Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria (VH)
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|ClinicalTrials.gov Identifier: NCT01632787|
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : November 1, 2017
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 or disease||Intervention/treatment|
|Binocular Vision Dysfunction Vertical Heterophoria||Other: Questionnaires and Optometrist Prism Challenge/Treatment|
|Study Type :||Observational|
|Actual Enrollment :||86 participants|
|Official Title:||Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
- 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.
- VH Diagnosis [ Time Frame: 2-4 Weeks ]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 ]Significant reduction of symptom burden as reflected on follow-up Vertical Heterophoria Symptom Questionnaire (VHSQ) score with prismatic spectacle challenge and treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632787
|United States, Michigan|
|Vision Specialists of Michigan|
|Bloomfield Hills, Michigan, United States, 48302|
|St. Mary Mercy Hospital|
|Livonia, Michigan, United States, 48154|
|Principal Investigator:||Mark S Rosner, MD||St. Joseph Mercy Hospital|
|Study Director:||Debra Feinberg, OD||Vision Specialists of Michigan|