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

Vision Specialists of Birmingham

Status: Terminated

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

Treatments: Device: Lenses containing prismatic correction; Device: Lenses not containing prismatic correction

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00785135

VSofB 20081276

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 14+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 2 patient groups

Standard (Treatment)

Active Comparator group

Treatment:

Device: Lenses containing prismatic correction

Placebo (control)

Sham Comparator group

Treatment:

Device: Lenses not containing prismatic correction