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
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.
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.
J Cataract Refract Surg. 2014 Dec;40(12):2057-66. doi: 10.1016/j.jcrs.2014.03.034. Epub 2014 Nov 24.
To evaluate the effectiveness of a hydrogel sealant versus a suture in preventing fluid egress after wound leakage in cataract surgery.
Twenty-four ophthalmic clinical practices in the United States.
Prospective randomized parallel-arm controlled multicenter subject-masked study.
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.
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).
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.
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。
美国24家眼科临床机构。
前瞻性随机平行臂对照多中心受试者盲法研究。
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。
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）。
在本研究中，97.6%的CCI在白内障手术后发生渗漏。水凝胶密封剂安全有效，在术中处理经Seidel试验发现有渗漏的CCI以及预防术后液体流出方面优于缝线。
