Multicentric Observational Clinical Study on Quality of Life in Patients With Glaucoma in Italy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,226
- 试验地点
- 21
- 主要终点
- Quality of life questionnaires
研究概览
简要总结
The study aims to evaluate the quality of life (QoL) of patients affected by Primary Open-Angle Glaucoma (POAG), using 2 QoL questionnaires:
- Glaucoma Symptom Scale (GSS) and
- National Eye Institute Visual Function Questionnaire (NEI-VFQ -25). The study will be conducted on patients with well known diagnosis of POAG (transversal phase) and on patients with first diagnosis of POAG (longitudinal phase).
详细描述
The study provides two levels of investigation, the first one (transversal phase), for all patients enrolled in the participating centers and the second one (longitudinal phase) conducted in a single cohort of patients with new diagnosis of POAG at enrollment.
The study will take part in around 20 centers specialized in glaucoma treatment and care, distributed throughout the Italian country area. The study aims to recruit a total of 3000 patients, around 200 of which with early diagnosis: they will represent the longitudinal cohort.
The frequency of visits and the type of examinations will follow the normal clinical practice.
The transversal phase consists of a single visit in which all socio-demographic and clinical characteristics of patients will be collected; during this visit patients will receive the NEI-VFQ 25 and the GSS questionnaires for measuring QoL (they have be filled in by the patient himself). For newly diagnosed patients, data collected during this visit will be consider as baseline, then they will enter in the longitudinal phase and will underwent two subsequent visits, the first one after about 6 months from baseline and the second one after a further 6 months (12 months from baseline). During the two subsequent visits the same data as the baseline will be collected, excluding for the socio-demographic data.
Patients will underwent examinations and therapy suitable for their disease treatment, based on physician judgment and according to the normal clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Patients with instrumental diagnosis of POAG, already being treated at the center or at the time of diagnosis
- •Age > 18 years
- •Ability to understand and answer to the questionnaires provided by the study
- •Written consent to the processing of personal data.
- •Exclusion criteria:
- •Female patients who are pregnant, breast-feeding or plan to become pregnant, or female patients of childbearing potential not using reliable means of birth control
- •Concurrent abuse of alcohol and drugs
- •Concurrent participation in any other clinical trial that tests drugs / medical devices within the last 30 days.
排除标准
- 未提供
结局指标
主要结局
Quality of life questionnaires
时间窗: up to 12 months
National Eye Institute Visual Function Questionnaire (NEI-VFQ-25 - Italian Version, Jan 2003) Glaucoma Symptom Scale (GSS - Italian Version, April 2011)
次要结局
未报告次要终点