Samuel Masket1, John A Hovanesian2, Jeffrey Levenson2, Farrell Tyson2, William Flynn2, Michael Endl2, Parag A Majmudar2, Satish Modi2, Ralph Chu2, Michael B Raizman2, Stephen S Lane2, Terry Kim2. 1. 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. Electronic address: sammasket@aol.com. 2. 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.
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.
RCT Entities:
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.
Authors: Fang Chen; David C Mundy; Peter Le; Youngyoon Amy Seo; Caitlin M Logan; Gabriella Maria Fernandes-Cunha; Chris A Basco; David Myung Journal: Transl Vis Sci Technol Date: 2022-10-03 Impact factor: 3.048
Authors: Jackie Tan; Leslie John Ray Foster; Frank James Lovicu; Stephanie Louise Watson Journal: J Cataract Refract Surg Date: 2022-03-01 Impact factor: 3.528
Authors: Gabriella Maria Fernandes-Cunha; Karen Mei Chen; Fang Chen; Peter Le; Ju Hee Han; Leela Ann Mahajan; Hyun Jong Lee; Kyung Sun Na; David Myung Journal: Sci Rep Date: 2020-10-07 Impact factor: 4.996