水凝胶密封剂与缝线在白内障手术后防止液体流出方面的比较

Hydrogel sealant versus sutures to prevent fluid egress after cataract surgery.

作者信息

Masket Samuel, Hovanesian John A, Levenson Jeffrey, Tyson Farrell, Flynn William, Endl Michael, Majmudar Parag A, Modi Satish, Chu Ralph, Raizman Michael B, Lane Stephen S, Kim Terry

机构信息

From Advanced Vision Care (Masket), Los Angeles, and Harvard Eye Associates (Hovanesian), San Clemente, California; Levenson Eye Associates (Levenson), Jacksonville, and Cape Coral Eye Center (Tyson), Cape Coral, Florida; Rashid, Rice & Flynn Eye Associates (Flynn), San Antonio, Texas; Fichte, Endl & Elmer Eyecare (Endl), Buffalo, and Seeta Eye Centers (Modi), Poughkeepsie, New York; Chicago Cornea Consultants, Ltd. (Majmudar), Hoffman Estates, Illinois; Chu Vision Institute (Chu), Bloomington, and Associated Eye Care (Lane), Stillwater, Minnesota; Ophthalmic Consultants of Boston (Raizman), Boston, Massachusetts; and Duke University Eye Center (Kim), Durham, North Carolina, USA.

出版信息

J Cataract Refract Surg. 2014 Dec;40(12):2057-66. doi: 10.1016/j.jcrs.2014.03.034. Epub 2014 Nov 24.

DOI:10.1016/j.jcrs.2014.03.034

PMID:25465686

Abstract

PURPOSE

To evaluate the effectiveness of a hydrogel sealant versus a suture in preventing fluid egress after wound leakage in cataract surgery.

SETTING

Twenty-four ophthalmic clinical practices in the United States.

DESIGN

Prospective randomized parallel-arm controlled multicenter subject-masked study.

METHODS

Healthy patients having uneventful clear corneal incision (CCI) cataract surgery were eligible for the study. Spontaneous and provoked fluid egress from wounds was evaluated at the time of surgery using a calibrated force gauge. Eyes with leakage were randomized to receive a hydrogel sealant (Resure) or a nylon suture at the main incision site. Incision leakage was reevaluated 1, 3, 7, and 28 days postoperatively.

RESULTS

Of 500 eyes, 488 had leakage at the time of cataract surgery. The leak was spontaneous in 244 cases (48.8%), and 488 (97.6%) of all incisions leaked with 1.0 ounce or less of applied force. After randomization, 12 (4.1%) of 295 eyes in the sealant group and 60 (34.1%) of 176 eyes in the suture group had wound leakage with provocation (P<.0001). The overall incidence of adverse ocular events was statistically significantly lower in the sealant group than in the suture group (P<.05).

CONCLUSIONS

In this study, 97.6% of CCIs leaked after cataract surgery. The hydrogel sealant was safe and effective and better than a suture for the intraoperative management of CCIs with leakage as seen on Seidel testing and for the prevention of postoperative fluid egress.

摘要

目的

评估水凝胶密封剂与缝线在预防白内障手术伤口渗漏后液体流出方面的有效性。

设置

美国24家眼科临床机构。

设计

前瞻性随机平行臂对照多中心受试者盲法研究。

方法

行顺利的透明角膜切口（CCI）白内障手术的健康患者符合本研究条件。手术时使用校准测力计评估伤口自发和诱发的液体流出情况。有渗漏的眼睛被随机分配在主切口部位接受水凝胶密封剂（Resure）或尼龙缝线。术后1、3、7和28天重新评估切口渗漏情况。

结果

500只眼中，488只在白内障手术时有渗漏。244例（48.8%）渗漏为自发的，所有切口中488例（97.6%）在施加1.0盎司或更小的力时发生渗漏。随机分组后，密封剂组295只眼中有12只（4.1%）、缝线组176只眼中有60只（34.1%）在激发试验时有伤口渗漏（P<0.0001）。密封剂组不良眼部事件的总体发生率在统计学上显著低于缝线组（P<0.05）。