Clinical trial NCT01632787: Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria
Official title: Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Binocular Vision Dysfunction
Vertical Heterophoria
Keywords: Anxiety
Binocular
Chronic Headache
Dizziness
Vertical Heterophoria
Vision Dysfunction
Lead sponsor: Vision Specialists of Birmingham
Sponsor class: OTHER
Collaborators: name: Saint Joseph Mercy Health System
First posted: 2012-07-03
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting to the Emergency Department at St. Joseph Mercy Hospital with complaint of non-traumatic exacerbation of chronic headaches of previously unknown etiology.

Brief summary: Patients with acute exacerbation of chronic headache disorder present frequently to the Emergency Department (ED) for pain management. A novel etiology of headaches is Vertical Heterophoria (VH), a poorly understood and little recognized binocular vision malady that when treated with realigning prismatic spectacle lenses results in marked reduction in headache and other associated VH symptoms.

This study aims to determine the accuracy of the Vertical Heterophoria Symptom Questionnaire (VHSQ) in identifying a ED headache patients who will experience significant reduction in VH symptoms with use of realigning prismatic spectacle lenses. This study's secondary purpose is to determine if VH is a common cause of chronic headache disorders in ED headache patients.

To achieve these goals, a prospective observational study will be performed on ED headache patients \> 18 years old. All will be given the VHSQ, and all will be assessed for a diagnosis of VH by an optometrist who will utilize a novel VH testing method. High and low score groups on the VHSQ will then be compared to each other to determine the prevalence of VH in each.


Eligibility criteria: Initially include all patients presenting to Emergency Department with chief complaints of Headache, Head Pain, Face Pain and/or Migraine.

Inclusion Criteria:

* Greater than or equal to 18 years old
* Ability to speak and read English
* Chronic headache disorder as defined by physician diagnosis, or greater than three months of headaches requiring symptom relief with medication more than once every two weeks, or having headaches so severe that previous Emergency Department evaluation or treatment was necessary

Exclusion Criteria:

* Symptoms directly caused by trauma within the last three months
* Known TMJ disorder and presenting with TMJ pain
* Suspected infectious sinusitis or meningitis
* Pain originating from ear
* Pain originating from dental source
* Patient not willing or able to travel to study optometrist for follow-up
* Known history of cerebral aneurysm
* Known history of brain tumor
* Without previous CT, MRI, or other imaging to assess patient's headache disorder
* Patient a prisoner
* Patient under temporary or permanent custodianship
* Patient currently with questionable state of mental competence
* Treating physician or study investigator believes patient to be inappropriate for study participation

Primary outcomes:
measure: VH Diagnosis
timeFrame: 2-4 Weeks
measure: VH Diagnosis
timeFrame: 2-4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomfield Hills
country: United States
facility: Vision Specialists of Michigan
state: Michigan
city: Livonia
country: United States
facility: St. Mary Mercy Hospital
state: Michigan
Study officials:
affiliation: St. Joseph Mercy Hospital
name: Mark S Rosner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vision Specialists of Michigan
name: Debra Feinberg, OD
role: STUDY_DIRECTOR
References: