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

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.

Study Overview

• Status: Terminated
• Conditions: Vertical Heterophoria; Binocular Dysfunction; Vision, Binocular; Vision Disparity
• Intervention / Treatment: Device: Lenses containing prismatic correction; Device: Lenses not containing prismatic correction

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Birmingham, Michigan, United States, 48009
      • Vision Specialists of Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evidence of change / improvement of symptoms of headache, dizziness and anxiety as demonstrated by validated, self-administered survey tools for these symptoms	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

Outcome Measure	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Vision Specialists of Birmingham
• Collaborators: Essilor International
• Investigators: Principal Investigator: Mark S Rosner, MD, Vision Specialists of Birmingham

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: November 3, 2008
• First Submitted That Met QC Criteria: November 3, 2008
• First Posted (Estimate): November 5, 2008

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: neck pain; anxiety; headache; panic disorder; diplopia; vision, binocular; vision disparity; dizziness; learning disorders; asthenopia; motion sickness; depth perception; gait disorder; photophobia; agoraphobia
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Pain; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Cranial Nerve Diseases; Vestibular Diseases; Sensation Disorders; Ocular Motility Disorders; Vertigo; Dizziness; Strabismus; Headache
• Other Study ID Numbers: VSofB 20081276

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No