N/A
N=51
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT02950545 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Tactical Composite Score — 0.34; -0.01; -0.33 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Placebo Lenses (Device); Spherical Lenses (Device); Toric Lenses (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tactical Composite Score |
0.34; -0.01; -0.33 | — |
| SECONDARY Operational Composite Score |
-4.06; 2.01; 2.05 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02950545). 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.