Unable to recruit - multiple reasons.- inclusion/exclusion criteria too strict was th emain reason.
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
Sponsor study identifier
interventional
13
1 country
1
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
November 3, 2008
Actual (reported)November 5, 2008
Actual (reported)November 2015
Actual (reported)November 2015
Actual (reported)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
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
The patient will receive lenses containing prismatic correction for heterophoria, as well as correction for hyperopia, myopia and astigmatism as indicated during initial examination.
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.
Vision Specialists of Birmingham
Birmingham, Michigan, 48009, United States
Mark S Rosner, MD
Vision Specialists of Birmingham
13 participants (actual enrollment reported by the registry).
First Submitted
November 3, 2008
First Posted
November 5, 2008
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
October 12, 2020
Record last verified: 2015-12
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Source: ClinicalTrials.gov.
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