Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Tactical Composite Score
研究概览
简要总结
Small amounts of astigmatism are often uncorrected in contact lens wearers. The effect with respect to driving is unknown, but it could threaten safe operation of a motor vehicle, especially under conditions such as nighttime driving when visual abilities are highly challenged. This study measures driving-specific visual abilities and simulated driving performance in participants with astigmatism who either have or do not have their astigmatism corrected. The primary hypothesis is that at a tactical level, contact lenses correcting for astigmatism will result in safer driving performance overall. The secondary hypothesis is that at an operational level, contact lenses correcting for astigmatism will result in better driving-specific visual performance.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
participants and research assistant blind to hypothesis
入排标准
- 年龄范围
- 18 Years 至 39 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Tactical Composite Score
时间窗: 1 day laboratory study
Z-score composite of tactical testing outcomes
次要结局
- Operational Composite Score(1 day laboratory study)
研究者
Daniel Cox, PhD
Professor, Department of Psychiatry and NB Sciences
University of Virginia
