跳至主要内容
临床试验/NCT05397743
NCT05397743Unknown不适用

A Prospective Study About Global, Psychological and Visual Quality of Life After an Eye Surgical Removal (Enucleation or Evisceration)

Centre Hospitalier Universitaire de Besancon2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Score VFQ 25 score up to 3 months after surgery

研究概览

简要总结

Studies have shown that health-related quality of life (HRQOL) was worse among patients who underwent surgical eye removal compared to the general population in Denmark.

A third of eye amputated patients suffered from anxiety and depression. Most of the available evidence on the subject is based on retrospective studies that interviewed patients several years after surgery, which can potentially introduce biases.

Moreover, in the literature, there are no data concerning postoperative psychological and visual impact.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Patient who underwent an eye removal surgery: evisceration, enucleation or exenteration

排除标准

  • Patient who underwent bilateral eye removal surgery

结局指标

主要结局

Score VFQ 25 score up to 3 months after surgery

时间窗: Month 3

100 = Best score, 0 = Worst possible score

次要结局

  • PSS score up to 3 months after surgery(Month 3)
  • SF-36 score up to 3 months after surgery(Month 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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