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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT00785135
Eligibility Criteria:
Inclusion Criteria:
* First time appointment for a patient at designated optometry office for treatment of symptoms associated with Vertical Heterophoria
* Must have symptoms of dizziness or headache or both:
* Dizziness defined as one or more of these: lightheadedness,dizziness, vertigo, feeling off-balance, lack of coordination / "clumsy", unsteadiness while walking or drifting / veering to one side while walking, motion sickness
* Headache defined as one or more of these: pain anywhere in the head,posterior neck / upper trapezius (upper back), face, and in and / or around the eyes
* Duration of symptoms greater than 4 months
* Evaluated for these symptoms previously by at least 1 other doctor (General Practice, Family Practice, Internal Medicine, Neurology, ENT, Emergency Medicine, Pediatrics, PM\&R, Ophthalmology).
* Age \>14
* The patient (or their representative) must be able and willing to fill out extra paperwork
* All Patients to be seen by same Optometrist for all visits
* Must be willing to wear glasses.
* The patient (or their representative) must be able to sign informed consent
* Must have a driver for Follow Up visits where Control and Treatment Glasses are dispensed, and when Washout period is initiated
* Must have a driver for Follow Up visits where Control and Treatment Glasses are dispensed, and when Washout period is initiated
* Must have previous negative Neuroimaging (HCT or MRI) that was ordered to assess for headache and / or dizziness
Exclusion Criteria:
* Previous diagnosis of strabismus, vertical heterotropia, CN 3, 4 or 6 palsy, "lazy eye"
* Previous eye injury or eye operation (including RK and Lasik)
* Diagnosis of glaucoma
* Diagnosis of cataracts
* Diagnosis of proptosis
* Previous C-spine surgery / fusion
* Previous Rx contains prismatic correction
* \>18 PD of exophoria
* \> 4 PD of vertical heterophoria on Initial Exam
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT00785135
Study Brief:
Protocol Section:
NCT00785135