Binocular Vision DysfunctionVHNCT01632787
Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria
An observational study of Binocular Vision Dysfunction and Vertical Heterophoria, run by Vision Specialists of Birmingham at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binocular Vision Dysfunction, Vertical Heterophoria
- What is being tested?
- Questionnaires and Optometrist Prism Challenge/Treatment
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vision Specialists of Michigan
Bloomfield Hills, Michigan, 48302
St. Mary Mercy Hospital
Livonia, Michigan, 48154
About this study
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.
- Being tested
- Questionnaires and Optometrist Prism Challenge/Treatment
- Keywords
- Anxiety, Binocular, Chronic Headache, Dizziness, Vertical Heterophoria, Vision Dysfunction
- Medical subject headings
- Anxiety Disorders, Headache Disorders, Dizziness, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and Optometrist Prism Challenge/TreatmentOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
VH Diagnosis
Significant reduction of symptom burden as reflected on follow-up Severity Index (SI) score with prismatic spectacle challenge and treatment.
Measured: 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.
Measured: 2-4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binocular Vision DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vision Specialists of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Trinity Health Michigan
- Responsible party
- Sponsor
- Investigators
- Mark S Rosner, MD, Principal investigator, St. Joseph Mercy HospitalDebra Feinberg, OD, Study director, Vision Specialists of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632787
- Sponsor's protocol ID
- VSofM 4-2012
- Acronym
- VH
- Status last verified
- Oct 2017
- First submitted
- 15 May 2012
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria
- ClinicalTrials.gov ID
- NCT01632787
- Acronym / sponsor ID
- VH / VSofM 4-2012
- Keywords
- Anxiety, Binocular, Chronic Headache, Dizziness, Vertical Heterophoria, Vision Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Vision Specialists of BirminghamUniversity, hospital or other
- Collaborators
- Trinity Health Michigan
- Study start
- Apr 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires and Optometrist Prism Challenge/TreatmentA 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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Rosner, MD principal investigator
St. Joseph Mercy Hospital
Debra Feinberg, OD study director
Vision Specialists of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Binocular Vision Dysfunction and Vertical Heterophoria, run by Vision Specialists of Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VH Diagnosis (time frame: 2-4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.