Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3

Astigmatism Clinical Trial

Official title:

Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950545
• Other study ID #: 18499
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: February 1, 2017

Study information

• Verified date: October 2021
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is a common clinical practice to leave small amounts of astigmatism uncorrected in contact lens wearers. Therefore, some drivers who have astigmatism and wear contact lenses may experience blur while driving. The purpose of this study is to determine if correcting small amounts of astigmatism with contact lenses will improve driving safety.

Description:

The purpose of this randomized control trial is to compare visual performance and simulated driving performance of adults with astigmatism when wearing 1*DAY ACUVUE® MOIST for ASTIGMATISM (toric), 1*DAY ACUVUE® MOIST (spherical control), and 1*DAY ACUVUE® MOIST (placebo) contact lenses. Adult subjects with nearsightedness and astigmatism will wear three types of soft contact lenses (placebo, spherical and toric in randomized order). Each subject will read letters on standard eye charts and complete vision and driving tests in a driving simulator. Subjects will repeat these tests with each lens type. Analyses will include an ANOVA to look for a main effect of lens condition, and separate contrasts to compare toric vs. spherical, toric vs. placebo, and spherical vs. placebo lenses. Investigating the lenses under simulated driving conditions, which involve eye movement demands, will lend insight into the potential advantages of toric over spherical contact lenses for driving safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Adult licensed driver

• Ages 18-39 years

• Corrected vision of 20/40 or better in each eye

• Astigmatism between 0.75 and 1.75 diopters in each eye

• Nearsightedness between 0 and -9 diopters in each eye

• No active eye infection

• No defective peripheral vision

• No bifocal correction

• Routinely wears toric contact lenses (more than 4 times per week)

• Routinely drives a car (more than 4 times per week)

• No history of motion, sea, or big screen (e.g. IMAX) sickness, and no persistent Simulation Adaptation Syndrome

Exclusion Criteria:

• Corrected vision worse than 20/40 in either eye

• No astigmatism in either eye

• Active eye infection

• Defective peripheral vision

• Wears bifocals

• Wears contact lenses less than 4 times per week

• Drives infrequently (less than 4 times per week)

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Placebo Lenses
AcuVue Oasys Bandage Lenses with no prescription
• Spherical Lenses
1-DAY ACUVUE® MOIST contact lenses
• Toric Lenses
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Locations

Country	Name	City	State
United States	University of Virginia Driving Safety Laboratory	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tactical Composite Score	This scale measures driving performance in the simulator. It is the sum of the z scores from 15 different driving simulator variables related to braking, steering, speed control and judgment. The scale has no fixed limits. A score of 0 indicates average performance. Higher scores indicate better performance.	1 day
Secondary	Operational Composite Score	This scale measures driving-relevant visual performance. It is the sum of the z scores from 5 different driving simulator variables related to visual testing done in the simulator. The scale has no fixed limits. A score of 0 indicates average performance. Higher scores indicate better performance.	1 day