'Validation and Development of New Dichoptic VR-gaming Method to Treat Childhood Amblyopia; Vedea Amblyopia Therapy (VAT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Change from baseline in Visual Acuity measured in LogMAR lines
研究概览
简要总结
The purpose of this clinical study is to validate the effectiveness of the Vedea Amblyopia Therapy (VAT) as a treatment for children with lazy eye.
The main question it aims to answer is to prove that the VAT is as effective or more effective than the current gold standard for treating children with lazy eye. This is occlusion therapy by patching the dominant eye.
Participants will play VR-games specifically designed for children with lazy eye for 30 minutes per day, 5 days per week for 16 weeks. This group of children will be compared to children that undergo regular occlusion therapy to see how both treatments options compare.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •wearing the full corrected refraction for ≥14 weeks to adapt to the glasses
- •diagnosed with an unilateral anisometropic, strabismic and/or deprivation amblyopia.
- •Amblyopia was defined as an intraocular difference (IOD) in visual acuity (VA) of 0.2 log MAR (2 lines) or more. Angle of strabismus ≤ 10 prism diopters at near and distance fixation. Current clear media (in case of deprivation amblyopia after successful surgery).
- •currently under treatment or starting treatment for unilateral amblyopia
- •participants must have easy access to an Android device equal to or higher than a Samsung Galaxy S8
- •written informed consent by parents or legal guardians
排除标准
- •current treatment with atropine penalisation
- •documented history of severe negative side effects that occur with exposure to VR usage (eg. seizures or epileptic spasms)
- •photosensitivity
- •no developmental delay
- •coexisting ocular pathology or systemic diseases
结局指标
主要结局
Change from baseline in Visual Acuity measured in LogMAR lines
时间窗: Each clinical visit (approximately 1 month)
The LogMAR method is a validated and often used method of measuring visual acuity in children (with or without amblyopia). Possible scores range from 0 (perfect vision) to 1.0 or higher as really bad vision.
次要结局
- Treatment adherence to the VAT defined as time played per day(Daily registration of time played up to week 16)
- Rate of change in visual acuity outcomes(Each clinical visit (approximately 1 month))