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Evaluating and Improving Functional Driving Vision of Patients With Astigmatism

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1-DAY ACUVUE® MOIST contact lenses
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
No contact lenses
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring astigmatism, contact lens, driving

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Virginia Driving Safety Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Lens sequence 1

Lens sequence 2

Lens sequence 3

Lens sequence 4

Lens sequence 5

Lens sequence 6

Arm Description

No contact lenses; 1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses

1-DAY ACUVUE® MOIST contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses; No contact lenses

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST contact lenses

Outcomes

Primary Outcome Measures

Tactical Composite Score
Z-score composite of tactical testing outcomes

Secondary Outcome Measures

Operational Composite Score
Z-score composite of operational testing outcomes

Full Information

First Posted
December 30, 2013
Last Updated
February 24, 2020
Sponsor
University of Virginia
Collaborators
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02624791
Brief Title
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
Official Title
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Johnson & Johnson Vision Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
astigmatism, contact lens, driving

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
participants and research assistant blind to hypothesis
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lens sequence 1
Arm Type
Experimental
Arm Description
No contact lenses; 1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Arm Title
Lens sequence 2
Arm Type
Experimental
Arm Description
No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses
Arm Title
Lens sequence 3
Arm Type
Experimental
Arm Description
1-DAY ACUVUE® MOIST contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Arm Title
Lens sequence 4
Arm Type
Experimental
Arm Description
1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses
Arm Title
Lens sequence 5
Arm Type
Experimental
Arm Description
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses; No contact lenses
Arm Title
Lens sequence 6
Arm Type
Experimental
Arm Description
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST contact lenses
Intervention Type
Device
Intervention Name(s)
1-DAY ACUVUE® MOIST contact lenses
Intervention Description
spherical contact lenses worn during simulated driving tests
Intervention Type
Device
Intervention Name(s)
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Intervention Description
toric contact lenses worn during simulated driving tests
Intervention Type
Other
Intervention Name(s)
No contact lenses
Intervention Description
simulated driving tests
Primary Outcome Measure Information:
Title
Tactical Composite Score
Description
Z-score composite of tactical testing outcomes
Time Frame
1 day laboratory study
Secondary Outcome Measure Information:
Title
Operational Composite Score
Description
Z-score composite of operational testing outcomes
Time Frame
1 day laboratory study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Cox, Ph.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Driving Safety Lab
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25946099
Citation
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.
Results Reference
result

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Evaluating and Improving Functional Driving Vision of Patients With Astigmatism

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