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Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria (VH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01632787
First Posted: July 3, 2012
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Saint Joseph Mercy Health System
Information provided by (Responsible Party):
Vision Specialists of Birmingham
  Purpose

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.


Condition Intervention
Binocular Vision Dysfunction Vertical Heterophoria Other: Questionnaires and Optometrist Prism Challenge/Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria

Resource links provided by NLM:


Further study details as provided by Vision Specialists of Birmingham:

Primary Outcome Measures:
  • VH Diagnosis [ Time Frame: 2-4 Weeks ]
    Significant reduction of symptom burden as reflected on follow-up Severity Index (SI) score with prismatic spectacle challenge and treatment.

  • VH Diagnosis [ Time Frame: 2-4 Weeks ]
    Significant reduction of symptom burden as reflected on follow-up Vertical Heterophoria Symptom Questionnaire (VHSQ) score with prismatic spectacle challenge and treatment.


Enrollment: 86
Study Start Date: April 2012
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Questionnaires and Optometrist Prism Challenge/Treatment
    A Vertical Heterophoria Symptom Questionnaire (VHSQ) as well as Headache Disability Index (HDI) survey is used on all Emergency Department (ED) headache patients to assess medical history and symptom burden. Prism testing (or Prism Challenge) is performed by the study optometrist to identify those who have Vertical Heterophoria (VH). Prism Challenge is similar to prescription eyeglass testing, but with unique lenses that are meant to reduce strain on eyes that are misaligned. Follow-up questionnaires are then administered to assess any improvement in symptom burden.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632787


Locations
United States, Michigan
Vision Specialists of Michigan
Bloomfield Hills, Michigan, United States, 48302
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Sponsors and Collaborators
Vision Specialists of Birmingham
Saint Joseph Mercy Health System
Investigators
Principal Investigator: Mark S Rosner, MD St. Joseph Mercy Hospital
Study Director: Debra Feinberg, OD Vision Specialists of Michigan
  More Information

Additional Information:
Responsible Party: Vision Specialists of Birmingham
ClinicalTrials.gov Identifier: NCT01632787     History of Changes
Other Study ID Numbers: VSofM 4-2012
First Submitted: May 15, 2012
First Posted: July 3, 2012
Last Update Posted: November 1, 2017
Last Verified: October 2017

Keywords provided by Vision Specialists of Birmingham:
Anxiety
Binocular
Chronic Headache
Dizziness
Vertical Heterophoria
Vision Dysfunction

Additional relevant MeSH terms:
Strabismus
Vision Disorders
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms