Project "XCHANGE" Non-Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28,812
- 主要终点
- Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio
研究概览
简要总结
Non-interventional study to obtain real life data from the treatment with Xalatan and Xalacom in Germany and to assess the long-term efficacy and tolerability under routine conditions. Data were entered into an electronic case report form.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with ocular hypertension or glaucoma, defined by SmPC
排除标准
- •defined by SmPC
结局指标
主要结局
Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio
时间窗: Baseline, 1 year, 2 years, and 3 years
Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).
Change From Baseline in Intraocular Pressure (IOP)
时间窗: Baseline, 1 year, 2 years, and 3 years
Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months).
Aulhorn Stage (Visual Field Defects)
时间窗: Baseline, 1 year, 2 years, and 3 years
Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed.
Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio
时间窗: Baseline, 1 year, 2 years, and 3 years
Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).
次要结局
- Subject Assessment of Satisfaction With Xalatan® Treatment(Baseline, 1 year, 2 years, and 3 years)
- Subject Self-care: Application of Eye Drops(Baseline, 1 year, 2 years, and 3 years)
- Reasons for Discontinuation From Study(January 2000 through December 2008)
- Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment(Baseline up to 3 years)
- Investigator Assessment of Xalatan® Efficacy(Baseline, 1 year, 2 years, and 3 years)
- Visual Acuity (Visus)(Baseline, 1 year, 2 years, and 3 years)
- Investigator Assessment of Tolerability of Xalatan® Treatment(Baseline up to 3 years)
- Visual Impairment Due to Glaucoma(Baseline, 1 year, 2 years, and 3 years)
- Reasons for Changes in Glaucoma Therapy(January 2000 through December 2008)