Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- NEI VFQ 25 quality of life score change
研究概览
简要总结
Quality of Life assessment before and after various glaucoma surgery (traditional and microinvasive (MIGS)).
详细描述
Patients qualified for glaucoma surgical procedure fill in QoL questionnaire (NEI VFQ 25) at baseline (pre-operatively) and 3 months after glaucoma surgery. Additional data will be collected such as demographic data and medical data, visual acuity, intraocular pressure, number of glaucoma medications, stage of glaucoma based on visual field assessment, medical ophthalmic history, intra and postoperative complications, postoperative interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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 qualified for glaucoma surgery in Military Institute of Medicine - based on following Inclusion Criteria:
- •all glaucoma types with characteristic glaucoma changes (biomicroscopic ,visual field) with documented glaucoma progression
- •patients not tolerating antiglaucoma medications,
- •patients with poor compliance
- •progression in visual field
排除标准
- •active inflammatory disease
- •pregnancy
- •mental disease or emotional instability
- •general steroid therapy
- •inability to fill in the questionnaire
研究组 & 干预措施
traditional glaucoma surgery
glaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy
干预措施: Glaucoma surgery (Procedure)
microinvasive glaucoma surgery (MIGS)
glaucoma procedures such as : canaloplasty (traditional, ABiC, modified), iStent, XEN, Cypass,Hydrus- and with any other microinvasive IOP reducing device
干预措施: Glaucoma surgery (Procedure)
结局指标
主要结局
NEI VFQ 25 quality of life score change
时间窗: baseline (0-30 days; pre-operative) and three months after surgery
NEI VFQ 25 baseline and 3 months after surgery
次要结局
未报告次要终点
研究者
Marek Rekas
płk prof. Marek RĘKAS, MD, PhD
Military Institute od Medicine National Research Institute