An Evaluation of the LFR-260 Against a Traditional Phoropter in Visual Acuity Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 4
- 主要终点
- Effectiveness of LFR260 on Visual Acuity Test
研究概览
简要总结
The purpose of this study is to establish if LFR-260 (investigational device) is not inferior in effectiveness to a traditional phoropter (control device) when applied in visual acuity test in subjects undergoing a full routine eye examination. LFR-260 proposes to provide information of the visual capabilities of the patient. The test will be provided and supervised by a qualified eye care provider. The informed consent, screening, randomization (into the order of visual test device used), (visual) device testing (to include precision testing, remote and offsite testing) will all occur at a single visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
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
- •The participant or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.
- •The participant is a male or female between the ages of 12 and 65 (inclusive).
- •The participant has no more than mild to moderate far-sightedness, near-sightedness, astigmatism or anisometropia.
- •The participant is free of ocular and systemic abnormalities that might affect visual functions.
排除标准
- •The participant has diabetes mellitus (Type 1 or 2).
- •The participant has an autoimmune condition.
- •The participant is pregnant (self-reported).
- •The participant has an active corneal or conjunctival infection.
- •The participant has an active corneal, conjunctival, or intraocular inflammation (i.e. - uveitis).
- •The participant has diabetic retinopathy.
- •The participant has glaucoma or ocular hypertension.
- •The participant has macular degeneration.
- •The participant has had a previous ocular surgery.
- •The participant has ocular and systemic diseases or abnormalities that might affect visual functions.
- •The participant has a history of amblyopia, strabismus, or any other binocular vision abnormality.
- •The participant has a history of AMD (age macular degeneration).
- •The participant is a prisoner, a transient or has been treated for alcohol and/or drug abuse in an inpatient substance abuse program within 6 months prior to proposed study enrolment.
- •The participant will not be able to complete questionnaires.
- •The participant is currently in an investigational study for a similar purpose.
- •The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures.
结局指标
主要结局
Effectiveness of LFR260 on Visual Acuity Test
时间窗: Day 0
Agreement of LFR-260 (investigational device) to traditional phoropter (comparator device) when applied in visual acuity test (eye chart test) in subjects undergoing a full routine eye examination. Agreement will be determined by demonstrating that the LFR-260 is within 0.5D (+/-) in measuring sphere and cylinder results and within 10 degrees for axis results among subjects with low astigmatism and within 5 degrees among subjects with moderate to high astigmatism from the traditional phoropter.
Precision of LFR260 in Repeated Testing
时间窗: Day 0
Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260.
次要结局
- Patient Satisfaction Survey(Day 0)
- Provider Satisfaction Survey(Day 0)