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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Key information

Conditions

Binocular Vision Dysfunction Anxiety Disorders Brain Diseases Central Nervous System Diseases Dizziness Eye Diseases Headache Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vertical Heterophoria Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vision Specialists of Michigan, Bloomfield Hills, Michigan, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires and Optometrist Prism Challenge/Treatment

Other

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Vision Specialists of Birmingham

Other

Collaborators

Trinity Health Michigan

Registry information

Acronym: VH

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Jul 3, 2012
Registry last updated: Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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