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How Has Glaucoma Affected Your Quality of Life?

This study is currently recruiting participants.
Verified April 2013 by Wills Eye
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
George L. Spaeth MD, Wills Eye
ClinicalTrials.gov Identifier:
NCT01476644
First received: October 31, 2011
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

Hypothesis 1: Self-reported health-related quality of life decreases as vision impairment worsens in subjects with glaucoma.

Hypothesis 2: Changes in health-related quality of life are associated with changes in clinical measures of vision and performance-based measures of visual function.


Condition
Glaucoma
Quality of Life

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Longitudinal, Observational Cohort Study Examining How Glaucoma Affects Quality of Life and Visual Function Over a 4-Year Period

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: No ]
    Quality of life questionnaire


Secondary Outcome Measures:
  • Clinical Findings [ Time Frame: 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: No ]
    Intraocular pressure

  • Quality of Life [ Time Frame: 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: No ]
    Treatment compliance

  • Performance [ Time Frame: 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: No ]
    Performance-based measures of visual function.

  • Progression [ Time Frame: 1, 2, 3, 4. and 5 years ] [ Designated as safety issue: No ]
    Progression of Disc Damage Likelihood Scale (DDLS)


Estimated Enrollment: 160
Study Start Date: October 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Detailed Description:

You are being asked to participate in this research study because you have glaucoma, which is the second leading cause of blindness in the world and accounts for 15% of blindness worldwide. Vision loss caused by glaucoma can significantly worsen your health-related quality of life. Despite the fact that glaucoma has such a big impact on a large number of people, research examining the long-term effects of glaucoma-related vision loss on one's quality of life is scarce.

The purpose of this study is to look at the long-term effect of this condition on your quality of life so that we may gain valuable information about what factors influence the quality of life of people with glaucoma. To participate in this study, you will need to allow us to perform clinical tests on your eyes, to self-report your well-being and health-related quality of life, and to let us know how well you perform your daily life activities.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects for this study will be recruited from the William A. and Anna V. Goldberg Glaucoma Service and Glaucoma Research Center at Wills Eye Institute in Philadelphia, PA.

Criteria

Inclusion Criteria:

  • Minimum 2-year diagnosis of primary open-angle glaucoma, chronic primary angle-closure glaucoma or exfoliation glaucoma
  • Disk Damage Likelihood Scale stages 5 through 8 with visual field loss
  • Age between 21 and 80 years
  • Able to understand and speak English

Exclusion Criteria:

  • Unlikely to be available for annual ocular examination and reassessment across a 4-year period
  • Neurological or musculoskeletal problems that would influence performance on activities of daily living
  • Cognitively impaired, as assessed by a face-to-face Mini-Mental State Examination
  • Incisional eye surgery within the past three months
  • Laser therapy within the previous month
  • Any cause for visual reduction other than glaucoma
  • Any medical condition which in the investigator's opinion would preclude the subject from providing reliable and valid data
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476644

Contacts
Contact: Sheryl S Wizov, COA 215-928-3221 swizov@willseye.org
Contact: Jeanne Molineaux, COA 215-825-4713 jmolineaux@willseye.org

Locations
United States, Pennsylvania
Wills Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Sheryl S Wizov, COA     215-928-3221     swizov@willseye.org    
Contact: Jeanne Molineaux, COA     215-825-4713     jmolineaux@willseye.org    
Sub-Investigator: L Jay Katz, MD            
Sub-Investigator: Jonathan S Myers, MD            
Sub-Investigator: Marlene R Moster, MD            
Sub-Investigator: Courtland M Schmidt, MD            
Sub-Investigator: Michael S Pro, MD            
Sub-Investigator: Scott J Fudemberg, MD            
Sub-Investigator: Anand Mantravadi, MD            
Sponsors and Collaborators
Wills Eye
Merck
Investigators
Principal Investigator: George L Spaeth, MD Glaucoma Service, Wills Eye Institute
  More Information

No publications provided

Responsible Party: George L. Spaeth MD, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT01476644     History of Changes
Other Study ID Numbers: IRB#11-128
Study First Received: October 31, 2011
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
Health related quality of life
Clinical measures of vision

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013