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

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.

Condition	Intervention	Phase
Binocular Dysfunction Vertical Heterophoria Vision, Binocular Vision Disparity	Device: Lenses containing prismatic correction Device: Lenses not containing prismatic correction	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Dizziness and Vertigo Headache

Genetic and Rare Diseases Information Center resources: Ocular Motility Disorders Motor Neuro-ophthalmic Disorders

U.S. FDA Resources

Further study details as provided by Vision Specialists of Birmingham:

Primary Outcome Measures:

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 after wearing the second pair of glasses, and when treatment is completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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, 5-7 days after wearing the second pair of glasses, and when treatment is completed ] [ Designated as safety issue: No ]


Enrollment:	13
Study Start Date:	November 2008
Study Completion Date:	November 2015
Primary Completion Date:	November 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Standard (Treatment)	Device: 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.
Sham Comparator: Placebo (control)	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.

Eligibility


Ages Eligible for Study:	14 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785135

Locations


United States, Michigan
Vision Specialists of Birmingham
Birmingham, Michigan, United States, 48009

Sponsors and Collaborators

Vision Specialists of Birmingham

Essilor International

Investigators


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

More Information


Responsible Party:	Vision Specialists of Birmingham
ClinicalTrials.gov Identifier:	NCT00785135 History of Changes
Other Study ID Numbers:	VSofB 20081276
Study First Received:	November 3, 2008
Last Updated:	December 8, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by Vision Specialists of Birmingham:


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

Additional relevant MeSH terms:


Headache Dizziness Vertigo Strabismus Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms	Sensation Disorders Vestibular Diseases Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases Ocular Motility Disorders Cranial Nerve Diseases Eye Diseases

ClinicalTrials.gov processed this record on September 27, 2016