Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria
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| ClinicalTrials.gov Identifier: NCT00785135 |
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Recruitment Status :
Completed
First Posted : November 5, 2008
Last Update Posted : December 9, 2015
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Sponsor:
Vision Specialists of Birmingham
Collaborator:
Essilor International
Information provided by (Responsible Party):
Vision Specialists of Birmingham
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Brief 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.
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Binocular Dysfunction Vertical Heterophoria Vision, Binocular Vision Disparity | Device: Lenses containing prismatic correction Device: Lenses not containing prismatic correction | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 13 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, Care Provider) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | November 2008 |
| Actual Primary Completion Date : | November 2015 |
| Actual Study Completion Date : | November 2015 |
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| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Standard (Treatment) |
Device: Lenses containing prismatic correction
The patient will receive lenses containing prismatic correction for heterophoria, as well as correction for hyperopia, myopia and astigmatism as indicated during initial examination. |
| Sham Comparator: Placebo (control) |
Device: Lenses not containing prismatic correction
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. |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 14 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- First time appointment for a patient at designated optometry office for treatment of symptoms associated with Vertical Heterophoria
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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).
- 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
Exclusion Criteria:
- 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
- Previous Rx contains prismatic correction
- >18 PD of exophoria
- > 4 PD of vertical heterophoria on Initial Exam
Information from the National Library of Medicine
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): NCT00785135
Locations
| United States, Michigan | |
| Vision Specialists of Birmingham | |
| Birmingham, Michigan, United States, 48009 | |
Sponsors and Collaborators
Vision Specialists of Birmingham
Essilor International
Investigators
| Principal Investigator: | Mark S Rosner, MD | Vision Specialists of Birmingham |
| Responsible Party: | Vision Specialists of Birmingham |
| ClinicalTrials.gov Identifier: | NCT00785135 History of Changes |
| Other Study ID Numbers: |
VSofB 20081276 |
| First Posted: | November 5, 2008 Key Record Dates |
| Last Update Posted: | December 9, 2015 |
| Last Verified: | December 2015 |
Keywords provided by Vision Specialists of Birmingham:
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vision, binocular vision disparity headache dizziness anxiety neck pain learning disorders asthenopia |
motion sickness depth perception gait disorder diplopia photophobia agoraphobia panic disorder |
Additional relevant MeSH terms:
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Headache Dizziness Vertigo Strabismus Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Sensation Disorders Vestibular Diseases Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases Ocular Motility Disorders Cranial Nerve Diseases Eye Diseases |