Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

1. 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 :

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 [ 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 ]

Eligibility Criteria

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Ages Eligible for Study:	14 Years and older (Child, Adult, Senior)
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

• 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Vision Specialists of Birmingham
ClinicalTrials.gov Identifier:	NCT00785135 History of Changes
Other Study ID Numbers:	VSofB 20081276
First Posted:	November 5, 2008
Last Update Posted:	December 9, 2015
Last Verified:	December 2015

Keywords provided by Vision Specialists of Birmingham:

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:

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