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

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses

• Registration Number: NCT02950545
• Lead Sponsor: University of Virginia

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-11-01
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Results First Submitted: 2019-05-09
• Results First Submitted QC: 2020-04-13
• Results First Posted: 2020-04-21
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Spherical, Placebo, then Toric Lenses	Placebo Lenses	Crossover order 3
Spherical, Placebo, then Toric Lenses	Toric Lenses	Crossover order 3
Spherical, Toric, then Placebo Lenses	Toric Lenses	Crossover order 4
Toric, Spherical, then Placebo Lenses	Placebo Lenses	Crossover order 6
Placebo, Toric, then Spherical Lenses	Spherical Lenses	Crossover order 2
Spherical, Placebo, then Toric Lenses	Spherical Lenses	Crossover order 3
Toric, Placebo, then Spherical Lenses	Placebo Lenses	Crossover order 5
Spherical, Toric, then Placebo Lenses	Placebo Lenses	Crossover order 4
Spherical, Toric, then Placebo Lenses	Spherical Lenses	Crossover order 4
Toric, Spherical, then Placebo Lenses	Spherical Lenses	Crossover order 6
Placebo, Spherical, then Toric Lenses	Placebo Lenses	Crossover order 1
Placebo, Spherical, then Toric Lenses	Spherical Lenses	Crossover order 1
Placebo, Spherical, then Toric Lenses	Toric Lenses	Crossover order 1
Placebo, Toric, then Spherical Lenses	Placebo Lenses	Crossover order 2
Placebo, Toric, then Spherical Lenses	Toric Lenses	Crossover order 2
Toric, Placebo, then Spherical Lenses	Spherical Lenses	Crossover order 5
Toric, Placebo, then Spherical Lenses	Toric Lenses	Crossover order 5
Toric, Spherical, then Placebo Lenses	Toric Lenses	Crossover order 6

Primary Outcome Measures

Name	Time	Method
Tactical Composite Score	1 day	This scale measures driving performance in the simulator. It is the sum of the z scores from 15 different driving simulator variables related to braking, steering, speed control and judgment. The scale has no fixed limits. A score of 0 indicates average performance. Higher scores indicate better performance.

Secondary Outcome Measures

Name	Time	Method
Operational Composite Score	1 day	This scale measures driving-relevant visual performance. It is the sum of the z scores from 5 different driving simulator variables related to visual testing done in the simulator. The scale has no fixed limits. A score of 0 indicates average performance. Higher scores indicate better performance.

Trial Locations

Locations (1)

University of Virginia Driving Safety Laboratory; 🇺🇸 Charlottesville, Virginia, United States