Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule: a Prospective Randomised Double-masked Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- endothelium cell loss
研究概览
简要总结
Cataract surgery is one of the most frequently performed surgical procedures worldwide. Since the introduction of phacoemulsification to remove the cataractous lens, risk and complication rates of cataract surgery decreased significantly.
The phacoemulsification technique utilizes a high-intensity ultrasound energy for the fragmentation and emulsification of the lens. One of the main complications during phacoemulsification, is damaging of the endothelium due to contact with lens fragments of the nucleus following turbulent flow of irrigating solution, resulting in corneal damage, inflammation of the endothelium and corneal edema.
In this study we want to evaluate the effect of the anterior capsule, gained by capsular rhexis, as a corneal shield during phacoemulsification on the corneal endothelium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 and older
- •Written informed consent prior to surgery
- •Moderate to severe nuclear or mixed cataract
排除标准
- •Corneal pathologies
- •Pregnancy
- •Patients with an increased surgical risk (i.e. patients with pseudoexfoliation syndrome, patients with the potential risk of intra-operative floppy iris syndrome)
研究组 & 干预措施
Study group
rhexis protection shield
干预措施: Rhexis protection shield (Procedure)
Control group
regular surgery
结局指标
主要结局
endothelium cell loss
时间窗: 1 year
Comparison of the lost endothelium cells in both groups
次要结局
- central corneal thickness(1 year)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Prim. Prof. Dr.
Vienna Institute for Research in Ocular Surgery