Eyeworld

EW FEATURE 32 amazement and say, 'No way!' That can't be possible, and yet friends of mine, colleagues whom I completely trust, say they have good results with it. The patients do not get dys- photopsia or unwanted scotomas. It's something I would certainly like to try." The FineVision lens offers pa- tients a full range of multifocality, but does not compromise their inter- mediate vision, said Damien Gatinel, M.D., professor and head, Anterior Segment and Refractive Surgery Department, Rothschild Ophthalmology Foundation, Paris, who helped consult on the design of the lens. Dr. Gatinel said his favorite mul- tifocal 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 ro- tate, 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 post-opera- tively." Besides the Light Adjustable Lens (LAL, Calhoun Vision, Pasadena, Calif.), 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 diffi- cult 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 otherwise, 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 more. The time of surgery is longer. It is not evidence-based that it is better than the current tech- nique. 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. "In- cisions give us a variable effect, de- pending on corneal thickness and level of astigmatism. And they may induce some higher-order aberra- tions 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 it- self," he said. "It gives us the tech- nology 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 compa- nies just have to come to Europe and get much earlier results and updates." Dr. Packer said he looks to Eu- rope for innovative IOL designs. "I don't think it's a particular February 2011 What's ahead in 2012 December 2011 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 innova- tion." 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, M.D., director, Division of Ophthalmic and ENT Devices, Center for Devices and Radiological Health, FDA, Wash- ington, D.C., 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 effec- tiveness, no question that safety is paramount, but these are tested de- signs that have been placed in thou- sands of eyes outside the U.S., and I think it's time that we in this coun- try get a clue," he said. "We all know that after a surgeon gets to his 10 thousandth eye, there may be an un- expected event. There's only risk in approving things to the FDA. 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 de- termined 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: Dr. Mertens has financial interests with Topcon Europe. Drs. Gatinel, Neuhann, and Packer have no financial interests related to this article. Contact information Gatinel: Gatinel@gmail.com Mertens: +32-3-8282949, e.mertens@medipolis.be Neuhann: tneuhann@web.de Packer: 541-687-2110, mpacker@finemd.com Europe's continued from page 31

• Cover