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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Vision Specialists of Birmingham.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Saint Joseph Mercy Health System
Information provided by (Responsible Party):
Vision Specialists of Birmingham
ClinicalTrials.gov Identifier:
NCT01632787
First received: May 15, 2012
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Binocular Vision Dysfunction
Vertical Heterophoria
Other: Questionnaires and Optometrist Prism Challenge/Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria

Resource links provided by NLM:


Further study details as provided by Vision Specialists of Birmingham:

Primary Outcome Measures:
  • VH Diagnosis [ Time Frame: 2-4 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Significant reduction of symptom burden as reflected on follow-up Vertical Heterophoria Symptom Questionnaire (VHSQ) score with prismatic spectacle challenge and treatment.


Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Questionnaires 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632787

Contacts
Contact: Mark s Rosner, MD 734-670-7742 msr50@comcast.net

Locations
United States, Michigan
Vision Specialists of Michigan Recruiting
Bloomfield Hills, Michigan, United States, 48302
Contact: Rosner    734-670-7742      
Principal Investigator: Mark S Rosner, MD         
St. Joseph Mercy Hospital Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Rosner    734-670-7742      
Principal Investigator: Mark S Rosner, MD         
Sponsors and Collaborators
Vision Specialists of Birmingham
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
  More Information

Additional Information:
No publications provided

Responsible Party: Vision Specialists of Birmingham
ClinicalTrials.gov Identifier: NCT01632787     History of Changes
Other Study ID Numbers: VSofM 4-2012
Study First Received: May 15, 2012
Last Updated: July 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vision Specialists of Birmingham:
Anxiety
Binocular
Chronic Headache
Dizziness
Vertical Heterophoria
Vision Dysfunction

Additional relevant MeSH terms:
Strabismus
Vision Disorders
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014