Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 39 |
| Updated: | 10/28/2017 |
| Start Date: | April 2016 |
| End Date: | February 1, 2017 |
It is a common clinical practice to leave small amounts of astigmatism uncorrected in contact
lens wearers. Therefore, some drivers who have astigmatism and wear contact lenses may
experience blur while driving. The purpose of this study is to determine if correcting small
amounts of astigmatism with contact lenses will improve driving safety.
lens wearers. Therefore, some drivers who have astigmatism and wear contact lenses may
experience blur while driving. The purpose of this study is to determine if correcting small
amounts of astigmatism with contact lenses will improve driving safety.
The purpose of this randomized control trial is to compare visual performance and simulated
driving performance of adults with astigmatism when wearing 1*DAY ACUVUE® MOIST for
ASTIGMATISM (toric), 1*DAY ACUVUE® MOIST (spherical control), and 1*DAY ACUVUE® MOIST
(placebo) contact lenses. Adult subjects with nearsightedness and astigmatism will wear three
types of soft contact lenses (placebo, spherical and toric in randomized order). Each subject
will read letters on standard eye charts and complete vision and driving tests in a driving
simulator. Subjects will repeat these tests with each lens type. Analyses will include an
ANOVA to look for a main effect of lens condition, and separate contrasts to compare toric
vs. spherical, toric vs. placebo, and spherical vs. placebo lenses. Investigating the lenses
under simulated driving conditions, which involve eye movement demands, will lend insight
into the potential advantages of toric over spherical contact lenses for driving safety.
driving performance of adults with astigmatism when wearing 1*DAY ACUVUE® MOIST for
ASTIGMATISM (toric), 1*DAY ACUVUE® MOIST (spherical control), and 1*DAY ACUVUE® MOIST
(placebo) contact lenses. Adult subjects with nearsightedness and astigmatism will wear three
types of soft contact lenses (placebo, spherical and toric in randomized order). Each subject
will read letters on standard eye charts and complete vision and driving tests in a driving
simulator. Subjects will repeat these tests with each lens type. Analyses will include an
ANOVA to look for a main effect of lens condition, and separate contrasts to compare toric
vs. spherical, toric vs. placebo, and spherical vs. placebo lenses. Investigating the lenses
under simulated driving conditions, which involve eye movement demands, will lend insight
into the potential advantages of toric over spherical contact lenses for driving safety.
Inclusion Criteria:
- Adult licensed driver
- Ages 18-39 years
- Corrected vision of 20/40 or better in each eye
- Astigmatism between 0.75 and 1.75 diopters in each eye
- Nearsightedness between 0 and -9 diopters in each eye
- No active eye infection
- No defective peripheral vision
- No bifocal correction
- Routinely wears toric contact lenses (more than 4 times per week)
- Routinely drives a car (more than 4 times per week)
- No history of motion, sea, or big screen (e.g. IMAX) sickness, and no persistent
Simulation Adaptation Syndrome
Exclusion Criteria:
- Corrected vision worse than 20/40 in either eye
- No astigmatism in either eye
- Active eye infection
- Defective peripheral vision
- Wears bifocals
- Wears contact lenses less than 4 times per week
- Drives infrequently (less than 4 times per week)
We found this trial at
1
site
Click here to add this to my saved trials
