Evaluating and Improving Functional Driving Vision of Patients With Astigmatism

Small amounts of astigmatism are often uncorrected in contact lens wearers. The effect with respect to driving is unknown, but it could threaten safe operation of a motor vehicle, especially under conditions such as nighttime driving when visual abilities are highly challenged. This study measures driving-specific visual abilities and simulated driving performance in participants with astigmatism who either have or do not have their astigmatism corrected. The primary hypothesis is that at a tactical level, contact lenses correcting for astigmatism will result in safer driving performance overall. The secondary hypothesis is that at an operational level, contact lenses correcting for astigmatism will result in better driving-specific visual performance.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: 1-DAY ACUVUE® MOIST contact lenses; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; Other: No contact lenses

Detailed Description

Safe driving relies heavily on "good vision." Good vision while driving relates to multiple abilities, such as dynamic visual acuity, contrast sensitivity, management of glare and peripheral vision, etc. While spherical contact lenses address issues of correction of visual acuity as determined by forward static vision tests, if they do not provide visual acuity both immediately and smoothly with eye movement then vision can be compromised. Glare can be a problem as well when contact lenses are off center. Fluctuating vision as a result of lens movement on the eye could be especially problematic and frustrating for patients who have astigmatism. Furthermore, experiencing moments of blurred vision no matter how brief can be potentially hazardous while driving. The 1*DAY ACUVUE® MOIST for ASTIGMATISM contact lenses have a unique blink-activated stabilization system to prevent rotation of the lens on the eye, and may have significant visual advantages for drivers with astigmatism. These lenses provide continuous corrected acuity compared to non-ballasted contact lenses, and thus are potentially safer for driving. Contact comparison will consist of 1*DAY ACUVUE® MOIST (spherical control) versus 1*DAY ACUVUE® MOIST for ASTIGMATISM (the daily disposable astigmatism alternative).

The study will investigate the potential advantages of contact lenses specifically designed to correct for astigmatism, compared to similar correction with spherical contacts, for adult licensed drivers with astigmatism, employing a double-blind (subjects and research assistant blind to hypotheses), randomized, cross-over design (spherical, vs. astigmatism contacts). This will be a multi-stage study comprised of the following:

Preliminary study to determine the likelihood of detecting a significant difference between the standard spherical and astigmatism contacts in a full Randomize Clinical Trial (n=12; data and power analysis)

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Driving Safety Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult licensed drivers between the ages of 18-39, similar number of males and females will be studied who meet the following inclusion criteria:
• Bilateral corrected vision of 20/40 or better
• Bilateral astigmatism between 0.75 to 2.0 diopters, with spherical correction from -1 to -6
• No active eye infection
• No defective peripheral vision
• Do not have correction for bifocals
• Routinely wear contact lenses more than 4 times per week
• Routinely drive a car more than 4 times week
• Do not have a history of motion, sea or big screen (e.g. IMAX) sickness or experience persistent Simulation Adaptation Syndrome

Exclusion Criteria:

• Bilateral corrected vision of worse than 20/40
• No astigmatism
• Active eye infection
• Defective peripheral vision
• Wear bifocals
• Wears contact lenses less than 4 times per week
• Drives infrequently (less than 4 times per week)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens sequence 1; No contact lenses; 1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses	Device: 1-DAY ACUVUE® MOIST contact lenses; spherical contact lenses worn during simulated driving tests; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; toric contact lenses worn during simulated driving tests; Other: No contact lenses; simulated driving tests
Experimental: Lens sequence 2; No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses	Device: 1-DAY ACUVUE® MOIST contact lenses; spherical contact lenses worn during simulated driving tests; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; toric contact lenses worn during simulated driving tests; Other: No contact lenses; simulated driving tests
Experimental: Lens sequence 3; 1-DAY ACUVUE® MOIST contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses	Device: 1-DAY ACUVUE® MOIST contact lenses; spherical contact lenses worn during simulated driving tests; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; toric contact lenses worn during simulated driving tests; Other: No contact lenses; simulated driving tests
Experimental: Lens sequence 4; 1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses	Device: 1-DAY ACUVUE® MOIST contact lenses; spherical contact lenses worn during simulated driving tests; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; toric contact lenses worn during simulated driving tests; Other: No contact lenses; simulated driving tests
Experimental: Lens sequence 5; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses; No contact lenses	Device: 1-DAY ACUVUE® MOIST contact lenses; spherical contact lenses worn during simulated driving tests; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; toric contact lenses worn during simulated driving tests; Other: No contact lenses; simulated driving tests
Experimental: Lens sequence 6; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST contact lenses	Device: 1-DAY ACUVUE® MOIST contact lenses; spherical contact lenses worn during simulated driving tests; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; toric contact lenses worn during simulated driving tests; Other: No contact lenses; simulated driving tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tactical Composite Score	Z-score composite of tactical testing outcomes	1 day laboratory study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operational Composite Score	Z-score composite of operational testing outcomes	1 day laboratory study

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Johnson & Johnson Vision Care, Inc.
• Investigators: Principal Investigator: Daniel J Cox, Ph.D., University of Virginia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: December 30, 2013
• First Submitted That Met QC Criteria: December 4, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: astigmatism, contact lens, driving
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 15920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No