Astigmatism Clinical Trial
Official title:
Evaluation of the Bausch & Lomb PureVision Under Nighttime Driving Conditions
Verified date | April 2017 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of this study is to quantify differences in nighttime driving performance
between the Bausch & Lomb PureVision™ aspheric contact lenses and a conventional spherical
contact lens.
The primary aims of this study are to determine the differences between B&L PureVision™
aspheric contact lenses and a conventional spherical contact lens in visual performance
measures associated with driving, such as number of objects seen.
The secondary aims of this study are to determine differences between B&L PureVision™
aspheric contact lenses and a conventional spherical contact lens in driving performance
measures such as number of objects hit.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 45 Years |
Eligibility |
Inclusion Criteria: Inclusion Criteria - valid US driver's license - drive at least 100 miles per month - not restricted to driving at night - willing to travel to the National Advanced Driving Simulator - currently successfully wear soft spherical contact lenses - between the ages of 25 and 45 - no previous participation in any vision simulator driving studies Exclusion Criteria: Exclusion Criteria - known or suspected pregnancy - current serious illness or have received radiation and/or chemotherapy treatment within the last 6 months - Type 1 Diabetics or Untreated Type II Diabetics - current heart condition or heart attack, or pacemaker implanted within last 6 months - known seizure disorder or epilepsy - Meniere's disease or any inner ear, vertigo, hearing, or balance conditions - known narcolepsy - Chronic Fatigue Syndrome - untreated sleep apnea - uncontrolled asthma or chronic bronchitis - Chronic Obstructive Pulmonary Disease - migraine headaches that require narcotic medications - untreated depression or anxiety disorder - claustrophobia - drug dependency - untreated ADHD - taking current prescription or over-the-counter medications that create sedation or drowsiness - uncontrolled glaucoma or glaucoma under current treatment - propensity toward motion sickness - new diagnosis of dementia by physician - diagnosis of macular degeneration - experience any side effects from dilation of the eyes - Diabetes-induced eye disease in either eye - Cataract surgery in either eye or currently have cataracts - refractive eye surgery in either eye - more than 0.25 diopters of refractive astigmatism in either eye - less than 0.05 microns of positive spherical aberration in either eye -refractive error less than -0.50 diopters or greater than -3.00 diopters - |
Country | Name | City | State |
---|---|---|---|
United States | National Advanced Driving Simulator | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
University of Iowa | Bausch & Lomb Incorporated |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint measured is the number of objects on the roadway that were detected - a count of the total number of objects that the driver correctly detects out of the total number of objects present. | at time of both drives | ||
Secondary | The secondary aims of this study are to determine differences between B&L PureVision™ aspheric contact lenses and a conventional spherical contact lens in driving performance measures such as number of objects hit. | at the time of both drives |
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