Intravitreal Injections by Nurses or Physicians: a Randomized Controlled Trial Comparing Efficacy, Patient Satisfaction and Health Economy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- change in visual acuity
研究概览
简要总结
Anti-VEGF agents are given for a variety of previously untreatable eye diseases. The last years indications for their use and consequently the number of patients needing treatment, have been increasing. Most patients require multiple injections. This has resulted in many eye departments administering thousands of injections per year, also at St Olavs University Hospital Trondheim. To cope with this increase in workload, it would be helpful if injections would be given not only by the physicians but also by the nurses. This study's objective is to compare efficiency, patient satisfaction and cost per patient of injections given by nurses and physicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •referred to the eye clinic for treatment of age related macular degeneration, diabetes retinopathy or retinal vein occlusion with anti-vascular endothelium growth factor
- •Ability to provide written informed consent
- •ability to comply with study assessments for the full duration of the study
排除标准
- 未提供
研究组 & 干预措施
physician
intravitreal injections with anti-VEGF agents given by a physician
干预措施: Anti-VEGF agents (Drug)
nurse
intravitreal injections with anti-VEGF agents given by a nurse
干预措施: intravitreal injections given by a nurse (Procedure)
nurse
intravitreal injections with anti-VEGF agents given by a nurse
干预措施: Intravitreal injections (Procedure)
nurse
intravitreal injections with anti-VEGF agents given by a nurse
干预措施: Anti-VEGF agents (Drug)
physician
intravitreal injections with anti-VEGF agents given by a physician
干预措施: intravitreal injections given by a physician (Procedure)
physician
intravitreal injections with anti-VEGF agents given by a physician
干预措施: Intravitreal injections (Procedure)
结局指标
主要结局
change in visual acuity
时间窗: 1 year
Mean change in visual acuity from baseline to 12 months, tested on ETDRS letter chart
次要结局
- incidence of ocular adverse events(from baseline to 12 months)
- patient satisfaction(12 months)
