A Prospective Clinical Study to Evaluate the Effectiveness of Digital Refraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Visibly
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- A digital refraction will be compared to standard manual refraction methods (using a phoropter) to the correlation of the two methods.
研究概览
简要总结
Prospective, comparative, randomized, non-masked clinical study to compare the a digital refraction with LogMAR VA testing utilizing trial lenses, to standard manual refraction using a Phoropter, and LogMAR VA testing, in accuracy of visual acuity measurement.
详细描述
A digital refraction tool is a device meant to measure visual acuity and to subjectively measure refractive value for a patient's eye for the conditions of myopia and astigmatism. It is intended for adults aged 22 to 55 years that have no prior correction with up to 3.00 diopters (D) of myopia and up to 2.00 D of astigmatism, or those with prior correction up to 10.00 D of myopia and require an over-refraction of no more than 2.75 D.
LogMAR (ETDRS) chart to measure visual acuity.
The manual manifest refraction is performed by an eyecare specialist using a phoropter.
The LogMAR Visual Acuity chart is used to measure visual acuity. The manual refraction will be used in this study for obtaining the refractive error of each eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be between 22 and 55 years of age at the time of consent.
- •Subject must have a refractive error
- •With no greater than -3.00 D myopia and -2.00 D astigmatism in either eye.
- •With prior correction of no greater than -10.00 D myopia and requiring over-refraction of no more than 2.75 D in either eye.
- •Subjects with Best Corrected Visual Acuity (BCVA) of 20/32 or better.
排除标准
- •Subjects with diabetes mellitus.
- •Subjects using ophthalmic or systemic corticosteroids.
- •Subjects with autoimmune conditions.
- •Subjects with active corneal or conjunctival infection.
- •Subjects with active corneal, conjunctival, or intraocular inflammation (ie, uveitis).
- •Subjects with diabetic retinopathy.
- •Subjects with glaucoma or ocular hypertension.
- •Subjects with macular degeneration.
- •Subjects with previous ocular surgery.
- •Subjects on antihyperglycemic agents; corticosteroids; hydroxychloroquine (Plaquenil) and chloroquine (Aralen); tamoxifen (Nolvadex).
- •Subjects who, in the judgment of the Investigator, may be inappropriate for the intended study procedures.
研究组 & 干预措施
Digital refraction
Web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone
干预措施: Manual Refraction (Other)
Manual Refraction
Manual manifest refraction is performed by an eyesore specialist using a phoropter.
干预措施: Digital refraction (Device)
结局指标
主要结局
A digital refraction will be compared to standard manual refraction methods (using a phoropter) to the correlation of the two methods.
时间窗: After the Day 1 Visits
The difference between testing methods (Manual Refraction with a phoropter versus a digital refraction test) will be analyzed by mean, standard deviation, and 95% confidence interval overall and by the levels of refractive correction (sphere, cylinder, MRSE) and for visual acuity using LogMAR format.
次要结局
未报告次要终点