Evaluating and Improving Functional Driving Vision of Patients With Astigmatism

NCT ID: NCT02624791

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-01-31

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)

Conditions

Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lens sequence 1

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

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Group Type: EXPERIMENTAL

1-DAY ACUVUE® MOIST contact lenses

Intervention Type: DEVICE

spherical contact lenses worn during simulated driving tests

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Intervention Type: DEVICE

toric contact lenses worn during simulated driving tests

No contact lenses

Intervention Type: OTHER

simulated driving tests

Lens sequence 2

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

1-DAY ACUVUE® MOIST contact lenses

Group Type: EXPERIMENTAL

1-DAY ACUVUE® MOIST contact lenses

Intervention Type: DEVICE

spherical contact lenses worn during simulated driving tests

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Intervention Type: DEVICE

toric contact lenses worn during simulated driving tests

No contact lenses

Intervention Type: OTHER

simulated driving tests

Lens sequence 3

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

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Group Type: EXPERIMENTAL

1-DAY ACUVUE® MOIST contact lenses

Intervention Type: DEVICE

spherical contact lenses worn during simulated driving tests

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Intervention Type: DEVICE

toric contact lenses worn during simulated driving tests

No contact lenses

Intervention Type: OTHER

simulated driving tests

Lens sequence 4

1-DAY ACUVUE® MOIST contact lenses;

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

Group Type: EXPERIMENTAL

1-DAY ACUVUE® MOIST contact lenses

Intervention Type: DEVICE

spherical contact lenses worn during simulated driving tests

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Intervention Type: DEVICE

toric contact lenses worn during simulated driving tests

No contact lenses

Intervention Type: OTHER

simulated driving tests

Lens sequence 5

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses;

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

Group Type: EXPERIMENTAL

1-DAY ACUVUE® MOIST contact lenses

Intervention Type: DEVICE

spherical contact lenses worn during simulated driving tests

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Intervention Type: DEVICE

toric contact lenses worn during simulated driving tests

No contact lenses

Intervention Type: OTHER

simulated driving tests

Lens sequence 6

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

1-DAY ACUVUE® MOIST contact lenses

Group Type: EXPERIMENTAL

1-DAY ACUVUE® MOIST contact lenses

Intervention Type: DEVICE

spherical contact lenses worn during simulated driving tests

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Intervention Type: DEVICE

toric contact lenses worn during simulated driving tests

No contact lenses

Intervention Type: OTHER

simulated driving tests

Interventions

1-DAY ACUVUE® MOIST contact lenses

spherical contact lenses worn during simulated driving tests

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

toric contact lenses worn during simulated driving tests

Intervention Type: DEVICE

No contact lenses

simulated driving tests

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Daniel Cox, PhD

Professor, Department of Psychiatry and NB Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel J Cox, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Driving Safety Lab

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25946099 (View on PubMed)

Other Identifiers

15920

Identifier Type: -

Identifier Source: org_study_id