NCT06250920已完成不适用
Effect of Virtual Reality-Based Visual Training for Myopia Control in Children: a Randomized Controlled Trial
Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2020年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- changes in axial length
研究概览
简要总结
To assess the efficacy and safety of virtual reality-based visual training (VRVT) in myopia control among children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age 8-13 years old (inclusive), regardless of gender;
- •The spherical equivalent of both eyes after cycloplegia was -3.00D to -0.50D (including);
- •Binocular astigmatism ≤3.00D during screening;
- •Anisometropia (according to spherical equivalent) ≤1.50D during screening;
- •The intraocular pressure of any eye during screening was ≤21mmHg;
- •At the time of screening, the best corrected distance visual acuity of any eye was ≥1.0 or LogMAR≤0;
- •Good binocular stereopsis and stereopsis acuity ≤60 ";
- •The subjects and their legal guardians were willing to participate in the study and signed written informed consent.
排除标准
- •Existing or previous history of ophthalmic organic diseases, ophthalmic surgery, and obvious strabismus after wearing glasses;
- •Using orthokeratology lenses, feeding instrument and other myopia prevention and control methods that may affect the study in the past 6 months;
- •Subjects with poor vestibular function such as motion sickness and seasickness;
- •Any history of diseases or syndromes that may cause severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.); 5, any eye refractive media abnormalities (such as cornea, lens abnormalities, etc.);
- •Long-term use (i.e., more than 7 consecutive days in 1 month or more than 30 days in total in 1 year) of any local or systemic use of anticholinergic/anticholinergic drugs (e.g., atropine, scopolamine, tolacamide, etc.) within 21 days before screening and during the expected period of the study, allowing the use of cycloplegic drops for optometry and other examinations;
- •Severe systemic disease considered by the investigator as not suitable for the study;
- •Participation in other clinical trials within 30 days before screening;
- •Only one eye met the inclusion criteria;
- •Poor compliance, unable to go to medical institutions for treatment on a timely and regular basis as required;
- •Any other circumstances deemed inappropriate by the investigator to participate in the study.
结局指标
主要结局
changes in axial length
时间窗: baseline and the 3-month follow-up visits
次要结局
- changes in subfoveal choroidal thickness(baseline and the 3-month follow-up visits.)
研究者
Jing Yu
Dr
Shanghai 10th People's Hospital
研究点 (1)
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