Hydrogel sealant versus sutures to prevent fluid egress after cataract surgery.
Samuel Masket, John A Hovanesian, Jeffrey Levenson, Farrell Tyson, William Flynn, Michael Endl, Parag A Majmudar, Satish Modi, Ralph Chu, Michael B Raizman, Stephen S Lane, Terry Kim
Author Information
Samuel Masket: 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.
John A Hovanesian: 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.
Jeffrey Levenson: 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.
Farrell Tyson: 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.
William Flynn: 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.
Michael Endl: 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.
Parag A Majmudar: 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.
Satish Modi: 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.
Ralph Chu: 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.
Michael B Raizman: 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.
Stephen S Lane: 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.
Terry Kim: 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.
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.
