EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/78719
February 2012 IOLs February 2011 EW FEATURE 59 Lingering questions Even with all of ELENZA's promises, there are remaining safety and tech- nological issues the company must overcome before the lens is ready for prime time. For example, what hap- pens 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 conven- tional 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 im- plant the lens through a conven- tional small incision without inducing astigmatism. "We have a lens design that will fold and still maintain the integrity of all the internal electronic compo- nents," 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 2018 ELENZA is taking all of 2012 to knock out these concerns and others one-by-one and is not far from de- veloping 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. Lind- strom 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 al- ways 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 com- puter chip and battery in the eye. "My philosophy is pretty sim- ple," said Mr. Mazzocchi. "As long as this lens feels and looks like a con- ventional IOL and you can use the same insertion procedure, we antici- pate no major adoption issue." "There will be a group that will want the new technology immedi- ately 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 with- continued on page 60 An ASCRS Membership For every stage of your career Whether you're just beginning or experienced in cataract and refractive surgery, ASCRS is the professional society that's right for every stage of your career. Young Ophthalmologists & Residents When you're the newest member of the team, things can be a little overwhelming. ASCRS can help with the transition. Our monthly Journal of Cataract and Refractive Surgery, Annual Symposium, and online educational initiatives work to continuously augment your formal training. Through them you'll meet like-minded young ophthalmologists facing similar challenges and concerns, along with those who've successfully navigated the waters and can provide the guidance to answer your clinical, financial, and practice management questions. For young practitioners, ASCRS is where the anterior segment ophthalmology community comes together. ASCRS offers U.S. residents and fellows an unmatched opportunity to experience anterior segment ophthalmology beyond your training program—all at no cost! Resident and fellow membership, which includes the Annual Symposium, is free during your training. ASCRS makes it easy to gain real-world experience and education with no added cost. Join ASCRS today! The Society for Surgeons AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY 4000 Legato Road, Suite 700, Fairfax, VA 22033 • 703-591-2220 • www.ASCRS.org