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

University of Virginia

Status: Completed

Conditions: Astigmatism

Treatments: Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02950545

18499

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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51 participants in 6 patient groups

Placebo, Spherical, then Toric Lenses

Experimental group

Description:

Crossover order 1

Treatment:

Device: Spherical Lenses

Device: Placebo Lenses

Device: Toric Lenses

Placebo, Toric, then Spherical Lenses

Experimental group

Description:

Crossover order 2

Treatment:

Device: Spherical Lenses

Device: Placebo Lenses

Device: Toric Lenses

Spherical, Placebo, then Toric Lenses

Experimental group

Description:

Crossover order 3

Treatment:

Device: Spherical Lenses

Device: Placebo Lenses

Device: Toric Lenses

Spherical, Toric, then Placebo Lenses

Experimental group

Description:

Crossover order 4

Treatment:

Device: Spherical Lenses

Device: Placebo Lenses

Device: Toric Lenses

Toric, Placebo, then Spherical Lenses

Experimental group

Description:

Crossover order 5

Treatment:

Device: Spherical Lenses

Device: Placebo Lenses

Device: Toric Lenses

Toric, Spherical, then Placebo Lenses

Experimental group

Description:

Crossover order 6

Treatment:

Device: Spherical Lenses

Device: Placebo Lenses

Device: Toric Lenses