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

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ClinicalTrials.gov Identifier: NCT01632787
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
Saint Joseph Mercy Health System
Information provided by (Responsible Party):
Vision Specialists of Birmingham

May 15, 2012
July 3, 2012
November 1, 2017
April 2012
April 2016   (Final data collection date for primary outcome measure)
  • 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.
VH Diagnosis [ Time Frame: 2-4 Weeks ]
Significant reduction of symptom burden as reflected on follow-up SI Score and VHSQ with prismatic spectacle challenge and treatment.
Complete list of historical versions of study NCT01632787 on ClinicalTrials.gov Archive Site
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Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria
Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
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.
  • Binocular Vision Dysfunction
  • Vertical Heterophoria
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
100
April 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01632787
VSofM 4-2012
No
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Vision Specialists of Birmingham
Vision Specialists of Birmingham
Saint Joseph Mercy Health System
Principal Investigator: Mark S Rosner, MD St. Joseph Mercy Hospital
Study Director: Debra Feinberg, OD Vision Specialists of Michigan
Vision Specialists of Birmingham
October 2017