Direct Comparison of SVOne Obtained Refraction to Subjective Manifest Refraction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sphere, cylinder and axis measurement for each patient
研究概览
简要总结
The purpose of the study is to compare the final glasses prescription based on refraction obtained with SVOne device to the final prescription obtained via subjective manifest refraction.
详细描述
Uncorrected refractive error is the leading cause of vision impairment and the second leading cause of blindness worldwide, affecting 1 in 90 individuals (1). In the US population approximately 14 million individuals aged 12 years or older have visual impairment (defined as distance visual acuity of 20/50 or worse), of which more than 11 million individuals (2) could have their vision improved to 20/40 or better with refractive correction.
Uncorrected refractive error impacts all aspects of life, including, but not limited to, loss of employment opportunities, inability to care for family, and inability to receive an education. SVOne is smartphone-based autorefractor, powered by wavefront aberrometry, due to its portability and accuracy it presents as an effective and accessible method of detecting refractive error and dispensing spectacles for better vision (3).
In this study, for each patient, a single clinician will determine final prescription through manifest refraction, while a different clinician will determine final prescription using SVOne exam protocol. Sphere, cylinder and axis will be converted to power vectors and compared by linear regression analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be 12 (under 18 with parental consent) years of age and older up to 65 years of age.
- •No known ocular pathology from previous clinical exams that may limit best corrected visual acuity.
排除标准
- •Refractive error greater than +/- 14.00 diopters, or astigmatism greater than -7.00 diopters.
- •Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit BCVA.
- •Best corrected visual acuity with spectacles of 20/25 or worse.
- •Any previous surgical or laser procedures that may limit BCVA
- •11 years of age and younger
结局指标
主要结局
Sphere, cylinder and axis measurement for each patient
时间窗: 4 months
the outcome includes sphere, cylinder and axis measurement (in diopter) by using both SVOne wave-guided autorefractor and subjective manifest refraction
Comparison of two measurements on the same patient
时间窗: 4 months
the outcome will include comparison of two sphere, cylinder and axis measurements (in power vectors) for each patient obtained with SVOne wave-guided autorefractor and subjective manifest refraction.
次要结局
未报告次要终点