Evaluating and Improving Functional Driving Vision of Patients With Astigmatism

NCT02624791 | Completed Results

• 1 other identifier: 15920
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism

Keywords

astigmatism, contact lens, driving

Outcome Measures

Primary Outcomes (1)

• Tactical Composite Score

  Z-score composite of tactical testing outcomes

  1 day laboratory study

Secondary Outcomes (1)

• Operational Composite Score

  1 day laboratory study

Study Arms (6)

Lens sequence 1

EXPERIMENTAL

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

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

Lens sequence 2

EXPERIMENTAL

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

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

Lens sequence 3

EXPERIMENTAL

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

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

Lens sequence 4

EXPERIMENTAL

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

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

Lens sequence 5

EXPERIMENTAL

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

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

Lens sequence 6

EXPERIMENTAL

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

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

Interventions

1-DAY ACUVUE® MOIST contact lenses DEVICE

spherical contact lenses worn during simulated driving tests

Lens sequence 1; Lens sequence 2; Lens sequence 3; Lens sequence 4; Lens sequence 5; Lens sequence 6

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses DEVICE

toric contact lenses worn during simulated driving tests

Lens sequence 1; Lens sequence 2; Lens sequence 3; Lens sequence 4; Lens sequence 5; Lens sequence 6

No contact lenses OTHER

simulated driving tests

Lens sequence 1; Lens sequence 2; Lens sequence 3; Lens sequence 4; Lens sequence 5; Lens sequence 6

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Virginia: lead
• Johnson & Johnson Vision Care, Inc.: collaborator

Study Sites (1)

University of Virginia Driving Safety Lab

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• 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.

  PMID: 25946099 RESULT

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

small number of subjects analyzed

Results Point of Contact

• Title: Project Coordinator
• Organization: UVa Center for Behavioral Medicine Research

tab2v@hscmail.mcc.virginia.edu

434-924-8656

Study Officials

• Daniel J Cox, Ph.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: participants and research assistant blind to hypothesis
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry and NB Sciences

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: December 8, 2015
• Study Start: September 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 6, 2020
• Results First Posted: May 23, 2017

Record last verified: 2020-02

Locations

US (1)