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

NCT00785135 | Terminated

• 1 other identifier: VSofB 20081276
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Keywords

vision, binocular; vision disparity; headache; dizziness; anxiety; neck pain; learning disorders; asthenopia; motion sickness; depth perception; gait disorder; diplopia; photophobia; agoraphobia; panic disorder

Outcome Measures

Primary Outcomes (1)

• Evidence of change / improvement of symptoms of headache, dizziness and anxiety as demonstrated by validated, self-administered survey tools for these symptoms

  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

Secondary Outcomes (1)

• 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

  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

Study Arms (2)

Standard (Treatment)

ACTIVE COMPARATOR

Device: Lenses containing prismatic correction

Placebo (control)

SHAM COMPARATOR

Device: Lenses not containing prismatic correction

Interventions

Lenses containing prismatic correction 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.

Standard (Treatment)

Lenses not containing prismatic correction 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.

Placebo (control)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vision Specialists of Birmingham: lead
• Essilor International: collaborator

Study Sites (1)

Vision Specialists of Birmingham

Birmingham, Michigan, 48009, United States

Location

MeSH Terms

Conditions

Headache; Dizziness; Anxiety Disorders; Neck Pain; Learning Disabilities; Asthenopia; Motion Sickness; Mobility Limitation; Diplopia; Photophobia; Agoraphobia; Panic Disorder

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Neurodevelopmental Disorders; Eye Diseases; Vision Disorders; Phobic Disorders

Study Officials

• Mark S Rosner, MD

  Vision Specialists of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 5, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 12, 2020

Record last verified: 2015-12

Locations

US (1)