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

Completed

• Conditions: Vertical Heterophoria; Binocular Vision Dysfunction

• Registration Number: NCT01632787
• Lead Sponsor: Vision Specialists of Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-07-03
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VH Diagnosis	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.

Trial Locations

Locations (2)

Vision Specialists of Michigan; 🇺🇸 Bloomfield Hills, Michigan, United States

St. Mary Mercy Hospital; 🇺🇸 Livonia, Michigan, United States