Glaucoma Related Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index (OSDI)
研究概览
简要总结
Subjects with a diagnosis of glaucoma will be handed out different quality of life related questionnaires and their score will be evaluated at baseline and 3-6 months after treatment or surgery was initiated/performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of glaucoma (open- as well as closed-angle glaucoma, primary and secondary glaucomas)
- •18 years of age or older with no upper limit
- •male and female subjects
排除标准
- •absence of a diagnosis of glaucoma
- •less than 18 years of age
研究组 & 干预措施
Study Arm (glaucoma)
subjects with a diagnosis of glaucoma
干预措施: GQL-15 (Other)
Study Arm (glaucoma)
subjects with a diagnosis of glaucoma
干预措施: Glaucoma Symptom Scale (Other)
Study Arm (glaucoma)
subjects with a diagnosis of glaucoma
干预措施: NEI Vision Function Questionnaire (Other)
Study Arm (glaucoma)
subjects with a diagnosis of glaucoma
干预措施: Ocular Surface Disease Index (Other)
结局指标
主要结局
Ocular Surface Disease Index (OSDI)
时间窗: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
The OSDI© is assessed on a scale of 0 to 4, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
Glaucoma Symptom Scale (GSS)
时间窗: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
The Glaucoma Symptom Scale (GSS; Lee et al., 1998) was developed as a brief symptom survey specific for persons with glaucoma. The GSS consists of a 10-item scale developed from a modified version of a symptom checklist that address ocular complaints, some of a nonvisual nature and some of a visual nature, common to patients with glaucoma. Items are scored from 0 to 100, where 100 represents the absence of symptoms and 0 represents severe, bothersome symptoms.
National Eye Institute Visual Function Questionaire (NEI VFQ)
时间窗: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
Vision-specific instrument designed to measure vision-related quality of life (VRQoL) in adults, incorporating body, activity, and participation content according to the WHO ICF Framework in order to measure the effects of a variety of ocular conditions on daily functioning and QOL. It was originally designed as a 51-point questionnaire and is currently available in both self-administered and interview-based formats. The raw scores are converted to a 0-100 scale; after reverse scoring, a high score (100) indicates better vision-specific quality of life, while a low score (0) indicates poor function.
Glaucoma Quality of Life-15 (GQL-15)
时间窗: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
The Glaucoma Quality of Life-15 (GQL-15) is a validated 15-item, self-report questionnaire used to measure visual disability and quality of life (QoL) in glaucoma patients. It covers four key areas-peripheral vision, central/near vision, glare/dark adaptation, and outdoor mobility-using a 5-point scale (1=no difficulty to 5=severe difficulty).
次要结局
未报告次要终点
研究者
Marc Toeteberg-Harms
Associate Professor
University of Iowa