Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
研究概览
地位
条件
详细说明
Safe driving relies heavily on "good vision." Good vision while driving relates to multiple abilities, such as dynamic visual acuity, contrast sensitivity, management of glare and peripheral vision, etc. While spherical contact lenses address issues of correction of visual acuity as determined by forward static vision tests, if they do not provide visual acuity both immediately and smoothly with eye movement then vision can be compromised. Glare can be a problem as well when contact lenses are off center. Fluctuating vision as a result of lens movement on the eye could be especially problematic and frustrating for patients who have astigmatism. Furthermore, experiencing moments of blurred vision no matter how brief can be potentially hazardous while driving. The 1*DAY ACUVUE® MOIST for ASTIGMATISM contact lenses have a unique blink-activated stabilization system to prevent rotation of the lens on the eye, and may have significant visual advantages for drivers with astigmatism. These lenses provide continuous corrected acuity compared to non-ballasted contact lenses, and thus are potentially safer for driving. Contact comparison will consist of 1*DAY ACUVUE® MOIST (spherical control) versus 1*DAY ACUVUE® MOIST for ASTIGMATISM (the daily disposable astigmatism alternative).
The study will investigate the potential advantages of contact lenses specifically designed to correct for astigmatism, compared to similar correction with spherical contacts, for adult licensed drivers with astigmatism, employing a double-blind (subjects and research assistant blind to hypotheses), randomized, cross-over design (spherical, vs. astigmatism contacts). This will be a multi-stage study comprised of the following:
Preliminary study to determine the likelihood of detecting a significant difference between the standard spherical and astigmatism contacts in a full Randomize Clinical Trial (n=12; data and power analysis)
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
Virginia
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Charlottesville、Virginia、美国、22908
- University of Virginia Driving Safety Lab
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult licensed drivers between the ages of 18-39, similar number of males and females will be studied who meet the following inclusion criteria:
- Bilateral corrected vision of 20/40 or better
- Bilateral astigmatism between 0.75 to 2.0 diopters, with spherical correction from -1 to -6
- No active eye infection
- No defective peripheral vision
- Do not have correction for bifocals
- Routinely wear contact lenses more than 4 times per week
- Routinely drive a car more than 4 times week
- Do not have a history of motion, sea or big screen (e.g. IMAX) sickness or experience persistent Simulation Adaptation Syndrome
Exclusion Criteria:
- Bilateral corrected vision of worse than 20/40
- No astigmatism
- Active eye infection
- Defective peripheral vision
- Wear bifocals
- Wears contact lenses less than 4 times per week
- Drives infrequently (less than 4 times per week)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Lens sequence 1
No contact lenses; 1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses |
spherical contact lenses worn during simulated driving tests
toric contact lenses worn during simulated driving tests
simulated driving tests
|
|
实验性的:Lens sequence 2
No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses |
spherical contact lenses worn during simulated driving tests
toric contact lenses worn during simulated driving tests
simulated driving tests
|
|
实验性的:Lens sequence 3
1-DAY ACUVUE® MOIST contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses |
spherical contact lenses worn during simulated driving tests
toric contact lenses worn during simulated driving tests
simulated driving tests
|
|
实验性的:Lens sequence 4
1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses |
spherical contact lenses worn during simulated driving tests
toric contact lenses worn during simulated driving tests
simulated driving tests
|
|
实验性的:Lens sequence 5
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses; No contact lenses |
spherical contact lenses worn during simulated driving tests
toric contact lenses worn during simulated driving tests
simulated driving tests
|
|
实验性的:Lens sequence 6
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST contact lenses |
spherical contact lenses worn during simulated driving tests
toric contact lenses worn during simulated driving tests
simulated driving tests
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Tactical Composite Score
大体时间:1 day laboratory study
|
Z-score composite of tactical testing outcomes
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1 day laboratory study
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Operational Composite Score
大体时间:1 day laboratory study
|
Z-score composite of operational testing outcomes
|
1 day laboratory study
|
合作者和调查者
调查人员
- 首席研究员:Daniel J Cox, Ph.D.、University of Virginia
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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