- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01667861
Risk Factors for Glaucoma in Musicians
May 22, 2015 updated by: Henny Beckers
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maastricht, Netherlands, 6202 AZ
- University Eye Clinic, Maastricht University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
(Professional) musicians, who play in symphony or wind orchestras.
Description
Inclusion Criteria:
- All full time or part time professional players of participating symphony or wind orchestras, including guest players.
- Retired players, if possible.
Exclusion Criteria:
- Difficulty in reading or speaking Dutch.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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(Wind) musicians
Members of (professional) orchestras, especially wind instrument players.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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One hour.
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IOP peaks and variations during continuous IOP monitoring
Time Frame: 24 hours
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Several high-risk participants will be asked their permission to perform continuous IOP monitoring during 24 hours with a sensing contact lens.
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk factors for glaucoma and the prevalence of visual problems and eye disease among (professional) musicians
Time Frame: 2 years
|
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.
|
2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Henny JM Beckers, MD, PhD, Maastricht University Medical Center, NL
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
August 10, 2012
First Submitted That Met QC Criteria
August 16, 2012
First Posted (Estimate)
August 17, 2012
Study Record Updates
Last Update Posted (Estimate)
May 25, 2015
Last Update Submitted That Met QC Criteria
May 22, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL25853.068.09/MEC09-2-112
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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