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

NCT01632787 | Completed

• 1 other identifier: VSofM 4-2012
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 2

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.

Conditions

Binocular Vision Dysfunction; Vertical Heterophoria

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vision Specialists of Birmingham: lead
• Trinity Health Michigan: collaborator

Study Sites (2)

Vision Specialists of Michigan

Bloomfield Hills, Michigan, 48302, United States

Location

St. Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Anxiety Disorders; Headache Disorders; Dizziness; Vision Disorders

Interventions

Surveys and Questionnaires; Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mark S Rosner, MD

  St. Joseph Mercy Hospital

  PRINCIPAL INVESTIGATOR

• Debra Feinberg, OD

  Vision Specialists of Michigan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: July 3, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 1, 2017

Record last verified: 2017-10

Locations

US (2)