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内置流体压力传感器手柄对超声乳化效果的影响:一项多中心前瞻性对比研究。

Impact of a handpiece with a built-in fluidics pressure sensor on phacoemulsification: a multicentre prospective comparative study.

机构信息

Université Paris Cité, Ophtalmologie, Hôpital Cochin, Paris, France

Université Paris Cité, Ophtalmologie, Hôpital Cochin, Paris, France.

出版信息

BMJ Open Ophthalmol. 2023 Nov;8(1). doi: 10.1136/bmjophth-2023-001431.

Abstract

OBJECTIVE

We assessed whether the immediate pressure adjustments provided by a phacoemulsification handpiece with a built-in pressure sensor (Active Sentry, AS) could decrease the amount of energy delivered in the eye during cataract surgery.

METHODS AND ANALYSIS

The Study of Active Sentry in Cataract Surgery was a multicentre prospective clinical trial. The Centurion system (Alcon Labs) was used and we compared phacoemulsifications performed with the AS handpiece with procedures using a sensor placed in the phacoemulsifier (non-AS). The primary outcome measure was the cumulative dissipated energy (CDE) used during the procedures. The secondary outcome measures were the total, longitudinal and torsional ultrasound (US) times, the duration of the surgery and the amount of fluid used during the surgeries.

RESULTS

The study analysed 1432 (800 AS and 632 non-AS) procedures. The mean patient age was 72.4±10.0 years. The median CDE was respectively 6.3 (IQR 3.5-9.9) and 6.7 (IQR 4.5-11.5) with and without AS (p=0.0001). The median US time was, respectively, 48.0 s (IQR 34.0-68.0) and 55.0 s (IQR 38.0-80.0) with and without AS (p<0.0001). Torsional and longitudinal US times were reduced with AS. The median duration of the procedure was, respectively, 9.0 min (IQR 7.0-12.0) and 10.0 min (IQR 7.0-13.0) (p=0.0002) with and without AS. The median balanced salt solution volume used was 52.0 cm (IQR 41.0-72.0) and 57.0 cm (IQR 42.0-81.0) with and without AS (p=0.0018).

CONCLUSION

The phacoemulsifications performed with a pressure sensor built in the handpiece delivered less energy in the eye and were shorter.

TRIAL REGISTRATION NUMBER

NCT04732351.

摘要

目的

评估具有内置压力传感器的超声乳化仪(Active Sentry,AS)即时压力调整是否可以减少白内障手术中眼内传递的能量。

方法与分析

白内障手术中的 Active Sentry 研究是一项多中心前瞻性临床试验。使用 Centurion 系统(Alcon Labs),我们比较了使用 AS 手柄进行的超声乳化术与在超声乳化仪中放置传感器(非 AS)进行的手术。主要结局测量指标为手术过程中累积耗散能量(CDE)。次要结局测量指标包括总超声(US)时间、纵向 US 时间、扭转 US 时间、手术持续时间以及手术过程中使用的液体量。

结果

该研究分析了 1432 例(800 例 AS 和 632 例非 AS)手术。患者平均年龄为 72.4±10.0 岁。有和无 AS 时的中位 CDE 分别为 6.3(IQR 3.5-9.9)和 6.7(IQR 4.5-11.5)(p=0.0001)。有和无 AS 时的中位 US 时间分别为 48.0 s(IQR 34.0-68.0)和 55.0 s(IQR 38.0-80.0)(p<0.0001)。使用 AS 时,扭转和纵向 US 时间均缩短。有和无 AS 时手术持续时间的中位数分别为 9.0 min(IQR 7.0-12.0)和 10.0 min(IQR 7.0-13.0)(p=0.0002)。有和无 AS 时,中位平衡盐溶液体积分别为 52.0 cm(IQR 41.0-72.0)和 57.0 cm(IQR 42.0-81.0)(p=0.0018)。

结论

内置压力传感器的超声乳化仪在眼内传递的能量更少,手术时间更短。

试验注册号

NCT04732351。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/732c/10661016/6a6336a2182a/bmjophth-2023-001431f01.jpg

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