GlaucomaNCT02612571
Comparing Rates of Glaucoma in Professional Wind Versus Non-Wind Instrument Players
An observational study of Glaucoma and Intraocular Pressure, run by Wills Eye at 1 site in United States.
Trial summary
The purpose of the present study is to compare rates of glaucomatous optic neuropathy in professional wind versus non-wind instrument players in the Philadelphia Orchestra. A secondary objective is to evaluate intra-ocular pressure and choroidal thickness of wind instrument players under variable playing conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Intraocular Pressure, Optic Neuropathy
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Current and retired members of the Philadelphia Orchestra who play or played wind and non-wind instruments for an average of 1 hour per day for a minimum of 5 years.
Who may be able to join
- Play wind or non-wind instrument for average of 1 hour per day for minimum of 5 years.
- Normal general health.
Who cannot join
- Incisional eye surgery <1 month prior to visit 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Comparing Rates of Glaucomatous Optic Neuropathy in Professional Wind Versus Non-wind Instrument Players in the Philadelphia Orchestra
The purpose of the present study is to compare rates of glaucomatous optic neuropathy in professional wind versus non-wind instrument players in the Philadelphia Orchestra. A secondary objective is to evaluate intra-ocular pressure and choroidal thickness of wind instrument players under variable playing conditions.
Read the detailed description
Participants of this study will be any current or retired member of the Philadelphia Orchestra. Approximately 100 participants will be divided into 2 groups: 1) wind instrument players and 2) non-wind instrument players.
A wind instrument is defined as any instrument that contains a resonator, in which a column of air is set into resonation by the player blowing into a mouthpiece at one end of the resonator. A non-wind instrument is defined as any instrument that does not meet the wind instrument criteria.
On the day of the eye examinations, the investigator will provide a brief overview to explain the purpose and goals of the study to all potential participants. The examination team will be set up in an adjoining room. Members of the orchestra will be able to visit the examination team at any time during their practice session. A trained technician will perform the following for both eyes for all participants:visual acuity,undilated fundus color photography and intra-ocular pressure measurement. The investigators will record the examination findings using a standard form. Demographic information, including ocular, medical, social, and family history, will be documented for all participants.
- Conditions
- Glaucoma, Intraocular Pressure, Optic Neuropathy
- Medical subject headings
- Glaucoma, Optic Nerve Diseases
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 |
|---|---|---|
| Wind instrument players | A wind instrument is defined as any instrument that contains a resonator, in which a column of air is set into resonation by the player blowing into a mouthpiece at one end of the resonator. | |
| Non-wind instrument players | A non-wind instrument is defined as any instrument that does not contain a resonator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP) in wind and non-wind instrument players
Compare IOP in wind and non-wind instrument players
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L. Jay Katz MD, Wills Eye
- Investigators
- L J Katz, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612571
- Sponsor's protocol ID
- 15-495
- Status last verified
- Nov 2016
- First submitted
- 6 Aug 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Manuscript has been written and submitted to American Journal of Ophthalmology.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Rates of Glaucomatous Optic Neuropathy in Professional Wind Versus Non-wind Instrument Players in the Philadelphia Orchestra
- ClinicalTrials.gov ID
- NCT02612571
- Acronym / sponsor ID
- 15-495
- Conditions
- Glaucoma, Intraocular Pressure, Optic Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Nov 2015 (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 the present study is to compare rates of glaucomatous optic neuropathy in professional wind versus non-wind instrument players in the Philadelphia Orchestra. A secondary objective is to evaluate intra-ocular pressure and choroidal thickness of wind instrument players under variable playing conditions.
Detailed description
Participants of this study will be any current or retired member of the Philadelphia Orchestra. Approximately 100 participants will be divided into 2 groups: 1) wind instrument players and 2) non-wind instrument players.
A wind instrument is defined as any instrument that contains a resonator, in which a column of air is set into resonation by the player blowing into a mouthpiece at one end of the resonator. A non-wind instrument is defined as any instrument that does not meet the wind instrument criteria.
On the day of the eye examinations, the investigator will provide a brief overview to explain the purpose and goals of the study to all potential participants. The examination team will be set up in an adjoining room. Members of the orchestra will be able to visit the examination team at any time during their practice session. A trained technician will perform the following for both eyes for all participants:visual acuity,undilated fundus color photography and intra-ocular pressure measurement. The investigators will record the examination findings using a standard form. Demographic information, including ocular, medical, social, and family history, will be documented for all participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wind instrument players | – | –A wind instrument is defined as any instrument that contains a resonator, in which a column of air is set into resonation by the player blowing into a mouthpiece at one end of the resonator. |
| Non-wind instrument players | – | –A non-wind instrument is defined as any instrument that does not contain a resonator. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Current and retired members of the Philadelphia Orchestra who play or played wind and non-wind instruments for an average of 1 hour per day for a minimum of 5 years.
Key inclusion criteria (2 listed)
- Play wind or non-wind instrument for average of 1 hour per day for minimum of 5 years.
- Normal general health.
Key exclusion criteria (1 listed)
- Incisional eye surgery <1 month prior to visit 1.
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
Intraocular pressure (IOP) in wind and non-wind instrument players
Time frame: 1 year
Compare IOP in wind and non-wind instrument players
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 22 Nov 2016.
- Individual participant dataSharing planned: Yes. Manuscript has been written and submitted to American Journal of Ophthalmology.
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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.
L J Katz, MD principal investigator
Wills Eye Hospital
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 and Intraocular Pressure, 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 2 inclusion and 1 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 22 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.
What does the primary outcome measure?
Intraocular pressure (IOP) in wind and non-wind instrument players (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2016.