EyeWorld India March 2012 Issue

March 2012 18 EW FEATURE Erik L. Mertens, MD, performs cataract surgery on a patient in Belgium. European clinicians have access to more multifocal IOLs than their American counterparts Source: Erik L. Mertens, MD, FEBO design of the lens. Dr. Gatinel said his favorite multifocal right now is the Acri. LISA diffractive multifocal IOL (Carl Zeiss Meditec), which also has a toric version that he prefers. “The toric doesn’t tend to rotate, and when I have to adjust for placement in the bag, because of its symmetrical shape, I can rotate it clockwise or counterclockwise,” he said. “The lens has a hole close to the edge, which makes a maneuver easy with a hook. I can put the hook in the hole and slightly rotate to the right or left very easily. Lastly, the marks are easy to see at the slit lamp and using aberrometer postoperatively.” Besides the Light Adjustable Lens (LAL, Calhoun Vision, Pasadena, Calif., USA), which technically is a premium but monovision lens, Dr. Neuhann said it’s hard to pick his favorite multifocal. “With all of these lenses we have to meet emmetropia,” he said. “If I am out of range, let’s say 1 D, the whole system doesn’t work, so I have to do a correction after that. It’s difficult to answer because it depends on the anatomy of the patient.” The advent of femtosecond- assisted cataract surgery probably won’t affect the toric market, in Europe or elsewhere, because most surgeons there prefer to use torics over peripheral corneal relaxing incisions, Dr. Neuhann said. “It’s a want-to-have, but not a must-have at the moment,” he said. “I want to have it and see how much I can work with it, but the cost is crazy. The time of surgery is much longer. It is not evidence- based that it is better than the current technique. It’s not cost- effective at the moment.” Dr. Gatinel agreed, and added that PCRIs are not very popular in Europe right now. “Toric IOLs provide reproducible astigmatic correction,” he said. “Incisions give us a variable effect, depending on corneal thickness and level of astigmatism. And they may induce some higher- order aberrations of the cornea later.” Where’s the innovation? Dr. Mertens said he doesn’t look to a particular country or region for the most IOL innovation. “It’s more like the industry itself,” he said. “It gives us the technology to work with, and that is dependent on the companies.” Dr. Neuhann, on the other hand, said that the U.S. is still a big player. “The big ideas are coming from there. The innovative companies are there,” he said. “The big money for investments, to try new things, is coming from the States. These companies just have to come to Europe and get much earlier results and updates.” Dr. Packer said he looks to Europe for innovative IOL designs. “I don’t think it’s a particular country there. Perhaps you could say that the U.K. and Germany have the best optical designs,” he said. “Frankly, I’m embarrassed not to have the latest options. We talk to each other. We know how things are going. I think it’s just gone too far. We’re seeing a hindrance to innovation.” The hindrance? In ophthalmology, the U.S. FDA has a reputation for being too sluggish when it comes to IOL approvals, among others. Malvina B. Eydelman, MD , director, Division of Ophthalmic and ENT Devices, Center for Devices and Radiological Health, FDA, Washington, DC, USA, has called the process “the gold standard” for its focus on safety and effectiveness. “I am aware of many instances where ophthalmic devices have made it to European markets prior to getting to the U.S. market and have been removed due to safety issues while still being investigated in the United States,” Dr. Eydelman told EyeWorld for a November article on innovation. Dr. Packer said the FDA needs to start making some of the tested IOLs available to its citizens. “I’m in favor of safety and effectiveness, no question that safety is paramount, but these are tested designs that have been placed in thousands of eyes outside the U.S., and I think it’s time that we in this country get a clue,” he said. “We all know that after a surgeon gets to his 10 millionth eye, there may be an unexpected event. There’s only risk in approving things to them. There’s a huge incentive to not approve things, and they consistently set the bar higher. I feel setting the bar higher is a good thing in general to encourage better designs and better testing of designs, but for me, the primary mission of the FDA is safety. I think that effectiveness can be determined in the marketplace. If the device is safe, let doctors implant it. If it’s not working out as advertised, people are going to stop using it.” EW Editors’ note: The doctors mentioned have no financial interests related to this article. Cont act info rmation Gatinel: Gatinel@gmail.com Mertens: +32-3-8282949, e.mertens@medipolis.be Neuhann: tneuhann@web.de Packer: 541-687-2110, mpacker@finemd.com International - from page 17