Clinical trial NCT00785135: Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria
Official title: Effects of Vertical Prism on the Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria: A Randomized, Double-blinded, Placebo-controlled, Cross-over Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Binocular Dysfunction
Vertical Heterophoria
Vision, Binocular
Vision Disparity
Keywords: vision, binocular
vision disparity
headache
dizziness
anxiety
neck pain
learning disorders
asthenopia
motion sickness
depth perception
gait disorder
diplopia
photophobia
agoraphobia
panic disorder
Lead sponsor: Vision Specialists of Birmingham
Sponsor class: OTHER
Collaborators: name: Essilor International
First posted: 2008-11-05
Enrollment: 13
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 correction called vertical prism is added to the patient's normal eye glass prescription.

The experiment will involve giving the patient two pairs of glasses (one pair containing the baseline prescription with vertical prism (Standard Treatment Glasses) and the other pair containing the baseline prescription but without vertical prism (Placebo Glasses)) to demonstrate which pair of glasses is most effective in reducing the symptoms of dizziness, headache and / or anxiety in these patients.


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

Primary outcomes:
measure: Evidence of change / improvement of symptoms of headache, dizziness and anxiety as demonstrated by validated, self-administered survey tools for these symptoms
timeFrame: Survey tools administered at baseline, 5-7 days after wearing the first pair of glasses, 5-7 days after wearing the second pair of glasses, and when treatment is completed
Secondary outcomes:
measure: Evidence that a new survey tool developed by the authors to assess changes / improvement in dizziness, headache and anxiety associated with Vertical Heterophoria correlates to validated, self-administered survey tools for these same symptoms
timeFrame: New survey tool to be administered at baseline, 5-7 days after wearing the first pair of glasses, 5-7 days after wearing the second pair of glasses, and when treatment is completed
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Vision Specialists of Birmingham
state: Michigan
Study officials:
affiliation: Vision Specialists of Birmingham
name: Mark S Rosner, MD
role: PRINCIPAL_INVESTIGATOR
References: