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Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Lenses containing prismatic correction and Lenses not containing prismatic correction to evaluate Binocular Dysfunction, Vertical Heterophoria, Vision, Binocular or Vision Disparity

Research Study 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

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.

To Learn more
Phase

3

Gender

Both Male and Female

Age

14 and up

Overall Status

Recruiting

Lead Sponsor

Vision Specialists of Birmingham

Duration

49 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 14 Years and up

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

Site Locations (1)

Country State City Zip Facility and Contact
United States Michigan Birmingham 48009 Vision Specialists of Birmingham
Mark S Rosner, MD
248-258-9000
msr50@comcast.net

Mark S Rosner, MD
Principal Investigator

NCT ID: NCT00785135

Date Last Changed: April 11, 2012

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