Expired Study
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Philadelphia, Pennsylvania 19107


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Play wind or non-wind instrument for average of 1 hour per day for minimum of 5 years. - Normal general health. Exclusion Criteria: - Incisional eye surgery <1 month prior to visit 1.


Study is Available At:


Original ID:

15-495


NCT ID:

NCT02612571


Secondary ID:


Study Acronym:


Brief Title:

Comparing Rates of Glaucoma in Professional Wind Versus Non-Wind Instrument Players


Official Title:

Comparing Rates of Glaucomatous Optic Neuropathy in Professional Wind Versus Non-wind Instrument Players in the Philadelphia Orchestra


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wills Eye


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

51


Enrollment Type:

Actual


Overall Contact Information

Official Name:L J Katz, MD
Principal Investigator
Wills Eye Hospital

Study Dates

Start Date:July 2015
Completion Date:July 2016
Completion Type:Actual
Primary Completion Date:July 2016
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 20, 2016
First Received Date:August 6, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Intraocular pressure (IOP) in wind and non-wind instrument players
Time Frame:1 year
Safety Issues:False
Description:Compare IOP in wind and non-wind instrument players

Study Interventions

Intervention Type:Device
Name:Intra-ocular Pressure meas
Description:Coompare rates of glaucomatous optic neuropathy in professional wind-instrument players versus non-wind instrument players
Arm Name:Wind instrument players

Study Arms

Study Arm Type:Other
Arm Name:Non-wind instrument players
Description:A non-wind instrument is defined as any instrument that does not contain a resonator.
Study Arm Type:Other
Arm Name:Wind instrument players
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Wills Eye

Samples and Retentions

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.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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