NCT02612571

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

August 6, 2015

Last Update Submit

November 20, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure (IOP) in wind and non-wind instrument players

    Compare IOP in wind and non-wind instrument players

    1 year

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Play wind or non-wind instrument for average of 1 hour per day for minimum of 5 years.
  • Normal general health.

You may not qualify if:

  • Incisional eye surgery \<1 month prior to visit 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

GlaucomaOptic Nerve Diseases

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesCranial Nerve DiseasesNervous System Diseases

Study Officials

  • L J Katz, MD

    Wills Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2015

First Posted

November 24, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Manuscript has been written and submitted to American Journal of Ophthalmology.

Locations