Eyeworld

EW FEATURE 108 Controversies in cataract surgery • April 2017 AT A GLANCE • There are several companies around the world producing artificial iris devices, but none of these devices are currently approved in the U.S. One device is in an FDA trial. • Creating this artificial iris involves taking an index photo of the unaffected eye and then making a custom device for each patient. • When deciding when it may become necessary to use this type of device, it's important to look at how much of the patient's existing iris remains. by Ellen Stodola EyeWorld Senior Staff Writer Another valuable component is to start thinking about the device whenever doctors see a patient who has some sort of iris affliction, Dr. Snyder said. It's important to reflect on who may benefit from this tech- nology. There are some patients, Dr. Snyder said, for whom you might be able to use stitches or stretch the iris tissue to create adequate aperture. But sometimes, when a lot of those maneuvers are required, a patient could be better served with an iris device placed in the capsular bag during cataract surgery. That could be quicker, safer, less risky, and with a better cosmetic result, he said. Dr. Snyder said that he expects that if and when the device is ap- proved by the FDA, there will likely be certain indications for on-label use. As physicians, there is an ob- ligation to patients to determine if that device is going to be useful to them. He noted that the FDA label- ing will likely also depend on which patients with certain conditions may have been included in study data. Certain situations may arise that were not represented in study data, he added. Typically the decision-mak- ing for when to use the device is based on how much of the patient's existing iris remains, whether it would mend itself based on the amount that remains, and wheth- er the strength of iris tissue would hold sutures, Dr. Masket said. The said. The device is created based on an index photo. "Whenever we use the devices, we have to obtain a high-quality color photograph from the unaffected eye from which the device is made." Basically, you take a picture of the unaffected eye, and the manufacturer then crafts it to make as close a match as possible to the index photo, though Dr. Snyder noted that when looking through the slit lamp, you can sometimes notice slight differences. Not only is each custom colored, but the surface of the device is molded to have a texture similar to anterior iris, he added. These artificial iris devices perform very well in reducing light sensitivity, contrast sensitivity, glare, and halos, he said. Another important factor for surgeons to prepare for is the technical aspect of how to insert the device. There is a learning curve because these are maneuvers that are not common in normal daily activity, Dr. Snyder said. The ASCRS has established an artificial iris wet- lab that has been run at the annual meeting in the past and will be on the program again this year, he said. This allows physicians to use all of the devices to get a better under- standing of them. This is "probably the best way at this moment to become comfortable with implanta- tion technique," he said. practice is one of those sites, and the others are dispersed around the country. Dr. Masket said that he has seen patients from the West Coast, the central part of the country, and outside the US. One stipulation in the inves- tigation is that postoperative visits also need to be at the study center, Dr. Masket said. This includes a follow-up appointment at 1 day, 1 week, 1 month, and at 3, 6, and 12 months. It's quite remarkable, he said, how compliant patients have been with these follow-up appoint- ments. The patients seem to recog- nize the significance of the investi- gation. "It really is a transformative experience when the defective iris is replaced," he said. The original cohort of the study was 180 eyes, Dr. Masket said. That was filled, but the FDA has allowed continuing access, he said, making it possible for sites to continue to enroll patients. Surgeon preparation for device approval There are a number of ways sur- geons can prepare for approval of this artificial iris device. When you talk about adding new technology to your armamentarium, Dr. Snyder said, you have to consider how to obtain the device and how to tech- nically put it in. Procuring the device involves a number of specific logistics, he Physicians discuss artificial iris devices and their use C urrently in the United States, there are no Food and Drug Administration (FDA)-approved artificial iris devices. However, one of these devices is part of a clinical trial in several locations around the country. Michael Snyder, MD, Cincinnati Eye Institute, Cincinnati, and Samuel Masket, MD, Advanced Vision Care, Los Angeles, discussed artificial iris implantation, the status of these devices, and their own ex- periences using them in the clinical trial. Currently, there are four man- ufacturers of artificial iris devices globally: Morcher (Stuttgart, Ger- many), Ophtec (Groningen, Neth- erlands), HumanOptics (Erlangen, Germany), and Reper (Nizhny Novgorod, Russia). The HumanOp- tics device is currently undergoing FDA trial, Dr. Snyder said. Though the PMA arm of the study has been fully recruited, Dr. Snyder said that physicians partic- ipating in the trial are still able to continue enrolling patients through a continuing access arm. "It is our hope that the device will become available through the FDA process on a more widespread basis," he said. Currently, the only option for an ophthalmologist with a patient who needs artificial iris implanta- tion is to refer the patient to one of the FDA-approved sites in the investigation, Dr. Masket said. His Status of artificial iris implantation devices in the U.S. An example of the HumanOptics silicone custom artificial iris Source: Samuel Masket, MD

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