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How Has Glaucoma Affected Your Quality of Life?

Primary Purpose

Glaucoma, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical evaluation
Performance based measures
Subjective measures of vision-related quality of life
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glaucoma focused on measuring Health related quality of life, Clinical measures of vision

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wills Eye Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Glaucoma Patients

Arm Description

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).

Outcomes

Primary Outcome Measures

Quality of Life With NEI VFQ-25
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.

Secondary Outcome Measures

Eye Comfort With MGSS
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.

Full Information

First Posted
October 31, 2011
Last Updated
November 1, 2019
Sponsor
Wills Eye
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01476644
Brief Title
How Has Glaucoma Affected Your Quality of Life?
Official Title
A Prospective, Longitudinal, Observational Cohort Study Examining How Glaucoma Affects Quality of Life and Visual Function Over a 4-Year Period
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Quality of Life
Keywords
Health related quality of life, Clinical measures of vision

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective, longitudinal,observational cohort study to investigate how glaucoma affects patients' quality of life and visually-related function. Annual visits 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 measure: the Compressed Assessment of Ability Related to Vision; and (3) Subjective measures of vision-related quality of life (the National Eye Institute Visual Functioning Questionnaire 25 and the Modified Glaucoma Symptom Scale).
Masking
None (Open Label)
Allocation
N/A
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glaucoma Patients
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Clinical evaluation
Other Intervention Name(s)
Ophthalmic examination
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Performance based measures
Other Intervention Name(s)
Compressed Assessment of Ability Related to Vision
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Subjective measures of vision-related quality of life
Other Intervention Name(s)
Visual Functioning Questionnaire; Modified Glaucoma Symptom Scale
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life With NEI VFQ-25
Description
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.
Time Frame
2 hours at each annual visit, visits 2 through 5
Secondary Outcome Measure Information:
Title
Eye Comfort With MGSS
Description
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.
Time Frame
2 hours at each annual visit, visits 2 through 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George L Spaeth, MD
Organizational Affiliation
Glaucoma Service, Wills Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Sun Y, Erdem E, Wizov S, Kayak N, Wei H, Spaeth GL. Quality of life measures in moderate glaucoma: study design and methodology. Abstract submitted, Association for Research in Vision and Ophthalmology, Dec 2012.
Results Reference
background
Citation
Ekici F, Sun Y, Taranum S, Martinez P, Erdem E, Nayak N, Wizov SS, Waisbourd M, Spaeth GL. Relationship between baseline clinical characteristics and vision-related quality of life in patients with glaucoma. ARVO Poster 176-A0363 May 2014.
Results Reference
background
Citation
Gogte P., Hark LA., Spaeth E., Richman J., Wizov SS., Waisbourd M., Spaeth GL. Contrast Sensitivity - A Meaningful Way to Assess Health Related Quality of Life and Ability to Perform Daily Activities in Glaucoma Patients. ARVO Poster 2097-A0004 May 2015.
Results Reference
background
Citation
Waisbourd M., Gogte P., Richman J., Spaeth E., Dai Y., Wizov SS., Hark LA., Spaeth GL. Comparative Results with Regards to Humphrey Visual Fields and the SPARCS Contrast Sensitivity Test in Patients with Glaucoma. AOS meeting April 2015.
Results Reference
background
PubMed Identifier
26231376
Citation
Waisbourd M, Parker S, Ekici F, Martinez P, Murphy R, Scully K, Wizov SS, Hark LA, Spaeth GL. A prospective, longitudinal, observational cohort study examining how glaucoma affects quality of life and visually-related function over 4 years: design and methodology. BMC Ophthalmol. 2015 Aug 1;15:91. doi: 10.1186/s12886-015-0088-x.
Results Reference
result
PubMed Identifier
26425961
Citation
Ekici F, Loh R, Waisbourd M, Sun Y, Martinez P, Nayak N, Wizov SS, Hegarty S, Hark LA, Spaeth GL. Relationships Between Measures of the Ability to Perform Vision-Related Activities, Vision-Related Quality of Life, and Clinical Findings in Patients With Glaucoma. JAMA Ophthalmol. 2015 Dec;133(12):1377-85. doi: 10.1001/jamaophthalmol.2015.3426.
Results Reference
result
PubMed Identifier
26701273
Citation
Sun Y, Lin C, Waisbourd M, Ekici F, Erdem E, Wizov SS, Hark LA, Spaeth GL. The Impact of Visual Field Clusters on Performance-based Measures and Vision-Related Quality of Life in Patients With Glaucoma. Am J Ophthalmol. 2016 Mar;163:45-52. doi: 10.1016/j.ajo.2015.12.006. Epub 2015 Dec 14.
Results Reference
result

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How Has Glaucoma Affected Your Quality of Life?

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