Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria
VH
VH
Sponsor study identifier
observational
86
1 country
2
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 15, 2012
Actual (reported)July 3, 2012
Actual (reported)April 2016
Actual (reported)April 2016
Actual (reported)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
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.
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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.
Vision Specialists of Michigan
Bloomfield Hills, Michigan, 48302, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Mark S Rosner, MD
St. Joseph Mercy Hospital
Debra Feinberg, OD
Vision Specialists of Michigan
86 participants (actual enrollment reported by the registry).
First Submitted
May 15, 2012
First Posted
July 3, 2012
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
November 1, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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