A Prospective, Multicenter, Open Label Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction Assessed by GoEyes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 349
- 试验地点
- 24
- 主要终点
- 90% Concordance for sphere power and cylinder power (monocular)
研究概览
简要总结
This study evaluates the reliability, validity and safety of a self administered, subjective refraction test via a mobile medical app (GoEyes) as compared to standard of care subjective manifest refraction performed by a health care provider, in subjects who have no known ocular disease or condition other than refractive error.
详细描述
GoEyes is a Mobile Medical Application, which can be downloaded to a smartphone and is being developed as a self -administered subjective refraction examination that measures the refractive error of the user's eyes in the home environment without any contact or help from health care professionals.
The Study will be conducted in 2 parts; Part 1 and Part 2.
Approximately 59 participants will be enrolled In Part 1. Part 1 participants will have a GoEyes refraction test in clinic on two separate days and will also have a standard of care refraction test performed by a health care provider and best corrected visual acuity assessments.
Approximately 349 participants will be enrolled in Part 2. Part 2 participants will self administer the GoEyes test at home on 2 separate days and will also have in clinic standard of care refraction test performed by a health care provider and best corrected visual acuity assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The Best Corrected Visual Acuity (BCVA) assessor will be masked to GoEyes and Standard of Care refraction results.
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18-39 years who currently wear glasses and/or soft contact lenses to correct refractive error
- •Normal color vision
- •Able to use both hands at the same time and to hear, understand and verbally respond to audio instructions
- •Have single vision lenses only
- •Able to provide informed consent -
排除标准
- •Have any ongoing disease or ocular condition other than refractive error
- •Have a history of permanent vison loss
- •Have a neurological condition affecting vision
- •Have worn glasses since age 6 or younger
- •Have a prism in their prescription
- •Use Rigid gas permeable lenses or OrthoK lenses
- •Have had laser refractive surgery or any other eye surgery
- •Use prescription eye drops -
结局指标
主要结局
90% Concordance for sphere power and cylinder power (monocular)
时间窗: Baseline
Descriptive statistics for concordance of cylinder axis (monocular) stratified by cylinder power
时间窗: Baseline
Proportion of out-of-range eye that are correctly excluded
时间窗: Baseline
Monocular visual acuity
时间窗: Baseline
Lower confidence limit of ≥95% (for right and left eyes combined)
Incidence of Adverse Events in Part 1
时间窗: 21 days
Incidence of Adverse Events in Part 2
时间窗: 8 Days
Monocular refractive outcomes
时间窗: Baseline
Lower confidence limit of ≥ 90% for concordance (for right and left eyes separately)
次要结局
- Descriptive statistics for monocular and binocular visual acuity (for right and left eyes combined(Baseline)
- Descriptive statistics for cylinder axis (monocular) stratified by cylinder power(Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2))
- Proportion of out of range eyes that are correctly excluded(Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2))
- Comparison of test and re-test measurements to Standard of Care (SOC) data(Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2))
- Rate of disagreement between GoEyes screening at home and in-clinic screening(Baseline)
- Descriptive statistics for concordance of monocular refractive outcomes (for right and left eyes separately(Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2))
- Descriptive statistics for sphere power and cylinder power (monocular)(Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2))