How Has Glaucoma Affected Your Quality of Life?
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
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:
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:
|
Outcome Measures
Primary Outcome Measures
- Quality of Life With NEI VFQ-25 [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.
Secondary Outcome Measures
- Eye Comfort With MGSS [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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wills Eye Institute | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Wills Eye
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: George L Spaeth, MD, Glaucoma Service, Wills Eye Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- IRB#11-128
Study Results
Participant Flow
| Recruitment Details | Moderate glaucoma subjects recruited from the Glaucoma Service at Wills Eye Hospital, Philadelphia, Pennsylvania between May 2012 and May 2014 for an observational longitudinal study. One baseline and four annual visits were performed. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Participants With Moderate Glaucoma |
|---|---|
| Arm/Group Description | Participants with moderate glaucoma as defined by a disc damage likelihood scale (DDLS range 1 to 9) of the optic nerve between 5 and 8 in at least one eye. One on the DDLS corresponds to healthy optic nerve; 9 is advanced glaucoma damage. |
| Period Title: Overall Study | |
| STARTED | 161 |
| COMPLETED | 122 |
| NOT COMPLETED | 39 |
Baseline Characteristics
| Arm/Group Title | Cohort |
|---|---|
| Arm/Group Description | Moderate glaucoma with a DDLS (optic disc damage likelihood scale range 1-10 with 10 being worse ) between 5 and 8 in at least one eye. |
| Overall Participants | 161 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
85
52.8%
|
| >=65 years |
76
47.2%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
86
53.4%
|
| Male |
75
46.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
2
1.2%
|
| Not Hispanic or Latino |
159
98.8%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
13
8.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
52
32.3%
|
| White |
96
59.6%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United States |
161
100%
|
| NEI-VFQ 25 (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
83.5
(14.3)
|
| MGSS (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
83.7
(13.1)
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort |
|---|---|
| Arm/Group Description | Moderate glaucoma participants based on a DDLS (disc damage likelihood scale, a grade of the health of the optic nerve) between 5 and 8 in at least one eye. DDLS score ranges from 1 to 10 with 10 being worst optic nerve. |
| Measure Participants | 161 |
| Visit 2 |
82.9
(13.6)
|
| Visit 3 |
82.7
(14.7)
|
| Visit 4 |
82.8
(13.5)
|
| Visit 5 |
83.0
(14.8)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort |
|---|---|
| Arm/Group Description | All participants with moderate glaucoma measured by a DDLS (disc damage likelihood scale) between 5 and 8 in at least one eye agreed to the study. |
| Measure Participants | 161 |
| Visit 2 |
84.0
(12.6)
|
| Visit 3 |
84.5
(13.0)
|
| Visit 4 |
86.1
(10.9)
|
| Visit 5 |
85.0
(13.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
Adverse Events
| Time Frame | 1 visit per year over 4 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Cohort | |
| Arm/Group Description | Moderate glaucoma as confirmed by a DDLS (disc damage likelihood scale, optic nerve health) between 5 and 8 in at least one eye. DDLS range 1 to 10 with 10 being worse optic nerve damage. | |
All Cause Mortality |
||
| Cohort | ||
| Affected / at Risk (%) | # Events | |
| Total | 5/161 (3.1%) | |
Serious Adverse Events |
||
| Cohort | ||
| Affected / at Risk (%) | # Events | |
| Total | 5/161 (3.1%) | |
| Investigations | ||
| Death | 5/161 (3.1%) | 5 |
Other (Not Including Serious) Adverse Events |
||
| Cohort | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/161 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | George L. Spaeth, MD |
|---|---|
| Organization | Wills Eye Hospital, Glaucoma Research Center |
| Phone | 215-928-3123 |
| gspaeth@willseye.org |
- IRB#11-128