Evaluating and Improving Functional Driving Vision of Patients With Astigmatism

• Sponsor: University of Virginia (Other)
• Overall Status: Completed
• CT.gov ID: NCT02624791
• Collaborator: Johnson & Johnson Vision Care, Inc. (Industry)
• Enrollment: 11
• Location: 1
• Arms: 6
• Duration (Months): 4
• Patients Per Site Per Month: 2.7

Study Details

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	N/A

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 1DAY 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 1DAY 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

• Study Type: Interventional
• 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: Sep 1, 2012
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 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

1. Tactical Composite Score [1 day laboratory study]

   Z-score composite of tactical testing outcomes

Secondary Outcome Measures

1. Operational Composite Score [1 day laboratory study]

   Z-score composite of operational testing outcomes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia Driving Safety Lab	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

• University of Virginia
• Johnson & Johnson Vision Care, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Dec 8, 2015
• Last Update Posted: Mar 6, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Daniel Cox, PhD, Professor, Department of Psychiatry and NB Sciences, University of Virginia: astigmatism, contact lens, driving
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Lens Sequence 1	Lens Sequence 2	Lens Sequence 3	Lens Sequence 4	Lens Sequence 5	Lens Sequence 6
Arm/Group Description	None; Sphere; Toric	None; Toric; Sphere	Sphere; None; Toric	Sphere; Toric; None	Toric; None; Sphere	Toric; Sphere; None
Period Title: Overall Study
STARTED	2	1	2	2	2	2
COMPLETED	0	1	2	2	2	2
NOT COMPLETED	2	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Contact Lens Sequence
Arm/Group Description	Order in which each participant received the 3 lens conditions
Overall Participants	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.2 (4.60)
Sex: Female, Male (Count of Participants)
Female	2 18.2%
Male	9 81.8%
Region of Enrollment (participants) [Number]
United States	11 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contact Lens Rx
Arm/Group Description	All study participants
Measure Participants	9
None	-1.73 (3.53)
Sphere	0.19 (2.62)
Toric	1.54 (1.75)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contact Lens Rx
Arm/Group Description	All study participants
Measure Participants	11
None	-2.77 (4.30)
Sphere	1.37 (2.37)
Toric	1.40 (2.65)

Adverse Events

Time Frame	1 day
Adverse Event Reporting Description	Participants were assessed for Simulation Adaptation Syndrome by using a rating scale after each of their 3 simulated driving periods.
Arm/Group Title	Contact Lens Rx
Arm/Group Description	None; Sphere; Toric
All Cause Mortality
	Contact Lens Rx
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Contact Lens Rx
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	Contact Lens Rx
	Affected / at Risk (%)	# Events
Total	0/11 (0%)

Limitations/Caveats

small number of subjects analyzed

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.