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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02612571
Other study ID # 15-495
Secondary ID
Status Completed
Phase N/A
First received August 6, 2015
Last updated November 20, 2016
Start date July 2015
Est. completion date July 2016

Study information

Verified date November 2016
Source Wills Eye
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Wills Eye Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraocular pressure (IOP) in wind and non-wind instrument players Compare IOP in wind and non-wind instrument players 1 year No
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