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| Name | Class |
|---|---|
| Johnson & Johnson Vision Care, Inc. | INDUSTRY |
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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.
Safe driving relies heavily on "good vision." Good vision while driving relates to multiple abilities, such as dynamic visual acuity, contrast sensitivity, management of glare and peripheral vision, etc. While spherical contact lenses address issues of correction of visual acuity as determined by forward static vision tests, if they do not provide visual acuity both immediately and smoothly with eye movement then vision can be compromised. Glare can be a problem as well when contact lenses are off center. Fluctuating vision as a result of lens movement on the eye could be especially problematic and frustrating for patients who have astigmatism. Furthermore, experiencing moments of blurred vision no matter how brief can be potentially hazardous while driving. The 1*DAY ACUVUE® MOIST for ASTIGMATISM contact lenses have a unique blink-activated stabilization system to prevent rotation of the lens on the eye, and may have significant visual advantages for drivers with astigmatism. These lenses provide continuous corrected acuity compared to non-ballasted contact lenses, and thus are potentially safer for driving. Contact comparison will consist of 1*DAY ACUVUE® MOIST (spherical control) versus 1*DAY ACUVUE® MOIST for ASTIGMATISM (the daily disposable astigmatism alternative).
The study will investigate the potential advantages of contact lenses specifically designed to correct for astigmatism, compared to similar correction with spherical contacts, for adult licensed drivers with astigmatism, employing a double-blind (subjects and research assistant blind to hypotheses), randomized, cross-over design (spherical, vs. astigmatism contacts). This will be a multi-stage study comprised of the following:
Preliminary study to determine the likelihood of detecting a significant difference between the standard spherical and astigmatism contacts in a full Randomize Clinical Trial (n=12; data and power analysis)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens sequence 1 | Experimental | No contact lenses; 1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses |
|
| Lens sequence 2 | Experimental | No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses |
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| Lens sequence 3 | Experimental | 1-DAY ACUVUE® MOIST contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses |
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| Lens sequence 4 | Experimental | 1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses |
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| Lens sequence 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-DAY ACUVUE® MOIST contact lenses | Device | spherical contact lenses worn during simulated driving tests |
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| Measure | Description | Time Frame |
|---|---|---|
| Tactical Composite Score | Z-score composite of tactical testing outcomes | 1 day laboratory study |
| Measure | Description | Time Frame |
|---|---|---|
| Operational Composite Score | Z-score composite of operational testing outcomes | 1 day laboratory study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J Cox, Ph.D. | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Driving Safety Lab | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25946099 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens Sequence 1 | None; Sphere; Toric |
| FG001 | Lens Sequence 2 | None; Toric; Sphere |
| FG002 | Lens Sequence 3 | Sphere; None; Toric |
| FG003 | Lens Sequence 4 | Sphere; Toric; None |
| FG004 | Lens Sequence 5 | Toric; None; Sphere |
| FG005 | Lens Sequence 6 | Toric; Sphere; None |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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11 participants completed the operational tests 9 participants completed the tactical tests
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| ID | Title | Description |
|---|---|---|
| BG000 | Contact Lens Sequence | Order in which each participant received the 3 lens conditions |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tactical Composite Score | Z-score composite of tactical testing outcomes | Posted | Mean | Standard Deviation | Z score | 1 day laboratory study |
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1 day
Participants were assessed for Simulation Adaptation Syndrome by using a rating scale after each of their 3 simulated driving periods.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contact Lens Rx | None; Sphere; Toric |
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small number of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Coordinator | UVa Center for Behavioral Medicine Research | 434-924-8656 | tab2v@hscmail.mcc.virginia.edu |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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participants and research assistant blind to hypothesis
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses; No contact lenses |
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| Lens sequence 6 | Experimental | 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST contact lenses |
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| 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses | Device | toric contact lenses worn during simulated driving tests |
|
| No contact lenses | Other | simulated driving tests |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Operational Composite Score | Z-score composite of operational testing outcomes | Posted | Mean | Standard Deviation | Z score | 1 day laboratory study |
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| 0 |
| 11 |
| 0 |
| 11 |
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