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临床试验/NCT02359149
NCT02359149已完成不适用

Intravitreal Injections by Nurses or Physicians: a Randomized Controlled Trial Comparing Efficacy, Patient Satisfaction and Health Economy

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

intravitreal injections with anti-VEGF agents given by a physician

干预措施: Anti-VEGF agents (Drug)

nurse

Experimental

intravitreal injections with anti-VEGF agents given by a nurse

干预措施: intravitreal injections given by a nurse (Procedure)

nurse

Experimental

intravitreal injections with anti-VEGF agents given by a nurse

干预措施: Intravitreal injections (Procedure)

nurse

Experimental

intravitreal injections with anti-VEGF agents given by a nurse

干预措施: Anti-VEGF agents (Drug)

physician

Active Comparator

intravitreal injections with anti-VEGF agents given by a physician

干预措施: intravitreal injections given by a physician (Procedure)

physician

Active Comparator

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)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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