GlaucomaNCT01667861
Risk Factors for Glaucoma in Musicians
An observational study of Glaucoma, run by Henny Beckers at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine the impact of playing wind instruments for the development of ocular hypertension and glaucoma, together with investigating the prevalence of visual problems and eye diseases in (professional) musicians. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to Jan 2015
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: (Professional) musicians, who play in symphony or wind orchestras.
Who may be able to join
- All full time or part time professional players of participating symphony or wind orchestras, including guest players.
- Retired players, if possible.
Who cannot join
- Difficulty in reading or speaking Dutch.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Eye Clinic, Maastricht University Medical Center
Maastricht, 6202 AZ
About this study
The purpose of this study is to determine the impact of playing wind instruments for the development of ocular hypertension and glaucoma, together with investigating the prevalence of visual problems and eye diseases in (professional) musicians.
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Wind instruments
- Medical subject headings
- 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 |
|---|---|---|
| (Wind) musicians | Members of (professional) orchestras, especially wind instrument players. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP levels, including IOP peaks occurring during or directly after playing, and prevalence of glaucomatous field loss in players of wind instruments.
Measured: One hour.
IOP peaks and variations during continuous IOP monitoring
Several high-risk participants will be asked their permission to perform continuous IOP monitoring during 24 hours with a sensing contact lens.
Measured: 24 hours
Secondary outcomes (1)
Risk factors for glaucoma and the prevalence of visual problems and eye disease among (professional) musicians
Participants of orchestras will be asked to fill in a questionnaire to collect demographic data together with data on musical history,ophthalmologic history and family history on glaucoma and ocular hypertension. From these participants, a selection will be invited for further screening.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startOct 2011
- Primary completionFeb 2014
- Study completionJan 2015
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
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henny Beckers
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Glaucoomfonds
- Responsible party
- Sponsor-investigator, Henny Beckers, Maastricht University Medical Center
- Investigators
- Henny JM Beckers, MD, PhD, Principal investigator, Maastricht University Medical Center, NL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667861
- Sponsor's protocol ID
- NL25853.068.09/MEC09-2-112
- Status last verified
- May 2015
- First submitted
- 10 Aug 2012
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Glaucoma in Musicians
- ClinicalTrials.gov ID
- NCT01667861
- Acronym / sponsor ID
- NL25853.068.09/MEC09-2-112
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Wind instruments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Henny BeckersUniversity, hospital or other
- Collaborators
- Stichting Glaucoomfonds
- Study start
- Oct 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Aug 2012 (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 determine the impact of playing wind instruments for the development of ocular hypertension and glaucoma, together with investigating the prevalence of visual problems and eye diseases in (professional) musicians.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (Wind) musicians | – | –Members of (professional) orchestras, especially wind instrument players. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- (Professional) musicians, who play in symphony or wind orchestras.
Key inclusion criteria (2 listed)
- All full time or part time professional players of participating symphony or wind orchestras, including guest players.
- Retired players, if possible.
Key exclusion criteria (1 listed)
- Difficulty in reading or speaking Dutch.
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
IOP levels, including IOP peaks occurring during or directly after playing, and prevalence of glaucomatous field loss in players of wind instruments.
Time frame: One hour.
IOP peaks and variations during continuous IOP monitoring
Time frame: 24 hours
Several high-risk participants will be asked their permission to perform continuous IOP monitoring during 24 hours with a sensing contact lens.
1 secondary outcome
Risk factors for glaucoma and the prevalence of visual problems and eye disease among (professional) musicians
Time frame: 2 years
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 25 May 2015.
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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.
Henny JM Beckers, MD, PhD principal investigator
Maastricht University Medical Center, NL
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 Henny Beckers at 1 site in Netherlands.
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 25 May 2015. 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 Netherlands. 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?
IOP levels, including IOP peaks occurring during or directly after playing, and prevalence of glaucomatous field loss in players of wind instruments. (time frame: One hour.). The study lists 2 primary outcomes in all. 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 25 May 2015.