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临床试验/NCT04732351
NCT04732351已完成不适用

Observational Multicenter Registry to Assess the Enefits of Active Sentry Handpiece During Cataract Surgery With the Centurion Phacoemulsifier (SASCA)

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2021年5月5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
5,000
试验地点
1
主要终点
Mean CDE (Cumulated Dissipated Energy)

研究概览

简要总结

Each new generation of phacoemulsification system has aimed to optimize the control of fluidics and the delivery of energy during phacoemulsification. Nicoli CM et al., (J Cataract Refract Surg 2016;42:157-162) suggested a better anterior chamber stability when using an active fluidics system. Malik PK et al., (Eye and Vision 2017;4:22) showed that using an IOP based phacoemulsification system in association with the use of an Intrepid balanced tip provides a reduction in CDE (Cumulated Dissipated Energy and EFU (Estimated Fluid Usage). It has also been shown that a lower CDE provides obvious benefits: less endothelium cells damages and lower complication rates (Mady MA et al., Clin.Ophthalmol. 2012; 6:503-10).

The latest technologies, i.e. the Active Sentry Handpiece and Hybrid tips, have been introduced to further improve the safety of phacoemulsification. The Active Sentry system has moved pressure sensors closer to the operated eye, hence further reducing the risk of surge during procedures. (Thorne A et al. Phacoemulsifier occlusion break surge volume reduction, J Cataract Refract Surg. 2018;44:1491-1496). The Hybrid tips have been designed to prevent posterior capsule rupture in the event of contact with the capsule.

This new technology allows phacoemulsification procedures under reduced infusion pressures and a "high-vacuum - low energy" strategy which may lead to a safer procedure.

Data from this study will try to demonstrate that cataract surgeries with Active Sentry will need less CDE and therefore may be safer, due to the surge effects decrease. This CDE parameter will be analysed according to differents subgroups: Presence of hybrid tip or balanced tip, cataract score based on the WHO nuclear grading recommendation (Thylefors B et al., (2002) The WHO Cataract Grading Group, Ophthalmic Epidemiology, 9:2, 83-95) The recent experiences conducted in real world condition in different sites have suggested that Centurion with AS was able to improved settings: maximum vacuum and UltraSound (US) time reduction and as a consequence a 20 to 30% CDE reduction.

研究设计

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

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

  • All consecutive patients undergoing unilateral or bilateral cataract surgery with the Centurion phacoemulsifier, with the ability to give informed consent.
  • Patients will undergo the cataract surgery with or without the Active Sentry module and with or without hybrid tip according to centers practice.
  • Patients will undergo a cataract scoring (nuclear grade 1 to 3) prior surgery as described in the WHO recommendation:

排除标准

  • Patients with :
  • pupil dilation <5mm
  • zonular defects
  • corneal opacities

结局指标

主要结局

Mean CDE (Cumulated Dissipated Energy)

时间窗: The day of the cataract procedure

Mean CDE measured by the phacoemulsifier in different groups according to baseline patients and/or eyes characteristics (nuclear cataract grading etc...)

次要结局

  • Mean total procedure duration(The day of the cataract procedure)
  • Frequency of adverse events(The day of the procedure)
  • Mean procedure settings(The day of the procedure)
  • Mean total Ultrasound time (US time)(The day of the procedure)
  • Mean BSS volume(The day of the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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