Clinical trial NCT02950545: Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3
Official title: Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Keywords: astigmatism, contact lens, driving
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson Vision Care, Inc.
First posted: 2016-11-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Tactical Composite Score
timeFrame: 1 day
Secondary outcomes:
measure: Operational Composite Score
timeFrame: 1 day
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Driving Safety Laboratory
state: Virginia
Study officials:
affiliation: University of Virginia
name: Daniel J Cox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox DJ, Banton T, Record S, Grabman JH, Hawkins RJ. Does correcting astigmatism with toric lenses improve driving performance? Optom Vis Sci. 2015 Apr;92(4):404-11. doi: 10.1097/OPX.0000000000000554.