Glaucoma, Quality of Life
Conditions
Keywords
Health related quality of life, Clinical measures of vision
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.
Interventions
OTHERClinical 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
OTHERPerformance 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
OTHERSubjective 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.
Sponsors
Merck Sharp & Dohme LLC
Wills Eye
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 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. | 161 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Lost to Follow-up | 19 |
| Overall Study | moved to another state | 2 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 76 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 159 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| MGSS | 83.7 units on a scale STANDARD_DEVIATION 13.1 |
| NEI-VFQ 25 | 83.5 units on a scale STANDARD_DEVIATION 14.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants |
| Race (NIH/OMB) Black or African American | 52 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 96 Participants |
| Region of Enrollment United States | 161 Participants |
| Sex: Female, Male Female | 86 Participants |
| Sex: Female, Male Male | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 161 |
| other Total, other adverse events | 0 / 161 |
| serious Total, serious adverse events | 5 / 161 |
Outcome results
Primary
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.
Time frame: 2 hours at each annual visit, visits 2 through 5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort | Quality of Life With NEI VFQ-25 | Visit 2 | 82.9 units on a scale | Standard Deviation 13.6 |
| Cohort | Quality of Life With NEI VFQ-25 | Visit 3 | 82.7 units on a scale | Standard Deviation 14.7 |
| Cohort | Quality of Life With NEI VFQ-25 | Visit 4 | 82.8 units on a scale | Standard Deviation 13.5 |
| Cohort | Quality of Life With NEI VFQ-25 | Visit 5 | 83.0 units on a scale | Standard Deviation 14.8 |
Secondary
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.
Time frame: 2 hours at each annual visit, visits 2 through 5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort | Eye Comfort With MGSS | Visit 2 | 84.0 units on a scale | Standard Deviation 12.6 |
| Cohort | Eye Comfort With MGSS | Visit 3 | 84.5 units on a scale | Standard Deviation 13 |
| Cohort | Eye Comfort With MGSS | Visit 4 | 86.1 units on a scale | Standard Deviation 10.9 |
| Cohort | Eye Comfort With MGSS | Visit 5 | 85.0 units on a scale | Standard Deviation 13.9 |
p-value: <0.01Regression, Linear