Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Vision Specialists of Birmingham.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Vision Specialists of Birmingham
Collaborator:
Essilor International
Information provided by (Responsible Party):
Vision Specialists of Birmingham
ClinicalTrials.gov Identifier:
NCT00785135
First received: November 3, 2008
Last updated: April 11, 2012
Last verified: April 2012
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Purpose
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 | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver) 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 |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Motor Neuro-ophthalmic Disorders
Ocular Motility Disorders
U.S. FDA Resources
Further study details as provided by Vision Specialists of Birmingham:
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| 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
-
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785135
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785135
Locations
| United States, Michigan | |
| Vision Specialists of Birmingham | Recruiting |
| Birmingham, Michigan, United States, 48009 | |
| Contact: Mark S Rosner, MD 248-258-9000 msr50@comcast.net | |
| Principal Investigator: Mark S Rosner, MD | |
Sponsors and Collaborators
Vision Specialists of Birmingham
Essilor International
Investigators
| Principal Investigator: | Mark S Rosner, MD | Vision Specialists of Birmingham |
More Information
No publications provided
| Responsible Party: | Vision Specialists of Birmingham |
| ClinicalTrials.gov Identifier: | NCT00785135 History of Changes |
| Other Study ID Numbers: | VSofB 20081276 |
| Study First Received: | November 3, 2008 |
| Last Updated: | April 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vision Specialists of Birmingham:
|
dizziness vision, binocular vision disparity headache anxiety neck pain learning disorders asthenopia |
motion sickness depth perception gait disorder diplopia photophobia agoraphobia panic disorder |
Additional relevant MeSH terms:
|
Strabismus Cranial Nerve Diseases Eye Diseases Nervous System Diseases Ocular Motility Disorders |
ClinicalTrials.gov processed this record on February 27, 2015