Effect of Vision Therapy on Accommodation in Myopic Chinese Children With Poor Accommodative Response: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- the change of Accommodative response is being assessed
研究概览
简要总结
This study aims to determine the treatment effect of vision therapy on myopic children by assessment of accommodative function before and after therapy.
详细描述
- Specific aims of the proposed clinical trial:
1.1 To provide a definitive proof that vision therapy (VT) can improve the accommodative function of myopic children by comparing the results from treatment group to placebo group.
1.2 To minimize the influences of confounding variables by randomly assigning the intervention.
1.3 To observe the longitudinal effects of VT on accommodation system and its effect on axial length. 2. Hypothesis:
VT can improve the accommodative functions of 8-12 years old Chinese myopic children with poor accommodative response.
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, Investigator)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects enrolled in the trial must:
- •be within the age range of 8 to 12 years old inclusive
- •-0.75D to -4.50Dspherical equivalent by cycloplegic autorefraction in both eyes
- •astigmatism≤1.5D in both eyes
- •anisometropia≤1.0D
- •monocular accommodation lag at near(33cm)in right eye by non-cycloplegic autorefraction≧1D
- •have vision correctable to at least 0.8 or better in each eye.
排除标准
- •Subjects enrolled in the trial must NOT have:
- •current or prior use of PALs, bifocals, or contact lenses in either eye( prior or current use of SVLs allowed)
- •history of any of the following functional defects: strabismus, amblyopia, nystagmus
- •history of diabetes or seizures
- •history of any ocular systemic, or neuro-developmental condition that might influence refractive development
- •use of ocular or systemic medications containing atropine, pirenzepine, and anti-epileptic medications in recent 3 months
- •history of any ocular surgery that might influence refractive development
- •developmental disability, attention deficit hyperactivity disorder(ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with office-based treatment
- •relocation anticipated for 1 year
- •birth weight lower than 1250 grams（2lbs,12oz）
- •siblings in the study.
结局指标
主要结局
the change of Accommodative response is being assessed
时间窗: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
we will use objective measures from open-field auto refractor.
次要结局
- the changes of Cycloplegic objective refraction is being assessed:(At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.)
- the changes of Accommodative facility is being assessed:(At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.)
- the changes of Axial length is being assessed:(At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.)
- the changes of Accommodative amplitude is being assessed:(At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.)
研究者
Xiang Chen
Study Principal Investigator Zhongshan Ophthalmic Center
Sun Yat-sen University