- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01027039
Will Listening to Music Make it Easier to Take a Visual Field Test?
The Effect of Mozart Music on Visual Field Testing in Glaucoma Patients: Will Music Tame the Savage Perimeter?
Study Overview
Status
Conditions
Detailed Description
Glaucoma is one of the leading causes of blindness in the United States. Over 2.5 million people in the United States have glaucoma. The goal of ophthalmologists is two-fold: 1) to detect glaucoma early, and 2) to stop the progression of disease and subsequent visual loss.
Many parameters are used to detect and follow glaucoma over the patient's lifetime including optic nerve appearance, intraocular pressure by applanation and visual field perimetry testing results. Perimetry testing aims to detect visual field loss that may be associated with glaucoma and institute more aggressive treatment measures when necessary. However, it is suspected that 50% or more of the optic nerve fibers are already irreversibly damaged before a visual field defect can be identified on testing. Furthermore, the patient's ability to take a visual field test is paramount in the doctor's ability to interpret the test. That is, if a visual field test taker performs the test with low reliability (i.e. too many false positive, false negative or fixation losses), the interpretability of the test by the ophthalmologist is difficult or impossible.
Interestingly, a recent study in the British Journal of Ophthalmology suggested the positive effect Mozart music has on visual field test taking ability. This study showed better first time automated perimetry performance in normals immediately following exposure to the first 10 minutes of Mozart's Sonata for Two Pianos in D Major. The music group had 20 times fewer fixation losses, three times fewer false positive responses and 10 times fewer false negative responses.
No study has determined if Mozart music improves the reliability indices of Humphrey visual field testing for glaucoma patients or experienced test takers. In efforts to improve patient's reliability on visual field testing, we propose a randomized controlled trial to determine if listening to music before field testing improves testing reliability.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Wills Eye Glaucoma Service
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age range: 40-80 years
- Best corrected visual acuity: 20/50 or better in both eyes
- Experienced visual field test takers only: Patient has taken at least 2 prior visual field tests
- Mean defect values: MD no greater than 15
- Reliability on prior visual field indices must each be less than or equal to 40%
- Glaucoma type: Open angle glaucoma (including primary open angle glaucoma, pigmentary glaucoma and exfoliative glaucoma) angle closure glaucoma and low tension glaucoma
- Visual field testing program: Humphrey 24-2 Sita Standard
- Number of eyes per patient: Both (2) eyes will be tested for each subject
Exclusion Criteria:
- Patients with other ocular disease affecting central vision other than mild- moderate nuclear sclerosis (i.e. patients with macular scar, age-related macular degeneration, diabetic retinopathy, etc.)
- Systemic conditions affecting ability to take HVF (i.e. dementia, CVA, severe arthritis, etc.)
- Any visual field taken that is not the Humphrey 24-2 SITA Standard field will not be acceptable
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Patients using noise-reducing headphones
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Patients using no headphones
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Patients using headphones with music
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Myers, Wills Eye
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-829E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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