N/A
N=161
How Has Glaucoma Affected Your Quality of Life?
Glaucoma · Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT01476644 ↗Enrolled (actual)
161
Serious AEs
3.1%
Results posted
Oct 2019
Primary outcome: Primary: Quality of Life With NEI VFQ-25 — 82.9; 82.7; 82.8; 83.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clinical evaluation (Other); Performance based measures (Other); Subjective measures of vision-related quality of life (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wills Eye
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life With NEI VFQ-25 |
82.9; 82.7; 82.8; 83.0 | — |
| SECONDARY Eye Comfort With MGSS |
84.0; 84.5; 86.1; 85.0 | <0.01 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT01476644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.