Status:
TERMINATED
Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria
Lead Sponsor:
Vision Specialists of Birmingham
Collaborating Sponsors:
Essilor International
Conditions:
Binocular Dysfunction
Vertical Heterophoria
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate whether, in patients diagnosed with Vertical Heterophoria, the symptoms of dizziness, headache and / or anxiety are reduced or eliminated when a kind of cor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00785135
Start Date
November 1 2008
End Date
November 1 2015
Last Update
October 12 2020
Active Locations (1)
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1
Vision Specialists of Birmingham
Birmingham, Michigan, United States, 48009