Influence of Pupillary Behavior During Eye Surgery on Morphological and Functional Outcome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- pupillary movement
研究概览
简要总结
Pupillary movement during eye surgery can be a challenge for eye surgeons. Despite the risk of intraocular lens damage and malpositioning due to mechanical manipulation1, iris manipulation may lead to a significant elevation of cytokines in the aqueous humor and an increase of postoperative inflammation2, 3. Iris damage is also known to lead to an increase of prostaglandin production which will not only lead to an increase of inflammation but also has an impact on intraoperative miosis4. This leads to the assumption that postoperative inflammation can be related to intraoperative pupillary movements due to the same leading cause of an increase of inflammatory mediators. Tracking intraoperative pupillary movements might therefore be a helpful tool for the prediction of postoperative PCME and could have an impact on therapeutic decisions after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presence of significant cataract,
- •written consent.
- •presence of other ocular conditions requiring surgery such as: degenerative corneal disease, retinal conditions (i.e. macular pucker)
排除标准
- •reasons for poor video quality (such as poor red reflex due to abnormal anatomy)
结局指标
主要结局
pupillary movement
时间窗: during surgery
Analyzing the extend of pupil movement during cataract surgery
IOL rotation
时间窗: Video taken immediately postoperative and 2-4 weeks postoperative
The rotation of the IOL directly after surgery and a 2-4 weeks postoperative when the second eye is operated.
retinal thickness
时间窗: at baseline and 2-4 weeks postoperative
OCT Scan to measure retinal thickness at baseline and 2-4 weeks after surgery
次要结局
未报告次要终点
研究者
Yosuf El-Shabrawi
Prim. Univ. Prof. Dr. Yosuf El-Shabrawi
Klinikum Klagenfurt am Wörthersee