Binocular DysfunctionNCT00785135
Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria
A study testing Lenses containing prismatic correction and Lenses not containing prismatic correction in people with Binocular Dysfunction and Vertical Heterophoria, run by Vision Specialists of Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate whether, in patients diagnosed with Vertical Heterophoria, the symptoms of dizziness, headache and / or anxiety are reduced or eliminated when a kind of correction called vertical prism is added to the patient's normal eye glass prescription. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Binocular Dysfunction, Vertical Heterophoria, Vision, Binocular
- What is being tested?
- Lenses containing prismatic correction and Lenses not containing prismatic correction
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2015
- Phase
- Interventional
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First time appointment for a patient at designated optometry office for treatment of symptoms associated with Vertical Heterophoria
- Must have symptoms of dizziness or headache or both:
- Dizziness defined as one or more of these: lightheadedness,dizziness, vertigo, feeling off-balance, lack of coordination / "clumsy", unsteadiness while walking or drifting / veering to one side while walking, motion sickness
- Headache defined as one or more of these: pain anywhere in the head,posterior neck / upper trapezius (upper back), face, and in and / or around the eyes
- Duration of symptoms greater than 4 months
- Evaluated for these symptoms previously by at least 1 other doctor (General Practice, Family Practice, Internal Medicine, Neurology, ENT, Emergency Medicine, Pediatrics, PM\&R, Ophthalmology).
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- Age >14
- The patient (or their representative) must be able and willing to fill out extra paperwork
- All Patients to be seen by same Optometrist for all visits
- Must be willing to wear glasses.
- The patient (or their representative) must be able to sign informed consent
- Must have a driver for Follow Up visits where Control and Treatment Glasses are dispensed, and when Washout period is initiated
- Must have a driver for Follow Up visits where Control and Treatment Glasses are dispensed, and when Washout period is initiated
- Must have previous negative Neuroimaging (HCT or MRI) that was ordered to assess for headache and / or dizziness
Who cannot join
- Previous diagnosis of strabismus, vertical heterotropia, CN 3, 4 or 6 palsy, "lazy eye"
- Previous eye injury or eye operation (including RK and Lasik)
- Diagnosis of glaucoma
- Diagnosis of cataracts
- Diagnosis of proptosis
- Previous C-spine surgery / fusion
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- Previous Rx contains prismatic correction
- >18 PD of exophoria
- > 4 PD of vertical heterophoria on Initial Exam
Trial locations and contacts
1 site in 1 country.
United States1 site
Vision Specialists of Birmingham
Birmingham, Michigan, 48009
About this study
Official title: Effects of Vertical Prism on the Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria: A Randomized, Double-blinded, Placebo-controlled, Cross-over Study
The purpose of this study is to demonstrate whether, in patients diagnosed with Vertical Heterophoria, the symptoms of dizziness, headache and / or anxiety are reduced or eliminated when a kind of correction called vertical prism is added to the patient's normal eye glass prescription.
The experiment will involve giving the patient two pairs of glasses (one pair containing the baseline prescription with vertical prism (Standard Treatment Glasses) and the other pair containing the baseline prescription but without vertical prism (Placebo Glasses)) to demonstrate which pair of glasses is most effective in reducing the symptoms of dizziness, headache and / or anxiety in these patients.
- Being tested
- Lenses containing prismatic correction, Lenses not containing prismatic correction
- Keywords
- vision, binocular, vision disparity, headache, dizziness, anxiety, neck pain, learning disorders, asthenopia, motion sickness, depth perception, gait disorder, diplopia, photophobia, agoraphobia, panic disorder
- Medical subject headings
- Headache, Dizziness, Anxiety Disorders, Neck Pain, Learning Disabilities, Asthenopia, Motion Sickness, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenses containing prismatic correctionDevice
The patient will receive lenses containing prismatic correction for heterophoria, as well as correction for hyperopia, myopia and astigmatism as indicated during initial examination.
Lenses not containing prismatic correctionDevice
The patient will receive lenses containing correction for hyperopia, myopia and astigmatism as indicated during initial examination. The patient will not receive prismatic correction in these lenses.
