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

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.

Study Overview

• Status: Completed
• Conditions: Binocular Vision Dysfunction; Vertical Heterophoria
• Intervention / Treatment: Other: Questionnaires and Optometrist Prism Challenge/Treatment

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
      • Vision Specialists of Michigan
    • Livonia, Michigan, United States, 48154
      • St. Mary Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VH Diagnosis	Significant reduction of symptom burden as reflected on follow-up Severity Index (SI) score with prismatic spectacle challenge and treatment.	2-4 Weeks
VH Diagnosis	Significant reduction of symptom burden as reflected on follow-up Vertical Heterophoria Symptom Questionnaire (VHSQ) score with prismatic spectacle challenge and treatment.	2-4 Weeks

Collaborators and Investigators

• Sponsor: Vision Specialists of Birmingham
• Collaborators: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 15, 2012
• First Submitted That Met QC Criteria: June 28, 2012
• First Posted (Estimate): July 3, 2012

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Anxiety; Dizziness; Binocular; Chronic Headache; Vertical Heterophoria; Vision Dysfunction
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Cranial Nerve Diseases; Sensation Disorders; Ocular Motility Disorders; Strabismus; Vision Disorders
• Other Study ID Numbers: VSofM 4-2012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No