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比较 4 种预装式人工晶状体输送系统对角膜切口扩大的影响。

Comparative assessment of the corneal incision enlargement of 4 preloaded IOL delivery systems.

机构信息

From Alcon Vision LLC (Liu, Wolfe, Hernandez), Fort Worth, Texas, USA; and the Department of Ophthalmology, Goethe-University (Kohnen), Frankfurt, Germany.

出版信息

J Cataract Refract Surg. 2020 Jul;46(7):1041-1046. doi: 10.1097/j.jcrs.0000000000000214.

Abstract

PURPOSE

To compare the corneal incision size enlargement after intraocular lens (IOL) implantation of a new, automated, preloaded delivery system, AutonoMe (system A), vs that of 3 other available preloaded systems (UltraSert [system U], Vivinex iSert [system V], and Tecnis iTec [system T]).

SETTING

Alcon Vision LLC, Fort Worth, Texas, USA.

DESIGN

Experimental study.

METHODS

Human cadaver eyes were randomly assigned to receive IOLs implanted with the preloaded delivery devices. Corneal incisions were imaged using optical coherence tomography, and incision sizes were measured using an Asico incision gauge before and after IOL delivery. Differences in mean incision enlargement between delivery devices were evaluated using a paired t test.

RESULTS

System A (mean ± standard deviation, 0.29 ± 0.03 mm) and system U (0.29 ± 0.03 mm) had the smallest mean incision size enlargement compared with system T (0.31 ± 0.03 mm) and system V (0.36 ± 0.06 mm). System V had the largest corneal incision enlargement and was significantly larger than system A (P = .001), system U (P = .001), and system T (P = .002). System A was noninferior to system U; the paired difference in corneal incision enlargement between the devices was -0.01 ± 0.04 mm (90% CI, -0.03 to 0.01).

CONCLUSIONS

The new system A preloaded delivery system provided smaller corneal incision enlargement compared with system T or system V and was noninferior to system U.

摘要

目的

比较新型自动预装输送系统 AutonoMe(系统 A)与其他 3 种已上市的预装输送系统(UltraSert [系统 U]、Vivinex iSert [系统 V]和 Tecnis iTec [系统 T])在人工晶状体(IOL)植入术后角膜切口扩大的情况。

地点

美国得克萨斯州沃思堡市爱尔康视力公司。

设计

实验研究。

方法

将人尸体眼球随机分配,使用预装输送装置植入 IOL。使用光相干断层扫描对角膜切口进行成像,使用 Asico 切口计在 IOL 输送前后测量切口大小。使用配对 t 检验评估输送装置之间平均切口扩大差异。

结果

与系统 T(0.31 ± 0.03 mm)和系统 V(0.36 ± 0.06 mm)相比,系统 A(平均值 ± 标准差,0.29 ± 0.03 mm)和系统 U(0.29 ± 0.03 mm)的平均切口扩大最小。系统 V 的角膜切口扩大最大,明显大于系统 A(P =.001)、系统 U(P =.001)和系统 T(P =.002)。系统 A 非劣效于系统 U;两种设备之间角膜切口扩大的配对差值为-0.01 ± 0.04 mm(90%CI,-0.03 至 0.01)。

结论

新型系统 A 预装输送系统与系统 T 或系统 V 相比,角膜切口扩大较小,与系统 U 非劣效。

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