| Study group | Role | What they receive |
|---|---|---|
| Standard (Treatment) | Active comparator | Not described Receives: Device: Lenses containing prismatic correction |
| Placebo (control) | Sham comparator | Not described Receives: Device: Lenses not containing prismatic correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of change / improvement of symptoms of headache, dizziness and anxiety as demonstrated by validated, self-administered survey tools for these symptoms
Measured: Survey tools administered at baseline, 5-7 days after wearing the first pair of glasses, 5-7 days after wearing the second pair of glasses, and when treatment is completed
Secondary outcomes (1)
Evidence that a new survey tool developed by the authors to assess changes / improvement in dizziness, headache and anxiety associated with Vertical Heterophoria correlates to validated, self-administered survey tools for these same symptoms
Measured: New survey tool to be administered at baseline, 5-7 days after wearing the first pair of glasses, 5-7 days after wearing the second pair of glasses, and when treatment is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Unable to recruit - multiple reasons.- inclusion/exclusion criteria too strict was th emain reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binocular 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vision Specialists of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Essilor International
- Responsible party
- Sponsor
- Investigators
- Mark S Rosner, MD, Principal investigator, Vision Specialists of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785135
- Sponsor's protocol ID
- VSofB 20081276
- Status last verified
- Dec 2015
- First submitted
- 3 Nov 2008
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vertical Prism on the Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria: A Randomized, Double-blinded, Placebo-controlled, Cross-over Study
- ClinicalTrials.gov ID
- NCT00785135
- Acronym / sponsor ID
- VSofB 20081276
- Keywords
- vision, binocular, vision disparity, headache, dizziness, anxiety, neck pain, learning disorders, asthenopia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit - multiple reasons.- inclusion/exclusion criteria too strict was th emain reason.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Vision Specialists of BirminghamUniversity, hospital or other
- Collaborators
- Essilor International
- Study start
- Nov 2008
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Nov 2008 (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.
The purpose of this study is to demonstrate whether, in patients diagnosed with Vertical Heterophoria, the symptoms of dizziness, headache and / or anxiety are reduced or eliminated when a kind of correction called vertical prism is added to the patient's normal eye glass prescription.
The experiment will involve giving the patient two pairs of glasses (one pair containing the baseline prescription with vertical prism (Standard Treatment Glasses) and the other pair containing the baseline prescription but without vertical prism (Placebo Glasses)) to demonstrate which pair of glasses is most effective in reducing the symptoms of dizziness, headache and / or anxiety in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard (Treatment) | Active comparator | Device: Lenses containing prismatic correction |
| Placebo (control) | Sham comparator | Device: Lenses not containing prismatic correction |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- First time appointment for a patient at designated optometry office for treatment of symptoms associated with Vertical Heterophoria
- Must have symptoms of dizziness or headache or both:
- Duration of symptoms greater than 4 months
- Evaluated for these symptoms previously by at least 1 other doctor (General Practice, Family Practice, Internal Medicine, Neurology, ENT, Emergency Medicine, Pediatrics, PM\&R, Ophthalmology).
- Age >14
Key exclusion criteria (9 listed)
- Previous diagnosis of strabismus, vertical heterotropia, CN 3, 4 or 6 palsy, "lazy eye"
- Previous eye injury or eye operation (including RK and Lasik)
- Diagnosis of glaucoma
- Diagnosis of cataracts
- Diagnosis of proptosis
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 |
|---|---|---|
| Lenses containing prismatic correctionThe patient will receive lenses containing prismatic correction for heterophoria, as well as correction for hyperopia, myopia and astigmatism as indicated during initial examination. | Device | Standard (Treatment) |
| Lenses not containing prismatic correctionThe patient will receive lenses containing correction for hyperopia, myopia and astigmatism as indicated during initial examination. The patient will not receive prismatic correction in these lenses. | Device | Placebo (control) |
Primary outcome
Evidence of change / improvement of symptoms of headache, dizziness and anxiety as demonstrated by validated, self-administered survey tools for these symptoms
Time frame: Survey tools administered at baseline, 5-7 days after wearing the first pair of glasses, 5-7 days after wearing the second pair of glasses, and when treatment is completed
1 secondary outcome
Evidence that a new survey tool developed by the authors to assess changes / improvement in dizziness, headache and anxiety associated with Vertical Heterophoria correlates to validated, self-administered survey tools for these same symptoms
Time frame: New survey tool to be administered at baseline, 5-7 days after wearing the first pair of glasses, 5-7 days after wearing the second pair of glasses, and when treatment is completed
Results and safety
The study was stopped early (reason given: Unable to recruit - multiple reasons.- inclusion/exclusion criteria too strict was th emain reason.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
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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
Vision Specialists of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lenses containing prismatic correction and Lenses not containing prismatic correction in people with Binocular Dysfunction and Vertical Heterophoria, run by Vision Specialists of Birmingham at 1 site 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 14 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Unable to recruit - multiple reasons.- inclusion/exclusion criteria too strict was th emain reason.). Results are not available in the source record.
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?
Evidence of change / improvement of symptoms of headache, dizziness and anxiety as demonstrated by validated, self-administered survey tools for these symptoms (time frame: Survey tools administered at baseline, 5-7 days after wearing the first pair of glasses, 5-7 days after wearing the second pair of glasses, and when treatment is completed). 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 12 Oct 2020.