Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT00581659
Eligibility Criteria:
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 -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
45 Years
Study:
NCT00581659
Study Brief:
Protocol Section:
NCT00581659