EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/422211
EW RESIDENTS 62 December 2014 by Megan Ridley-Lane, MD, Brad Kligman, MD, Kathleen Oktavec, MD, Gregory Stein, MD, Larissa Habib, MD, Dov Sebrow, MD, Albert Hazan, MD, James Lin, MD, Stacy Scofield, MD, Bryan J. Winn, MD, and Jonathan S. Chang, MD, Department of Ophthalmology, Edward S. Harkness Eye Institute, Columbia University T he majority of U.S. oph- thalmologists now perform cataract surgery using clear corneal incisions (CCIs). 1 These incisions are associ- ated with a bloodless surgical field, easily achieved topical anesthesia, faster recoveries, and less surgical- ly induced astigmatism compared to large-incision scleral or corneal incisions. However, the routine use of CCIs has raised questions around wound integrity, especially as many surgeons now limit wound closure to stromal hydration rather than suturing. In the December issue of the Journal of Cataract & Refractive Surgery (JCRS), Masket et al. propose an alternative to current wound closure methods in their study, "Randomized comparison of a hydrogel sealant versus sutures for prevention of fluid egress following cataract surgery." 2 The authors de- scribe the potential complications of stromal hydration for wound closure including its transient effect, mask- ing of underlying CCI structural problems, prolonging surgery time by 1 minute, and the possibility of causing a Descemet's detachment, among others. They cite sutures as the current gold standard for ensur- ing closure of CCIs, and note sutur- ing is imperfect, with problems such as increased surgical time, need for postoperative removal, induction of astigmatism, foreign body sensation, and subconjunctival hemorrhage. In a prospective, randomized, con- trolled, multicenter, subject- masked study, the authors compared the use of sutures with the use of a hydrogel sealant, ReSure Sealant (Ocular Therapeutix, Bedford, Mass.), in corneal wound closure for patients undergoing cataract surgery. The ReSure Sealant is composed of polyethylene glycol (PEG) trilysine, buffering salts, and water. According to the authors, ReSure forms a clear seal after application to a dry wound surface. Prior studies have found other types of hydrogel sealants to be both effective and biocompatible in wound closures. 3 Of note, this study was sponsored by Ocular Ther- apeutix, the company that produces ReSure Sealant, and several of the study authors are consultants and shareholders of Ocular Therapeutix. This conflict of interest should be taken into account when interpret- ing the results of this study. The study enrolled 583 patients from 24 testing centers. To be eligible for randomization, a patient had to have no confound- ing ocular pathologies and undergo "uneventful" cataract surgery with CCIs and at the time of closure demonstrate wound leakage either with minimal or no provocation. The study defined minimal Review of "Randomized comparison of a hydrogel sealant versus sutures for prevention of fluid egress following cataract surgery" Randomized comparison of a hydrogel sealant versus sutures for prevention of fluid egress following cataract surgery Samuel Masket, MD, John A. Hovanesian, MD, Jeffrey Levenson, MD, Farrell Tyson, MD, William Flynn, MD, Michael Endl, MD, Parag A. Majmudar, MD, Satish Modi, MD, Ralph Y. Chu, MD, Michael B. Raizman, MD, Stephen S. Lane, MD, Terry Kim, MD J Cataract Refract Surg (Dec.) 2014;40:2057–2066 Purpose: To evaluate the effectiveness of a hydrogel sealant in preventing fluid egress after wound leakage following cataract surgery, compared to a suture. Setting: 24 ophthalmic clinical practices in the United States. Design: Prospective, randomized, parallel arm, controlled, multicenter, subject-masked study. Methods: Healthy patients undergoing uncomplicated clear corneal cataract surgery were eligible for the study. Spontaneous and provoked fluid egress using a Calibrated Force Gauge were evaluated at the time of cataract surgery, and eyes demonstrating leakage were randomized to receive either the hydrogel sealant (ReSure Sealant) or a nylon suture at the main incision site. Incision leakage was re-evaluated at 1, 3, 7, and 28 days postoperatively. Results: 488/500 patients exhibited leakage at the time of cataract surgery. 48.8% leaked spontaneously, and 97.6% of all incisions leaked with ≤1.0 ounce force. After randomization, 4.1% (12/295) of eyes in the sealant group and 34.1% (60/176) in the suture group exhibited leakage of the wound with provocation (p<0.0001). The overall incidence of adverse ocular events reported for subjects treated with the sealant was significantly lower than for subjects treated with suture (p<0.05). Conclusions: Ninety-eight percent of clear corneal incisions in this study exhibited wound leakage after cataract surgery. Results from this study demonstrated that the hydrogel sealant was safe and effective and superior to a suture for the intraoperative management of clear corneal incisions with a wound leak demonstrated by Seidel testing, and for prevention of postoperative fluid egress following cataract surgery. EyeWorld journal club ReSure Sealant (Ocular Therapeutix) is now FDA approved and available to U.S. ophthalmologists. The first large clinical trial evaluating this product is reported in this month's JCRS, and I invited the Columbia residents to review this paper. –David F. Chang, MD, chief medical editor Bryan J. Winn, MD, residency program director, Department of Ophthalmology, Columbia University Medical Center Jonathan S. Chang, MD, assistant professor of ophthalmology, Columbia University Medical Center continued on page 64 provocation as force up to 1 ounce, which was applied to the sclera adja- cent to the wound with a Calibrated Force Gauge (Ocular Therapeutics), an instrument developed and vali- dated by the research study group. 4 The study randomized 488 eyes in a 3 to 1 ratio into either wound clo- sure with ReSure Sealant or wound closure with a single 10-0 buried nylon suture tied in a 3-1-1 fashion. In the body of the manuscript, the authors state that no stromal hydra- tion was performed after random- ization, while the published flow sheet states that "stromal hydration as needed" was performed in both groups, a point that may confound the results. The primary endpoint was a positive Seidel test with spontaneous leakage, or when the wound was subjected to up to 1 ounce of force with the Calibrated Force Gauge from 1 hour to 7 days after suture or sealant placement. If leakage was noted during follow-up, further intervention was at the surgeon's discretion. Investigators performed postoperative follow-up evaluations at 1 hour, 1 day, 3 days, 7 days, 14 days, and 28 days. Follow-up evalu- ation included a Seidel test up until the day 7 examination, as well as