Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Patient Preference
研究概览
简要总结
At the Aravind Eye Hospital (AEH) in Madurai, India, patients ages 18-40 receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and objective refraction, by way of the QuickSee autorefractor. Patients will then be randomized into one of two treatment plans: receive glasses from objective measure first then subjective measure 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 double 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants-
- •who visit a Vision Center for their eye check-up
- •who are aged between 18 years and 40 years
排除标准
- •Participants-
- •whose refractive error is not within the detection range of the QuickSee device: -10 to +10 D
- •who have a cylindrical power greater than 3 D
- •who have to travel long distances (beyond 10kms) to the hospital
- •who choose to buy spectacles that are priced more than Rs. 2000/- per pair
- •who have speech or hearing impairment
- •who do not speak the local language, Tamil
- •who do not want to purchase spectacles from AEH
结局指标
主要结局
Patient Preference
时间窗: 2 years
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