Validation of the QuickSee Plus Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Patient Preference
研究概览
简要总结
At the New England College of Optometry in Boston, MA, subjects ages 18-65 who have received or are receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and automated refraction, by way of the QuickSee Plus refractor. Subjects will then be randomized into one of two treatment plans: receive glasses from automated refraction first then subjective refraction second, and vice versa. After one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. After a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. Patients may then decide which pair patient like best. This is a triple blind, case-crossover clinical trial.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •who have had an eye exam at the NECO Center for Eye Care of Commonwealth or Roslindale
- •who are aged between 18 years and 65 years
排除标准
- •whose refractive error is outside of the detection range of the QuickSee Free Pro and QuickSee Plus devices: -13 D to +10 D (S) and -8 D to + 8 D (C)
- •who are unable to provide consent
- •who have undergone any eye surgery
- •who have a history of ocular disease
- •who are taking systemic drugs
- •who wear more than one pair of single vision eyeglasses for distance
- •who more than occasionally wear soft contact lenses
- •who are unable and unwilling to wear the eyeglasses provided by the study for the required duration
结局指标
主要结局
Patient Preference
时间窗: 2 weeks
Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.
次要结局
未报告次要终点
研究者
Shivang R. Dave, PhD
CEO & co-founder
PlenOptika, Inc.