Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria
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|ClinicalTrials.gov Identifier: NCT00785135|
Recruitment Status : Terminated (Unable to recruit - multiple reasons.- inclusion/exclusion criteria too strict was th emain reason.)
First Posted : November 5, 2008
Last Update Posted : October 12, 2020
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 or disease||Intervention/treatment||Phase|
|Binocular Dysfunction Vertical Heterophoria Vision, Binocular Vision Disparity||Device: Lenses containing prismatic correction Device: Lenses not containing prismatic correction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
|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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785135
|United States, Michigan|
|Vision Specialists of Birmingham|
|Birmingham, Michigan, United States, 48009|
|Principal Investigator:||Mark S Rosner, MD||Vision Specialists of Birmingham|