NCT02950545

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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.

Conditions

• Astigmatism

Interventions

Type	Name	Description
DEVICE	Placebo Lenses	AcuVue Oasys Bandage Lenses with no prescription
DEVICE	Spherical Lenses	1-DAY ACUVUE® MOIST contact lenses
DEVICE	Toric Lenses	1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-11-01
• Last updated: 2021-10-06
• Results posted: 2020-04-21

Locations

1 site across 1 country: United States