How Has Glaucoma Affected Your Quality of Life?

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
George L. Spaeth MD, Wills Eye
ClinicalTrials.gov Identifier:
NCT01476644
First received: October 31, 2011
Last updated: September 23, 2014
Last verified: September 2014
  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:


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)


Enrollment: 163
Study Start Date: October 2011
Estimated Study Completion Date: May 2018
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476644

Locations
United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Merck Sharp & Dohme Corp.
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: September 23, 2014
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 October 19, 2014