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

Binocular Dysfunction research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Binocular Dysfunction

Vertical Heterophoria

Vision, Binocular

Vision Disparity

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Device:Lenses not containing prismatic correctionThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Standard (Treatment)

Placebo (control)

Study Status

Completed

Start Date: November 2008

Completed Date: November 2015

Phase: Phase 3

Type: Interventional

Design:

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

Secondary Outcome: 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

Study sponsors, principal investigator, and references

Principal Investigator: Mark S Rosner, MD

Lead Sponsor: Vision Specialists of Birmingham

Collaborator: Essilor International

More information:https://clinicaltrials.gov/show/NCT00785135

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