GlaucomaNCT01027039
Will Listening to Music Make it Easier to Take a Visual Field Test?
An observational study of Glaucoma, run by Wills Eye at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: glaucoma service
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Effect of Mozart Music on Visual Field Testing in Glaucoma Patients: Will Music Tame the Savage Perimeter?
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.
Read the 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.
- Conditions
- Glaucoma
- Keywords
- primary open angle glaucoma, pigmentary glaucoma, exfoliative glaucoma, angle closure glaucoma, low tension glaucoma
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients using noise-reducing headphones | Patients using noise-reducing headphones | |
| Patients using no headphones | Patients using no headphones | |
| Patients using headphones with music | Patients using headphones with music |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathon Myers, Wills Eye
- Investigators
- Jonathan Myers, Principal investigator, Wills Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027039
- Sponsor's protocol ID
- 07-829E
- Status last verified
- Nov 2016
- First submitted
- 4 Dec 2009
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A manuscript has been published.
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. doi: 10.1167/iovs.11-7430.
PubMed 21828156
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mozart Music on Visual Field Testing in Glaucoma Patients: Will Music Tame the Savage Perimeter?
- ClinicalTrials.gov ID
- NCT01027039
- Acronym / sponsor ID
- 07-829E
- Conditions
- Glaucoma
- Keywords
- primary open angle glaucoma, pigmentary glaucoma, exfoliative glaucoma, angle closure glaucoma, low tension glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 7 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients using noise-reducing headphones | – | –Patients using noise-reducing headphones |
| Patients using no headphones | – | –Patients using no headphones |
| Patients using headphones with music | – | –Patients using headphones with music |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- glaucoma service
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- Background: PubMed 21828156Shue 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. doi: 10.1167/iovs.11-7430.
- Individual participant dataSharing planned: Yes. A manuscript has been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Myers principal investigator
Wills Eye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01027039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2016.