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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01632787
Acronym
VH
Enrollment
86
Registered
2012-07-03
Start date
2012-04-30
Completion date
2016-04-30
Last updated
2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binocular Vision Dysfunction, Vertical Heterophoria

Keywords

Anxiety, Binocular, Chronic Headache, Dizziness, Vertical Heterophoria, Vision Dysfunction

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.

Interventions

OTHERQuestionnaires 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.

Sponsors

Trinity Health Michigan
CollaboratorOTHER
Vision Specialists of Birmingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
VH Diagnosis2-4 WeeksSignificant reduction of symptom burden as reflected on follow-up Severity Index (SI) score with prismatic spectacle challenge and treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026