简要总结
China is a major country in myopia, with the highest number of teenagers suffering from myopia. Controlling the progression of myopia and the related complications caused by axial elongation have clinical significance and social value. Currently. There is a lack of researches on the impact of specially designed myopia control spectacle lens in adolescents aged 12 and above. Therefore, The researchers plan to conduct a randomized controlled trial among myopia adolescents aged 12-17 in middle and high schools in Guangzhou, to test and verify the safety and effectiveness of CARE1.02 on myopia control compared with single-vision spectacle lens.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12 to 17 years;
- •Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.50 to -8.00 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 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
CARE1.02
干预措施: CARE1.02 (Device)
Control group
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 one year
时间窗: 1 year
The difference of SER at one year from baseline. SER will be measured after cycloplegia
次要结局
- Best corrected visual acuity at one year(1 year)
- Binocular visual function at one year(1 year)
- Changes of axial length (AL) at one year(1 year)
- Change of corneal curvature (CR) at one year(1 year)
- Time length of wearing spectcales at one year(1 year)
- Change of anterior chamber depth (ACD) at one year(1 year)
- Change of lens thickness (LT) at one year(1 year)
- Choroidal thickness at one year(1 year)
- Visual scale score at 1 year(1 year)
- Safty of wearing the spectacle lens(1 year)