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

NCT ID: NCT00785135

Last Updated: 2020-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2015-11-30

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.

Conditions

Binocular Dysfunction; Vertical Heterophoria; Vision, Binocular; Vision Disparity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard (Treatment)

Group Type: ACTIVE_COMPARATOR

Lenses containing prismatic correction

Intervention Type: DEVICE

The patient will receive lenses containing prismatic correction for heterophoria, as well as correction for hyperopia, myopia and astigmatism as indicated during initial examination.

Placebo (control)

Group Type: SHAM_COMPARATOR

Lenses not containing prismatic correction

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Essilor International

INDUSTRY

Sponsor Role: collaborator

Vision Specialists of Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark S Rosner, MD

Role: PRINCIPAL_INVESTIGATOR

Vision Specialists of Birmingham

Locations

Vision Specialists of Birmingham

Birmingham, Michigan, United States

Countries

United States

Other Identifiers

VSofB 20081276

Identifier Type: -

Identifier Source: org_study_id