Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria (VH)
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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 |
- 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) |
-
Other: Questionnaires and Optometrist Prism Challenge/Treatment
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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| Contact: Mark s Rosner, MD | 734-670-7742 | msr50@comcast.net |
| 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 | |
| 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 May 19, 2013