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随机比较多中心研究评估了用于白内障手术的两个分散粘度手术装置.

Ekkehard Fabian1, Andrea Janeková2,3, Pablo de Arriba Palomero4

  • 1AugenCentrum - Augenklinik Rosenheim, Rosenheim, Germany.

Journal of cataract and refractive surgery
|November 24, 2025
PubMed
概括

Z-HYALCOAT眼科粘度外科设备 (OVD) 与HEALON EndoCoat OVD相比没有劣势. 这两种设备在三个月内在眼内压力峰值和安全性方面表现相似.

关键词:
白内障是什么?白内障是什么?白内障是什么?白内障手术是什么?白内障手术是什么?角膜内皮质的角膜内皮质眼内压力 眼内压力眼部炎症 眼部炎症眼科粘度外科设备 眼科粘度外科设备

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科学领域:

  • 眼科医生 眼科 眼科
  • 医疗器械 医疗器械
  • 临床试验 临床试验

背景情况:

  • 白内障手术需要专门的眼科粘度手术装置 (OVD) 来维持前腔空间.
  • 分散性OVD对于在发酵过程中保护角膜内皮至关重要.
  • 对比新的OVDs与已建立的OVDs的疗效和安全性对于临床实践至关重要.

研究的目的:

  • 为了比较试验中的分散性眼科粘度手术装置 (OVD),Z-HYALCOAT,与控制装置,HEALON EndoCoat.
  • 为了评估Z-HYALCOAT在控制眼内压力 (IOP) 的非劣势,在白内障手术后出现尖峰.
  • 在3个月的随访期内评估OVD的安全性和功能.

主要方法:

  • 一项前性,随机化,蒙面的多中心研究,涉及242名接受无并发性白内障手术的成年人.
  • 试验对象接受Z-HYALCOAT或HEALON EndoCoat作为唯一的OVD.
  • 主要终点是内血压≥30mmHg的发生率;次要终点包括裂纹灯发现,角膜内皮细胞密度 (ECD) 和不良事件.

主要成果:

  • 在手术后8小时,Z-HYALCOAT (11.2%) 和HEALON EndoCoat (17.0%) 组之间的IOP峰值 (≥30 mmHg) 没有显著差异.
  • 在裂纹灯检查和角膜内皮细胞密度下降3个月后观察到类似的结果.
  • 外科医生报告的设备功能对于两种OVD都是可比且有利的,不良事件和设备缺陷的发生率相似.

结论:

  • 在白内障手术后,Z-HYALCOAT证明与HEALON EndoCoat在IOP尖峰方面没有劣势.
  • 这两种眼科粘度手术器件的安全性和临床性能都相似.
  • 这项研究支持Z-HYALCOAT作为白内障手术的可行的替代分散OVD.