A Prospective, Longitudinal, Observational Cohort Study Examining How Glaucoma Affects Quality of Life and Visual Function Over a 4-Year Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Quality of Life With NEI VFQ-25
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quality of Life With NEI VFQ-25
时间窗: 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.
次要结局
- Eye Comfort With MGSS(2 hours at each annual visit, visits 2 through 5)
研究者
George L. Spaeth MD
Principal Investigator
Wills Eye