Effects of Prismatic Spectacle Lenses on Symptoms of Dizz... | NCT00785135

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

NCT00785135

Sponsor

Vision Specialists of Birmingham

Status

Terminated

Last Update Posted

Oct 12, 2020Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Binocular Dysfunction
Vertical Heterophoria
Vision, Binocular
Vision Disparity

Interventions

Lenses containing prismatic correction
Lenses not containing prismatic correction

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to recruit - multiple reasons.- inclusion/exclusion criteria too strict was th emain reason.

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Nov 3, 2008

First Submission Date that Met QC Criteria

Nov 3, 2008

First Posted Date

Nov 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2020

Last Update Posted Date

Oct 12, 2020Actual

Name	Class
Essilor International	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Label	Type	Description	Intervention Names
Standard (Treatment)	Active Comparator		Device: Lenses containing prismatic correction
Placebo (control)	Sham Comparator		Device: Lenses not containing prismatic correction

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006261	Headache
D004244	Dizziness
D001008	Anxiety Disorders
D019547	Neck Pain
D007859	Learning Disabilities
D001248	Asthenopia
D009041	Motion Sickness
D051346	Mobility Limitation
D004172	Diplopia
D020795	Photophobia
D000379	Agoraphobia
D016584	Panic Disorder

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012678	Sensation Disorders
D001523	Mental Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations
D009422	Nervous System Diseases
D065886	Neurodevelopmental Disorders
D005128	Eye Diseases
D014786	Vision Disorders
D010698	Phobic Disorders