跳至主要内容
临床试验/NCT05196139
NCT05196139已完成不适用

Visual Outcome After Vitrectomy With Subretinal tPA Injection to Treat Submacular Hemorrhage Secondary to Age-related Macular Degeneration or Macroaneurysm

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
Surgical adverse events

研究概览

简要总结

evaluate the safety of Eva surgical system

详细描述

The purpose of this retrospective study is to evaluate the safety and clinical results using this surgical technique when performed using the EVA surgical system and associated instrumentation and disposable surgical equipment

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • patients with VTX subretinal tPA ( + phaco)
  • patients with submacular bleeding

排除标准

  • 未提供

结局指标

主要结局

Surgical adverse events

时间窗: postoperative visit on day 1

Surgical adverse events or issues that were recorded in the surgical report

post-operative best corrected visual acuity

时间窗: 6 weeks after surgery

The post-operative BCVA will be taken from the latest visit after the surgical procedure

pre-operative best corrected visual acuity

时间窗: pre surgery

• The pre-operative BCVA will be taken from the visit when the indication for the surgery was set

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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