Clinical Study on the Effectiveness and Safety of Visual Training for Improving Intermittent Exotropia Visual Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 主要终点
- changes in stereoscopic vision function after 12 month
研究概览
简要总结
The goal of this clinical tral is to investigate that if VR/AR visual training can improve the visual function in children with intermittent exotropia.
The main question it aims to answer is :
Does the VR/AR visual training can enhance stereoscopic vision function in children with intermittent exotropia.
Researchers will compare intervention group to control group to see if VR/AR visual training could enhance stereoscopic vision function in children with intermittent exotropia.
Participants will:
The intervention group will receive 20 minutes of VR/AR visual training once a day for a period of one year.
Follow up check ups at the hospital every 3 months. Keep a diary of the values of stereoscopic vision function and Newcastle Control Score.
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
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 6 to 14 years. Intermittent exotropia meeting all of the following criteria: Exodeviation at least 10Δ at distance measured by the prism and alternate cover test, near deviation does not exceed distance deviation by more than 10Δby prism and alternate cover test, mean distance Newcastle Control Score (NCS)≥2 points (mean of 3 assessments during the examination).
- •Refractive error between -5.00 D < spherical equivalents (SEs) ≤ -1.00 D, astigmatism ≤1.50D, anisometropia ≤1.5D, best visual acuity in each eye of 1.
- •Not receiving any other form of strabismus or myopia treatment within 3 months. Willing to follow the research plan and participate in the entire research process.
- •Participants and guardians agree to be randomly assigned and sign an informed consent form.
排除标准
- •Vertical strabismus; Diagnosed with other eye diseases or visual abnormalities such as strabismus, amblyopia, etc; Existence of cognitive or learning disabilities that may affect the effectiveness of training; patients with neurological disorders; Unable to cooperate with eye examination and follow-up work.
研究组 & 干预措施
VR/AR visual training group
Wear glasses for correction combined with VR/AR visual training in the first 6 months, and terminate the training for follow-up observation in the last 6 months. Regular follow-up every 3 months, with a total follow-up time of 1 year.
干预措施: VR/AR visual training group (Device)
control group
No intervention, simply wearing glasses for correction, followed up every 3 months for a total of 12 months.
结局指标
主要结局
changes in stereoscopic vision function after 12 month
时间窗: 12 month after baseline
Stop the intervention group training after 6 months and observe for another 6 months to see if there will be a decrease in stereoscopic vision function.
changes in stereoscopic vision function after 6 month
时间窗: 6 months after baseline
Compare whether the intervention group has better stereoscopic vision function than the control group after 6 months
次要结局
未报告次要终点