Birmingham, Michigan 48009

  • Vision Disparity

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.


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


Study is Available At:


Original ID:

VSofB 20081276


NCT ID:

NCT00785135


Secondary ID:


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

14 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vision Specialists of Birmingham


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Unable to recruit - multiple reasons.- inclu


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

13


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mark S Rosner, MD
Principal Investigator
Vision Specialists of Birmingham

Study Dates

Start Date:November 2008
Completion Date:November 2015
Completion Type:Actual
Primary Completion Date:November 2015
Primary Completion Type:Actual
Verification Date:December 2015
Last Changed Date:October 7, 2020
First Received Date:November 3, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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 af
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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-
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Lenses containing prismatic correction
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.
Arm Name:Standard (Treatment)
Intervention Type:Device
Name:Lenses not containing prismatic correction
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.
Arm Name:Placebo (control)

Study Arms

Study Arm Type:Active Comparator
Arm Name:Standard (Treatment)
Study Arm Type:Sham Comparator
Arm Name:Placebo (control)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vision Specialists of Birmingham
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Essilor International

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 07, 2022

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