Clinical Trial: Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3

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 Summary: 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.
Sponsor: University of Virginia

Current Primary Outcome: Tactical Composite Score [ Time Frame: 1 day ]

Driving performance


Original Primary Outcome: Same as current

Current Secondary Outcome: Operational Composite Score [ Time Frame: 1 day ]

Driving-relevant visual performance


Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: October 28, 2016
Date Started: April 2016
Date Completion:
Last Updated: October 28, 2016
Last Verified: October 2016