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临床试验/NCT01632787
NCT01632787已完成不适用

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

Vision Specialists of Birmingham2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
2
主要终点
VH Diagnosis

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

VH Diagnosis

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Vision Specialists of Birmingham
申办方类型
Other
责任方
Sponsor

研究点 (2)

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