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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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ClinicalTrials.gov Identifier: NCT00785135
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : December 9, 2015
Sponsor:
Collaborator:
Essilor International
Information provided by (Responsible Party):
Vision Specialists of Birmingham

Tracking Information
First Submitted Date  ICMJE November 3, 2008
First Posted Date  ICMJE November 5, 2008
Last Update Posted Date December 9, 2015
Study Start Date  ICMJE November 2008
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00785135 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Binocular Dysfunction
  • Vertical Heterophoria
  • Vision, Binocular
  • Vision Disparity
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Standard (Treatment)
    Intervention: Device: Lenses containing prismatic correction
  • Sham Comparator: Placebo (control)
    Intervention: Device: Lenses not containing prismatic correction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2015)
13
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2008)
50
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00785135
Other Study ID Numbers  ICMJE VSofB 20081276
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vision Specialists of Birmingham
Study Sponsor  ICMJE Vision Specialists of Birmingham
Collaborators  ICMJE Essilor International
Investigators  ICMJE
Principal Investigator: Mark S Rosner, MD Vision Specialists of Birmingham
PRS Account Vision Specialists of Birmingham
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP