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OpenTrials
Completed

NCT Number: NCT02624791

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Driving Safety Lab

Charlottesville, Virginia, 22908, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

1-DAY ACUVUE® MOIST contact lenses

Device

spherical contact lenses worn during simulated driving tests

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Device

toric contact lenses worn during simulated driving tests

No contact lenses

Other

simulated driving tests

Primary outcomes

  1. Tactical Composite Score

    Time frame: 1 day laboratory study

    Z-score composite of tactical testing outcomes

Secondary outcomes

  1. Operational Composite Score

    Time frame: 1 day laboratory study

    Z-score composite of operational testing outcomes

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Johnson & Johnson Vision Care, Inc.

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 8, 2015
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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