Naked Eye 3D Vision Training for the Prevention and Control of Myopia in Adolescents and Children
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 主要终点
- the change of axial length
研究概览
简要总结
The study used children aged 6-18 as subjects to evaluate the efficacy and safety of naked eye 3D vision training for the prevention and control of myopia in adolescents. A total of 250 subjects were recruited from Zhongshan Ophthalmology Center of Sun Yat-sen University, Shenzhen People's Hospital and Foshan Women's and Children's Hospital, with 1:1 as intervention group and control group. The study assumes that daily naked eye 3D vision training can effectively control the speed of axial elongation and the progression of myopia. The main indicators were the use of optical biometrics to detect the subjects' initial axial length and the axial length after 1 month, 3 months and 6 months of intervention. Secondary indicators were refraction, uncorrected visual acuity, best corrected visual acuity, choroidal thickness, and binocular vision.
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
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6~18 years old (including 6 years old and 18 years old), gender is not limited;
- •Written informed consent signed by the child and legal guardian has been obtained;
- •Patients who have visited the research center in the past month, diagnosed as myopia according to the "Guidelines for the Prevention and Treatment of Myopia" issued by the General Office of the National Health Commission (Guoweiban Medical Letter [2018] No. 393), and the spherical equivalent power is -0.75 to -6.00 Diopter (D) (including -0.75 and -6.00 D);
- •Astigmatism≤4.00 D, anisometropia≤4.00 D;
- •Monocular international standard logarithmic visual acuity after spectacle correction ≥20/25;
- •The subject's guardian can understand the purpose of this study, and the subject can cooperate with the treatment and related eye examinations.
排除标准
- •Any eye of the subject suffers from overt strabismus, or any other pathological changes in the eyeball or acute inflammatory disease of the eye;
- •Subjects who may suffer from eye diseases that affect vision or refractive errors (such as cataract and other lens damage diseases, glaucoma, macular degeneration, keratopathy, uveitis, retinal detachment, severe vitreous opacity, etc.);
- •Systemic diseases: those with a history of immune system diseases, central nervous system diseases, Down syndrome, asthma, severe heart and lung function, severe liver and kidney dysfunction;
- •Binocular hyperopia cannot be corrected to logarithmic visual acuity of 20/25;
- •The subject has or is undergoing myopia control treatment within the past 1 month, such as atropine eye drops, orthokeratology lenses, progressive lenses, bifocal lenses, etc.;
- •Photophobia or unable to open eyes normally due to keratitis, trichiasis, trauma, etc. in any eye of the subjects;
- •Subjects participated in other clinical studies 4 weeks before enrollment;
- •For safety reasons or the interests of patients, the investigator believes that patients should not participate in other situations in this study.
研究组 & 干预措施
intervention group
干预措施: Naked eye 3D vision training (Behavioral)
control group
结局指标
主要结局
the change of axial length
时间窗: baseline, 1st months, 3rd months, 6th months
mm
次要结局
- the change of vision(baseline, 1st months, 3rd months, 6th months)
- the change of adjustment range(baseline, 1st months, 3rd months, 6th months)
- the change of choroidal thickness(baseline, 1st months, 3rd months, 6th months)
- the change of adjust sensitivity(baseline, 1st months, 3rd months, 6th months)
研究者
Yehong Zhuo
Clinical Professor
Zhongshan Ophthalmic Center, Sun Yat-sen University