How Has Glaucoma Affected Your Quality of Life?

November 1, 2019 updated by: George L. Spaeth MD, Wills Eye

A Prospective, Longitudinal, Observational Cohort Study Examining How Glaucoma Affects Quality of Life and Visual Function Over a 4-Year Period

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Glaucoma Patients
Moderate glaucoma patients with a minimum 2-year diagnosis of primary open-angle glaucoma, chronic primary angle-closure glaucoma or pseudoexfoliation glaucoma were included to complete annual visits over a 4 year period. Each visit included (1) Clinical evaluation: a slit lamp examination, fundoscopy, intraocular pressure measurement, visual field examination, spectral domain optical coherence tomography, Pelli-Robson Contrast Sensitivity test and the Spaeth-Richman Contrast Sensitivity test; (2) a performance based measures: the Compressed Assessment of Ability Related to Vision; and (3) Subjective measures of vision-related quality of life (VRQoL) (the National Eye Institute Visual Functioning Questionnaire 25 and the Modified Glaucoma Symptom Scale).
Other: Clinical evaluation
Biomicroscopy (look at front of eye), ophthalmoscopy (look at back of eye), visual acuity, visual fields, intraocular pressure, spectral domain optical coherence tomography, Pelli-Robson and the Spaeth-Richman Contrast Sensitivity tests
Other Names:
  • Ophthalmic examination
Other: Performance based measures
Compressed Assessment of Ability Related to Vision (CAARV) items include: 1) computerized motion detection; 2) recognizing facial expressions; 3) reading street signs; and 4) finding objects in a room
Other Names:
  • Compressed Assessment of Ability Related to Vision
Other: Subjective measures of vision-related quality of life
National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) includes a series of questions pertaining to vision or feelings about a vision condition and the Modified Glaucoma Symptom Scale (MGSS) includes a series of questions pertaining to eye comfort.
Other Names:
  • Visual Functioning Questionnaire; Modified Glaucoma Symptom Scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life With NEI VFQ-25
Time Frame: 2 hours at each annual visit, visits 2 through 5
National Eye Institute Visual Function-25 questionnaire (NEI VFQ-25) is a measurement of patients perception of their visually related quality of life. Patients select answers from multiple choice lists of responses. Values are re-coded and converted to a scale of 0 to 100 where 0 is extreme difficulty and 100 is no difficulty at all (or best quality of life). Data from visits 2 through 5.
2 hours at each annual visit, visits 2 through 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eye Comfort With MGSS
Time Frame: 2 hours at each annual visit, visits 2 through 5
Modified Glaucoma Symptom Scale (MGSS), is patient perception of their eyes comfort. Ten ocular complaints often associated with glaucoma each have a four level score (1 signifying very bothersome; 4 represents absence of problems). Scores from 10 questions are added and range from 0 to 100 where 0 represents significant discomfort and 100 represents no problems at all. The final MGSS score is an unweighted average of responses to 10 items, averaged between the 2 eyes. Data from visits 2 through 5.
2 hours at each annual visit, visits 2 through 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wills Eye

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: George L Spaeth, MD, Glaucoma Service, Wills Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

October 31, 2011

First Submitted That Met QC Criteria

November 21, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#11-128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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