Evaluating and Improving Functional Driving Vision of Patients With Astigmatism

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ClinicalTrials.gov Identifier: NCT02624791

Recruitment Status : Completed

First Posted : December 8, 2015

Results First Posted : May 23, 2017

Last Update Posted : March 6, 2020

Sponsor:

Collaborator:

Johnson & Johnson Vision Care, Inc.

Information provided by (Responsible Party):

Daniel Cox, PhD, University of Virginia

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Astigmatism	Device: 1-DAY ACUVUE® MOIST contact lenses Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses Other: No contact lenses	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	11 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Masking Description:	participants and research assistant blind to hypothesis
Primary Purpose:	Treatment
Official Title:	Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
Study Start Date :	September 2012
Actual Primary Completion Date :	January 2013
Actual Study Completion Date :	January 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Tactical Composite Score [ Time Frame: 1 day laboratory study ]
Z-score composite of tactical testing outcomes

Secondary Outcome Measures :

Operational Composite Score [ Time Frame: 1 day laboratory study ]
Z-score composite of operational testing outcomes

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 39 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624791

Locations

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

Sponsors and Collaborators

University of Virginia

Johnson & Johnson Vision Care, Inc.

Investigators

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Principal Investigator:	Daniel J Cox, Ph.D.	University of Virginia

More Information

Publications of Results:

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.

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Responsible Party:	Daniel Cox, PhD, Professor, Department of Psychiatry and NB Sciences, University of Virginia
ClinicalTrials.gov Identifier:	NCT02624791
Other Study ID Numbers:	15920
First Posted:	December 8, 2015 Key Record Dates
Results First Posted:	May 23, 2017
Last Update Posted:	March 6, 2020
Last Verified:	February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Daniel Cox, PhD, University of Virginia:


astigmatism, contact lens, driving

Additional relevant MeSH terms:

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Astigmatism Refractive Errors Eye Diseases

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