NCT01027039

Brief Summary

The purpose of this study is to examine if there is a difference between glaucoma patients having background music and not having background music before visual field testing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2009

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

December 4, 2009

Last Update Submit

November 8, 2016

Conditions

Keywords

primary open angle glaucomapigmentary glaucomaexfoliative glaucomaangle closure glaucomalow tension glaucoma

Study Arms (3)

Patients using noise-reducing headphones

Patients using noise-reducing headphones

Patients using no headphones

Patients using no headphones

Patients using headphones with music

Patients using headphones with music

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

glaucoma service

You may qualify if:

  • Age range: 40-80 years
  • Best corrected visual acuity: 20/50 or better in both eyes
  • Experienced visual field test takers only: Patient has taken at least 2 prior visual field tests
  • Mean defect values: MD no greater than 15
  • Reliability on prior visual field indices must each be less than or equal to 40%
  • Glaucoma type: Open angle glaucoma (including primary open angle glaucoma, pigmentary glaucoma and exfoliative glaucoma) angle closure glaucoma and low tension glaucoma
  • Visual field testing program: Humphrey 24-2 Sita Standard
  • Number of eyes per patient: Both (2) eyes will be tested for each subject

You may not qualify if:

  • Patients with other ocular disease affecting central vision other than mild- moderate nuclear sclerosis (i.e. patients with macular scar, age-related macular degeneration, diabetic retinopathy, etc.)
  • Systemic conditions affecting ability to take HVF (i.e. dementia, CVA, severe arthritis, etc.)
  • Any visual field taken that is not the Humphrey 24-2 SITA Standard field will not be acceptable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Shue B, Chatterjee A, Fudemberg S, Katz LJ, Moster MR, Navarro MJ, Pro M, Schmidt C, Spaeth GL, Stirbu O, Yalcin A, Myers JS. The effects of Mozart's music on the performance of glaucoma patients on automated perimetry. Invest Ophthalmol Vis Sci. 2011 Sep 21;52(10):7347-9. doi: 10.1167/iovs.11-7430.

    PMID: 21828156BACKGROUND

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-AngleGlaucoma, Angle-ClosureLow Tension Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesOptic Nerve Diseases

Study Officials

  • Jonathan Myers

    Wills Eye

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 4, 2009

First Posted

December 7, 2009

Study Start

June 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 10, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

A manuscript has been published.

Locations