Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 39 |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | January 2013 |
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.
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)
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)
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)
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