N/A
N=11
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT02624791 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Tactical Composite Score — -1.73; 0.19; 1.54 Z score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 1-DAY ACUVUE® MOIST contact lenses (Device); 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses (Device); No contact lenses (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tactical Composite Score |
-1.73; 0.19; 1.54 | — |
| SECONDARY Operational Composite Score |
-2.77; 1.37; 1.40 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02624791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.