Eyeworld Daily News

EW SHOW DAILY 38 ASCRS Symposia Monday, May 9, 2016 by Chiles Aedam R. Samaniego EyeWorld Asia-Pacific Senior Staff Writer Bringing LASIK back S omeone once said: "To- morrow belongs to those who can hear it coming." Refractive surgeons who want to keep their practice ahead of the curve have their ear almost constantly to the ground, always on the lookout for the next big thing in terms of techniques and technology to achieve the best out- comes for their patients. That said, a perfectly good technology isn't typically left by the wayside unless it is rendered obsolete by something better. So what happened with LASIK? In a symposium on "Bringing Back LASIK," Richard Lindstrom, MD, Minneapolis, took a closer look at the state of the industry Where are we now? Dr. