Astigmatism Clinical Trial
Official title:
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
NCT number | NCT02624791 |
Other study ID # | 15920 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | January 2013 |
Verified date | February 2020 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 39 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia Driving Safety Lab | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | Johnson & Johnson Vision Care, Inc. |
United States,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tactical Composite Score | Z-score composite of tactical testing outcomes | 1 day laboratory study | |
Secondary | Operational Composite Score | Z-score composite of operational testing outcomes | 1 day laboratory study |
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