OKKO Space Academy App: Families Checking Their Child's Vision at Home During Amblyopia Treatment
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Variability in app data.
研究概览
简要总结
The purpose of this study is to determine the feasibility of the OKKO Space Academy app as a vision measuring and home-monitoring tool for children aged 3-8 years undergoing amblyopia treatment.
There are three objectives to this work:
- Determine the feasibility of the OKKO Space Academy app for use between clinic visits from the child's and family perspective (i.e., acceptability, usability and engagement).
- Assess the variability in day-to-day OKKO Health measurements between clinic visits (e.g., do the interim OKKO home vision measurements predict improvements in visual acuity?)
- Explore agreement between the OKKO Space Academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3.01 - 8.99 years with amblyopia
- •Currently undergoing or at first visit to start amblyopia patching treatment
- •Vision is fully corrected in glasses
- •Visual acuity between -0.02 and 0.98 logMAR
- •Have daily access to an approved smartphone or tablet
- •Parent/child able to read and understand English
- •Patient (child) able to understand spoken English
排除标准
- •Parent not able to read and understand English
- •Patient (child) not able to understand spoken English
- •Parent/child not willing to participate
- •Parent unable to give consent
- •Any other ocular comorbidities
- •Child has cognitive impairment or intellectual disability
结局指标
主要结局
Variability in app data.
时间窗: 3 months
The variability in day-to-day OKKO Health measurements between clinic visits (e.g., do the interim OKKO home vision measurements predict changes in visual acuity?)
Feasibility and acceptability of home monitoring using the OKKO Health app
时间窗: 3 months
The feasibility and acceptability of the OKKO Space Academy app for use between clinic visits from the child's and family perspective. This will be assessed through a purpose built questionnaire.
Engagement of home monitoring using the OKKO Health app
时间窗: 3 months
The rate of engagement with the OKKO Space Academy app for use between clinic visits by the child (patient) and the family.
Visual acuity
时间窗: 3 months
Exploring the agreement between the OKKO Space Academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability.
次要结局
未报告次要终点