Astigmatism Clinical Trial
Official title:
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
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.
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)
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