Will Listening to Music Make it Easier to Take a Visual Field Test?
| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 4, 2009 |
| Last Updated Date | June 24, 2010 |
| Start Date ICMJE | June 2008 |
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01027039 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Will Listening to Music Make it Easier to Take a Visual Field Test? |
| Official Title ICMJE | The Effect of Mozart Music on Visual Field Testing in Glaucoma Patients: Will Music Tame the Savage Perimeter? |
| Brief Summary | The purpose of this study is to examine if there is a difference between glaucoma patients having background music and not having background music before visual field testing. |
| 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 Ophthalmology1 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 ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Probability Sample |
| Study Population | glaucoma service |
| Condition ICMJE | Glaucoma |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) |
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| Publications * | Shue B, Chatterjee A, Fudemberg S, Katz LJ, Moster MR, Navarro MJ, Pro M, Schmidt C, Spaeth GL, Stirbu O, Yalcin A, Myers JS. The effects of Mozart's music on the performance of glaucoma patients on automated perimetry. Invest Ophthalmol Vis Sci. 2011 Sep 21;52(10):7347-9. Print 2011 Sep. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 160 |
| Completion Date | September 2009 |
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 40 Years to 80 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01027039 |
| Other Study ID Numbers ICMJE | 07-829E |
| Has Data Monitoring Committee | No |
| Responsible Party | Jonathan Myers MD, Wills Eye Glaucoma Service |
| Study Sponsor ICMJE | Wills Eye |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Wills Eye |
| Verification Date | June 2010 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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