临床研究使用新的超声乳化系统和手术眼内压控制。

Clinical study using a new phacoemulsification system with surgical intraocular pressure control.

机构信息

From the Carolina Eyecare Physicians (Solomon), Charleston, South Carolina, Alcon Research, Ltd. (Fanney), Irvine, California, and the Eye Institute of Utah (Cionni), Salt Lake City, Utah, USA; Complejo Hospitalario Universitario Orense (Lorente), Orense, Spain.

出版信息

J Cataract Refract Surg. 2016 Apr;42(4):542-9. doi: 10.1016/j.jcrs.2016.01.037.

DOI:10.1016/j.jcrs.2016.01.037

PMID:27113876

Abstract

PURPOSE

To compare cumulative dissipated energy (CDE), aspiration fluid used, and aspiration time during phacoemulsification cataract extraction using 2 surgical configurations.

SETTING

Two clinical sites in the United States and 1 in Spain.

DESIGN

Prospective randomized clinical case series.

METHODS

For each patient, the first eye having surgery was randomized to the active-fluidics configuration (Centurion Vision System with Active Fluidics, 0.9 mm 45-degree Intrepid Balanced tip, and 0.9 mm Intrepid Ultra infusion sleeve) or the gravity-fluidics configuration (Infiniti Vision System with gravity fluidics, 0.9 mm 45-degree Mini-Flared Kelman tip, and 0.9 mm Ultra infusion sleeve). Second-eye surgery was completed within 14 days after first-eye surgery using the alternate configuration. The CDE, aspiration fluid used, and aspiration time were compared between configurations, and adverse events were summarized.

RESULTS

Patient demographics and cataract characteristics were similar between configurations (100 per group). The CDE was significantly lower with the active-fluidics configuration than with the gravity-fluidics configuration (mean ± standard error, 4.32 ± 0.28 percent-seconds) (P < .001). The active-fluidics configuration used significantly less aspiration fluid than the gravity-fluidics configuration (mean 46.56 ± 1.39 mL versus 52.68 ± 1.40 mL) (P < .001) and required significantly shorter aspiration time (mean 151.9 ± 4.1 seconds versus 167.6 ± 4.1 seconds) (P < .001). No serious ocular adverse events related to the study devices or device deficiencies were observed.

CONCLUSION

Significantly less CDE, aspiration fluid used, and aspiration time were observed with the active-fluidics configuration than with the gravity-fluidics configuration, showing improved surgical efficiency.

FINANCIAL DISCLOSURES

Drs. Solomon and Cionni are consultants to Alcon Research, Ltd., and received compensation for conduct of the study. Dr. Lorente received compensation for clinical work in the study. Mr. Fanney is an employee of Alcon Research, Ltd.

摘要

目的

比较两种手术设置下超声乳化白内障吸除术中的累积耗散能量（CDE）、使用的抽吸液量和抽吸时间。

设置

美国两个临床地点和西班牙一个临床地点。

设计

前瞻性随机临床病例系列研究。

方法

每例患者的第一只眼随机分配到主动流控配置（Centurion 视觉系统配主动流控、0.9 毫米 45 度 intrepid 平衡尖端和 0.9 毫米 intrepid Ultra 输注套管）或重力流控配置（Infiniti 视觉系统配重力流控、0.9 毫米 45 度 Mini-Flared Kelman 尖端和 0.9 毫米 Ultra 输注套管）。第一只眼手术后 14 天内完成第二只眼手术，使用另一种配置。比较两种配置之间的 CDE、使用的抽吸液量和抽吸时间，并总结不良事件。

结果

配置之间患者人口统计学特征和白内障特征相似（每组 100 例）。与重力流控配置相比，主动流控配置的 CDE 明显较低（平均 ±标准误差，4.32 ± 0.28 秒）（P < 0.001）。主动流控配置使用的抽吸液量明显少于重力流控配置（平均 46.56 ± 1.39 毫升比 52.68 ± 1.40 毫升）（P < 0.001），抽吸时间也明显更短（平均 151.9 ± 4.1 秒比 167.6 ± 4.1 秒）（P < 0.001）。未观察到与研究设备或设备缺陷相关的严重眼部不良事件。