EyeWorld Asia-Pacific June 2012 Issue

June 2012 26 EWAP CATARACT/IOL requires recharging every 3-4 days. The company is conducting demographic studies with select patient populations to create an ideal, noninvasive charging process. The most promising idea is to charge the IOL while the patient sleeps, building a system into a pillow or an eye mask. As anyone with a computer knows, though, electronics fail. Batteries can clunk out. So what happens to the IOL and, more importantly, the patient’s vision, if something goes awry? “The fail-safe system is the IOL falling back to having only optimal distance vision … defaulting to a monofocal IOL,” Dr. Maxwell said. “The patient goes back to needing reading glasses.” ELENZA also has a back- up plan for the absentminded patient who may forget the charger while on an extended vacation: a hibernation mode. If not recharged, the IOL defaults to a monofocal lens and can be rebooted up to 9 months later. Furthermore, the lens is fully programmable and customizable, allowing the physician to remotely adjust the sensitivity and magnitude of the switching point of the add power in the IOL by up to three-quarters of a diopter, based on the particular needs of the patient. “This is the most sophisticated computer chip and algorithm ever used in an implantable medical device,” Mr. Mazzocchi said. “Within the first 300 seconds, this IOL is going to learn the specific pupil dynamics of that patient and customize its own internal algorithm. As the patient’s needs change with time, the physician during a visit can reboot that algorithm and alter its program remotely and noninvasively. It’s a patient-specific, adaptive, programmable IOL.” Lingering questions Even with all of ELENZA’s promises, there are remaining safety and technological issues the company must overcome before the lens is ready for prime time. For example, what happens to the electronic components if the lens is hit with a YAG laser? Are any of the materials toxic? What if there’s leakage? “These sapphire-coated batteries are sealed and encased in 24-carat gold,” Mr. Mazzocchi said. “We’ve tested and proven the integrity of this casing and sealed the battery and all the electronics in a thin glass wafer that’s hermetically sealed and then encapsulated into a conventional monofocal IOL.” “At this point, knowing what the chemists and engineers know about the [lens] material, we don’t think [toxicity] will be a problem, but you never know until you test it,” Dr. Maxwell said. Another concern is how to implant the lens through a conventional small incision without inducing astigmatism. “We have a lens design that will fold and still maintain the integrity of all the internal electronic components,” Dr. Maxwell said. “We also have designed an injecting system that the IOL will fit into so it will go into the small incision without any trauma.” Look for it in 2014, 2018 ELENZA is taking all of 2012 to knock out these concerns and others one by one and is not far from developing a finished, clinical-grade product. The hope is for in-man studies beginning in Europe early in 2013. “ELENZA expects to obtain a CE mark in early 2014,” Dr. Lindstrom said. “FDA approval could take 4-5 years after the first implant in man,” he said, “bringing the lens to U.S. soil around 2018.” “ELENZA is a very exciting project for me right now,” Dr. Lindstrom said. “While there are always surprises along the way, we are pretty confident we can make this work.” Although the IOL is years from U.S. commercialization, Mr. Mazzocchi and Dr. Maxwell don’t believe physicians and patients will be skittish about implanting a computer chip and battery in the eye. “My philosophy is pretty simple,” said Mr. Mazzocchi. “As long as this lens feels and looks like a conventional IOL and you can use the same insertion procedure, we anticipate no major adoption issue.” “There will be a group that will want the new technology immediately and a group that will be more conservative,” Dr. Maxwell said. “Ophthalmology, in general, has been a specialty that’s embraced new and advanced technology, especially with achieving our Holy Grail without any particular complications. We’ve learned to be more accepting of advanced technology.” EWAP Editors’ note: Drs. Lindstrom and Maxwell are medical consultants for ELENZA. Mr. Mazzocchi has financial interests with ELENZA. Contact information Lindstrom: rllindstrom@mneye.com Maxwell: amaxwellmd@gmail.com Mazzocchi: rudy@elenza.com Electronic - from page 25 Getting - from page 24 higher-order aberrations in a sub- study of the FDA trial, they found a jump in these after implantation of the Tetraflex. “There was a 34% increase in total higher- order aberrations compared to a monofocal control,” Dr. Dougherty said. An FDA study comparing reading speed with the Tetraflex to the Crystalens (Bausch + Lomb, Rochester, NY, USA) showed statistically significant improvement for patients with the Tetraflex. “I think that it offers better near vision,” Dr. Dougherty said. Another feature that is unique about the Tetraflex is that it is very tightly titrated. “It’s manufactured to 1/8 of a diopter tolerance, whereas ANSI [American National Standards Institute] standards allow up to 1 D of variation depending on lens power,” Dr. Dougherty said. With the lens the majority of patients enjoy good social reading. “In the FDA study binocular accommodative amplitude at 1 year showed that 9% of patients had 1 D or more of accommodation, and 68% had 2 D or more of accommodation,” Dr. Dougherty said. He estimated that about 75% of patients never or only occasionally need reading glasses. The FDA trials in the U.S. have been completed, and the Tetraflex has received CE mark approval. “I can’t wait for it to be FDA approved so that I can offer it to my patients,” Dr. Dougherty said. EWAP Editors’ note: Dr. Dougherty has financial interests with Lenstec. Dr. Koch is on the advisory board of NuLens, but he has no financial interests related to this article. Dr. Nichamin has financial interests with PowerVision. Dr. Packer has financial interests with AMO. Dr. Slade has financial interests with NuLens. Contact information Dougherty: flapzap@gmail.com Koch: +1-713-798-6443, dkoch@bcm.edu Nichamin: +1-814-849-8344, nichamin@laureleye.com Packer: +1-541-687-2110, mpacker@finemd.com Slade: +1-713-626-5544, sgs@visiontexas.com