Eyeworld

EW CATARACT 40 September 2014 by Maxine Lipner EyeWorld Senior Contributing Writer fact that many surgeons today are not using them often. "When you don't suture, you lose your skill," he said. "The other issue is when you look at what a suture is doing, it is compressing two sides of the wound together, but it's not actually sealing that wound." However, the ReSure Sealant completely covers the length of the wound. "I think you're getting a better seal of the wound with something like a sealant compared to a suture," Dr. Kim said. "Ironically, while the study was designed to show non-inferiority of the sealant compared to suture, in- vestigators found the ReSure Sealant to be statistically superior to suture," he said. Dr. Kim views the sealant as something that should be on the shelves of every operating room because practitioners never know when they are going to encounter a scenario in which a better means of wound closure may be needed. Suturing can be a real hassle, he said. "The OR staff has to find the suture and open it, then the surgeon has to load, place, tie, cut, and bury the suture—this is something that could take several minutes," he said. Meanwhile, the ReSure Sealant takes less than 30 seconds to prepare and apply, Dr. Kim said. Popular uses There are many clinical scenarios that warrant the use of the ReSure Sealant, he thinks. Routine cataract surgery is one, as is the premium cataract channel. Premium patients are paying extra out-of-pocket for multifocal, accommodating, or toric lenses and have higher expectations for outcomes. "If you get a wound leak or a complication, the lens is not in the ideal position, or the refractive outcome is not what you want, these are the patients who are going to be more vocal and unhap- py," Dr. Kim said. "Because of the higher expectations I think that's an ideal scenario to use this." In addition, more complex cases, such as those in which a Malyugin ring (MicroSurgical Technology, Redmond, Wash.) or an iStent (Glaukos, Laguna Hills, Calif.) are inserted, may also benefit. "Any cases where the wound dynamics may be unusual or abnor- mal, such as high myopes or those with keratoconus, these are patients Eye Center, Durham, N.C. Rates of wound leaks with stromal hydration alone can reach 85%, he said. New results indicate that the recently approved ReSure Sealant (Ocular Therapeutix, Bedford, Mass.) is far more likely to prevent leaks than sutures. In the study, presented at the 2014 ASCRS•ASOA Symposium & Congress, the leak rate for the suture group was determined to be 34.1% compared to just 4.1% for the ReSure Sealant, Dr. Kim said. In the prospective trial, inves- tigators enrolled 488 eyes slated for cataract surgery at 24 sites. The aim was to compare any leakage with the ReSure Sealant to traditional sutures. In the study, a peer-reviewed ocular force gauge designed by Samuel Masket, MD, and John Hovanesian, MD, was used to help test for leaks. Only patients who showed signs of leakage were includ- ed in the study, Dr. Kim said. "At the end of the cataract surgery you had to use a fluorescein strip and do a Seidel test in the OR, and if the wound leaked sponta- neously then the patient qualified," Dr. Kim said. "If it didn't leak spon- taneously, a force gauge was placed on the posterior lip of the wound." Up to 1 ounce of force was used to see if the wound would leak. In cases where leakage was seen, patients were randomized to either the suture or the ReSure group. Then patients had to undergo a second wound leakage challenge with these same steps, Dr. Kim explained. "If they showed leakage with that, they were considered a primary endpoint failure," he said. "If they didn't leak, either spontaneously or with up to 1 ounce of force, they were considered successfully sealed with either suture or sealant." Sealant versus sutures When investigators compared leak- age rates here, they were surprised to find that this was 8 times higher for the suture group. "I didn't expect that," Dr. Kim said. Also, overall adverse events were significant- ly lower with the ReSure Sealant compared to the suture group, he said. Meanwhile, practitioners in the study considered the sealant easier to use, with 94% scoring it as "easy" or "very easy" to apply. Dr. Kim attributes part of the difficulty with the sutures to the J ust because a cataract wound appears closed does not mean it is necessarily leak proof, according to Terry Kim, MD, professor of ophthalmology, Duke University Sealant lowers cataract wound leakage rates Seal of superiority Patients in more complex surgical cases such as those involving the Malyugin ring may be good candidates for use of the ReSure Sealant. The ReSure Sealant can be applied in less than 30 seconds. Source (all): Terry Kim, MD

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