Shanghai Eye Disease Prevention and Treatment Center
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 3
- 主要终点
- Changes of spherical equivalent
研究概览
简要总结
Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control.
Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one eye with cycloplegic optometric spherical equivalent of -5.00 to -10.00D and best corrected distant visual acuity of at least 0.5 and near visual acuity of at least 1.0, Titmus Stereo acuity ≤ 80 seconds, Vision with external occultation of ≤ 10 prismatic diopters , vision with internal occultation of ≤ 6-8 prismatic diopters, and astigmatism equal to or less than -2.50D;
- •Myopia progression greater than 0.5D in the past year;
- •Possess normal cognitive and verbal communication abilities to actively cooperate with the prescribed treatment;
- •Written informed consent from the guardian and the child.
排除标准
- •Diseases of the study eye: keratitis, cone cornea, congenital cataract, glaucoma, fundus diseases; combined with inflammation of the anterior or posterior segment of the eye, such as acute conjunctivitis, iridocyclitis;
- •Systemic diseases affecting the use of drugs: albinism, epilepsy, severe psychoneurological disorders, congenital heart disease, cardiac arrhythmias;
- •Atropine allergy;
- •Very low birth weight less than 1500 g;
- •Previous treatment with anticholinergics including atropine within the previous 1 year, or use of OK lenses, multifocal soft lenses within 3 months;
- •Other conditions judged by the investigator to be unsuitable for participation in the trial.
研究组 & 干预措施
Group 1
0.01% atropine
干预措施: Atropine (Drug)
Group 2
0.04% atropine
干预措施: Atropine (Drug)
Group 3
0.1% atropine
干预措施: Atropine (Drug)
结局指标
主要结局
Changes of spherical equivalent
时间窗: at least 2 years
Spherical equivalent as measured by cycloplegia autorefraction
次要结局
- Change in axial length(at least 2 years)
- Best corrected vision acuity (BCVA)(at least 2 years)
- Intraocular pressure (IOP)(at least 2 years)
- Pupil size(at least 2 years)
- Accommodative function(at least 2 years)