Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria (VH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Primary Completion Date :||April 2016|
|Study Completion Date :||April 2016|
Other: Questionnaires and Optometrist Prism Challenge/Treatment
- 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|