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

Primary Purpose

Binocular Dysfunction, Vertical Heterophoria, Vision, Binocular

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lenses containing prismatic correction
Lenses not containing prismatic correction
Sponsored by
Vision Specialists of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binocular Dysfunction focused on measuring vision, binocular, vision disparity, headache, dizziness, anxiety, neck pain, learning disorders, asthenopia, motion sickness, depth perception, gait disorder, diplopia, photophobia, agoraphobia, panic disorder

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vision Specialists of Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Standard (Treatment)

Placebo (control)

Arm Description

Outcomes

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

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

Full Information

First Posted
November 3, 2008
Last Updated
October 7, 2020
Sponsor
Vision Specialists of Birmingham
Collaborators
Essilor International
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1. Study Identification

Unique Protocol Identification Number
NCT00785135
Brief Title
Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit - multiple reasons.- inclusion/exclusion criteria too strict was th emain reason.
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vision Specialists of Birmingham
Collaborators
Essilor International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binocular Dysfunction, Vertical Heterophoria, Vision, Binocular, Vision Disparity
Keywords
vision, binocular, vision disparity, headache, dizziness, anxiety, neck pain, learning disorders, asthenopia, motion sickness, depth perception, gait disorder, diplopia, photophobia, agoraphobia, panic disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard (Treatment)
Arm Type
Active Comparator
Arm Title
Placebo (control)
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Lenses containing prismatic correction
Intervention Description
The patient will receive lenses containing prismatic correction for heterophoria, as well as correction for hyperopia, myopia and astigmatism as indicated during initial examination.
Intervention Type
Device
Intervention Name(s)
Lenses not containing prismatic correction
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Rosner, MD
Organizational Affiliation
Vision Specialists of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vision Specialists of Birmingham
City
Birmingham
State/Province
Michigan
ZIP/Postal Code
48009
Country
United States

12. IPD Sharing Statement

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

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