Eyeworld

NOV 2015

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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EW GLAUCOMA 68 November 2015 by Michelle Dalton EyeWorld Contributing Writer ment may not be as clear-cut, and a viable and modestly efficacious option is Trabectome, Dr. Rhee said (although non-MIGS procedures such as canaloplasty or deep sclerec- tomy should also be considered). Dr. Rhee considers cataract/MIGS in those with advanced disease, as it offers a safer option than traditional trabeculectomy. "The combined procedure reduces the IOP enough that it helps improve the safety profile of a trab, if we need to go there," he said. Dr. Samuelson, however, is reluctant to consider combined surgery in patients with severe cases unless compliance and tolerance of medications has been established. "There will be a role for that down the road as more devices get ap- proved and the regulatory handcuffs come off," he said. "I think many MIGS devices will eventually be used as standalone procedures." For example, Dr. Samuelson said the Ivantis Hydrus (Irvine, Calif.) provides two mechanisms of action that make it particularly attractive as a potential standalone device. Other transscleral MIGS procedures that will make the subconjunctival approach to glaucoma surgery safer, such as the Xen Gel Stent (AqueSys, Aliso Viejo, Calif.) or the InnFocus MicroShunt (Miami), are also being eagerly awaited for regulatory ap- proval, Dr. Samuelson said. Similar- ly, the CyPass (Transcend Medical, Menlo Park, Calif.) and the iStent Supra (Glaukos, Laguna Hills, Calif.) have the potential to be standalone procedures, there is also great po- tential for combining several of the MIGS procedures, Dr. Francis said. "We want to offer patients everything we can for IOP lowering short of a traditional filtering sur- gery," he said. Phakic patients and high pressures Most surgeons will shy away from MIGS procedures when the patient has high IOP, "which is a mistake because those patients actually tend to do very well" with combined procedures, Dr. Francis said. "If you start with a pressure of 30 mm Hg and your target is 18 mm Hg, you may meet that very readily with a MIGS plus cataract or a MIGS as a standalone procedure." Unresolved IOP in a phakic patient with visually significant cataract "should absolutely" be con- sidered for a combined procedure, Dr. Rhee said, even in patients with higher IOPs. "I pursue the potential of removing the cataract and doing cat- aract/glaucoma surgery at the same time. Once surgical intervention is necessary, cataract/MIGS should be considered. It's not trabeculectomy," he said. "That's where we need to go. My go-to procedure is cataract/ Trabectome," although he may be in a minority. But for patients with elevated pressure and 20/20 vision (or even those with early disease), the treat- increasing the risk of the procedure and without adverse effects on the visual or refractive outcome," said Thomas W. Samuelson, MD, attending surgeon and a co-founder, Minnesota Eye Consultants, Minne- apolis. Admittedly, MIGS has more modest efficacy than traditional glaucoma surgery. However, combin- ing the best of MIGS with the best of pharma may be a winning combina- tion. "Among the goals of tradition- al glaucoma surgery has been the elimination of medications, but if someone can be managed by using a single drop a day, or (in the future) a single subconjunctival or intraoc- ular injection every 6 months with sustained delivery systems, or a safe, gentle laser procedure, combining such realistic adjuncts with MIGS expands the indications deeper into the severity spectrum." MIGS has established a foothold in the management of glaucoma, "but I don't know that there will be a standalone procedure any time soon as the 'first step' in the management of glaucoma," Dr. Samuelson said, unless the patient is intolerant or incapable of complying with topical medication; "in such cases MIGS as a standalone would make sense if the patient has mild or moderate disease." All three experts agree that newer generations of MIGS are likely to result in regulatory approvals for standalone procedures, once those studies are undertaken. While scientifically many of the devices Should surgeons always combine the two, or can the newer devices stand alone? M icroinvasive glaucoma surgery (MIGS) has revolutionized how surgeons are able to control intraocular pressure (IOP)—and the devices used in these procedures often lend them- selves to an adjunctive procedure if the patient has a visually significant cataract as well. With four potential areas for a MIGS procedure to work (Schlemm's canal, suprachoroidal space, aqueous humor production, and subconjunctival space), and three types of surgical approaches (ab interno, small incision, and conjunctival-sparing), there are significant advantages to using MIGS devices. But are they "good enough" to become standalone pro- cedures? Or will they likely be used in conjunction with cataract surgery for the time being? Or can cataract surgery be enough to adequately control IOP? EyeWorld asked some leading experts to weigh in. "Cataract surgery by itself is still a viable option but is not appropri- ate for every patient," said Brian Francis, MD, associate professor of ophthalmology, Doheny Eye Institute, Geffen School of Medicine, UCLA, Los Angeles. Currently, the "only procedure that falls within Medicare guidelines to get paid as a standalone MIGS procedure is the Trabectome [NeoMedix, Tustin, Calif.]," said Douglas J. Rhee, MD, chair, Depart- ment of Ophthalmology and Visual Sciences, Case Western Reserve University Hospitals Eye Institute, Cleveland. For now, "it will always be cataract and MIGS together, as all the MIGS studies are cataract vs. cataract plus MIGS." The "foundation" and the gene- sis for MIGS is that phacoemulsifica- tion has a favorable effect on IOP for most patients, and surgeons are "go- ing to the operating room anyway for the cataract surgery. With MIGS we add a procedure that's synergistic to the favorable effect of the cata- ract removal without significantly MIGS devices and cataract surgery Device focus The CyPass implanted source: Transcend Medical The iStent Trabecular Micro-Bypass source: Glaukos

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