跳至主要内容
临床试验/NCT06712758
NCT06712758招募中不适用

Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients. Prospective, Investigator Initiated and Observational Case Series

Visionair Oogzorg1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
1
主要终点
Complication rate during cataract surgery

研究概览

简要总结

You were selected to participate in this observational study because you suffer from glaucoma and cataracts. For the cataract you will have cataract surgery. This study will not affect your treatment, it will only collect data on what is performed before, during and after the procedure.

The aim of this data collection is to demonstrate the safety of a new generation of cataract surgical devices in patients who also suffer from glaucoma. They are glaucoma patients who have an increased sensitivity to eye pressure increases both during and after surgery. The new surgical device makes it possible to safely perform cataract surgery under low pressures. This could, at least theoretically, provide an advantage for patients who also suffer from glaucoma.

详细描述

Cataract surgery is a highly standardized procedure. However a new phacoemulsification system "Quatera 700" has been developed by Carl Zeiss Meditec. The system has a unique patented QUATTRO Pump that directly controls infusion and aspiration and enables a synchronous change in both. It has four membranes, which directly regulate infusion and aspiration and maintain a pre-set intraocular pressure (IOP), resulting in a stable anterior chamber during the surgery. The membranes are activated by pneumatic pressure regulated by sensors that measure infusion and aspiration flows which allows the system to determine and compensate for incisional leakage as well. This innovative pump system allows surgeons to significantly decrease the intra-ocular pressure during cataract surgery. In respect to competitive devices on the market, the Quatera system is able to operate with pressure four times lower than average. Especially in glaucoma patients (patients suffering from optic nerve head damage due to elevated intraocular pressures), performing surgery with lower intra-ocular pressures would help in avoiding extra nerve fiber layer damage and overall safety of the surgery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with glaucoma that are diagnosed with age-related cataract

排除标准

  • Unwilling to sign informed consent
  • Functionally monophtalmic patient
  • Endothelial dystrophy
  • Active uveitis
  • Known corticosteroid responder
  • Presence of uncontrolled systemic disease

结局指标

主要结局

Complication rate during cataract surgery

时间窗: Month 1

Complication rate during cataract surgery

次要结局

  • Best corrected visual acuity(Month 1)
  • Intraocular pressure(1 month)
  • Retinal nerve fiber layer thickness(1 year)
  • Visual field mean deviation(Month 1)

研究者

发起方
Visionair Oogzorg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Koen Willekens

Professor Doctor

Visionair Oogzorg

研究点 (1)

Loading locations...

相似试验