Myopia Control Combined PBM With Myopic Defocus Lens in Children: Double-blind RCT for 6 Month
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- SE (Diopter, D)
研究概览
简要总结
To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.
详细描述
myopic children with age from 6 ~13 years old. And refraction from -0.50D~-5.50D.
The red light is low lever laser therapy at wavelength of 650nm.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent by the supervision of the children
- •6~13 years old (including both the 6 and 13)
- •SE range: -0.50~-5.50D
- •Astigmatism <=2.00D
- •BCVA >=0.8
- •Anisometropia <=1.50D
- •Confirmed to no use of other myopia control intervention
排除标准
- •Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.)
- •Halo, glare, toutic, ADHD, psoriasis
- •Systom disease: immune disease, central nerve system, Down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction.
- •Squint, ocular lesion or acute imflammation.
- •Other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, multi-focus soft lens, multi-function spectacles.
结局指标
主要结局
SE (Diopter, D)
时间窗: 6 month
changes of cycloplegic spherical equivalent from baseline will be measured under cycloplegic refraction by autorefractor. Five measured by the same autorefractor are to be obtained for each eye.
axial length (mm)
时间窗: 6 month
Axial length changes at follow-up of 6 month from baseline will be measured by IOLmaster 500 at the same site by the same examiner with the mean values of 5 times measurements at either time. Changes in axial length (mm) without cycloplegia are to be measured by IOLmaster(Carl Zeiss). Five measurements will be taken and then averaged.
次要结局
- SFCT （um)(6-month)
- UCVA (logMar visual acuity record)(6 month)
- BCVA (logMar visual acuity record)(6 month)
- OCT(6-month)