EyeWorld India June 2017 Issue
14 EWAP FEATURE June 2017 word out that patients should come in and talk to their doctor if they’re having these issues.” Even if the patient comes in the door and is not a candidate for an inlay, Dr. Durrie said he or she might be a candidate for another procedure to improve vision. “These people are coming in for the inlay, but some are not great candidates. Still, you can talk to them about what they are a great candidate for. That’s why we’ve seen this real interest in practice growth,” Dr. Durrie said. EWAP References 1. Barraquer JI. Queratoplastia Refractiva. Estudios e Informaciones Oftalmológicas . 1949;10:2–21. 2. Barraquer JI. Modification of refraction by means of intracorneal inclusions. Int Ophthalmol Clin . 1966;6:53–78. 3. Steinert RF, et al. Hydrogel intracorneal lenses in aphakic eyes. Arch Ophthalmol . 1996;114:135–41. 4. AcuFocus. Ophthalmic Devices Panel Executive Summary. FDA. 2014. Accessed Jan. 9, 2017. www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeeting Materials/MedicalDevices/Medical DevicesAdvisoryCommittee/Ophthalmic DevicesPanel/UCM399644.pdf 5. ReVision Optics. Summary of Safety and Effectiveness Data. FDA. 2016. Accessed Jan. 9, 2017. www.accessdata.fda.gov/ cdrh_docs/pdf15/P150034b.pdf Editors’ note: Dr. Lindstrom has financial interests with AcuFocus. Dr. Durrie has financial interests with AcuFocus, Alcon (Fort Worth, Texas), and Abbott Medical Optics (Abbott Park, Illinois). Drs. Chu and Whitman have financial interests with ReVision Optics. Dr. Manche has no financial interests related to his comments. Contact information Chu: yrchu@chuvision.com Durrie: ddurrie@durrievision.com Lindstrom: rllindstrom@mneye.com Manche: edward.manche@stanford.edu Whitman: whitman@keywhitman.com patients’ experience with the inlay has been good, he noted a monovision contact lens trial helps determine the best power and patient tolerance. According to a Presbia press announcement from May 2016, all 412 study participants in the pivotal study had completed 6-month postop visits. The company said that by the fourth quarter of 2017, it expects to have 24-month postop data on 300 patients to submit its premarket approval module to the FDA. In August 2016, Presbia acquired Neoptics (Hünenberg, Switzerland), integrating intellectual property and know- how from the latter company’s Icolens—a bifocal, hydrogel (2-hydroxyethyl methacrylate and methyl methacrylate) implant— into the Flexivue Microlens. What inlays bring to the market “Everybody gets presbyopia and nobody loves presbyopia,” Dr. Whitman said. “Here’s a disease that affects everyone, so there is a huge market out there in a patient segment that should be able to afford it.” Until the recent approval of intracorneal inlays, the only surgical option for presbyopia was monovision or multifocal IOLs at the time of cataract surgery. These implants offer freedom from readers (though there will be situations where they may still be needed) without compromising distance vision and without having to wait for a cataract to develop. What’s more, they can be removed if the outcome is not positive. With two FDA-approved inlays on the market and a third expected, ophthalmologists differ in their opinions as to how they’ll be adopted. Some think physicians will train in all inlay types, giving them the ability to choose the best inlay for each patient’s situation. Others, however, think surgeons will choose to specialize in one and will use PRK or LASIK to tailor the patient to the inlay. Dr. Lindstrom said while it might start with physicians choosing to work with a specific inlay, he thinks surgeons will eventually add more options. “It’s a bit like if you look at presbyopia-correcting lenses,” Dr. Lindstrom said, noting that ophthalmologists use different types of multifocal IOLs depending on the patient. “I think this will be the same. … My group has decided, based on current volume of procedures and experience we have, that we’re going to continue doing the KAMRA for now, but that doesn’t mean we would never want to get trained in the Raindrop or Flexivue in the future. “The bottom line is it’s too soon to know how this is going to sort out. The good news is we have two good choices of something we never had before and within a year or two we’ll have a third good choice,” Dr. Lindstrom said. Invigorating ophthalmology While the inlays are beginning to serve a previously untapped market, they’re also reinvigorating ophthalmologists and their practices. “Inlays not only are great new technologies, but I think they’re firing up surgeons again to start thinking about how they can take care of these patients,” Dr. Durrie said. “Sometimes practices need a new technology, like an inlay, to get them fired up to start doing promotions, seminars, Facebook Live, and other things to get the History – from page 13
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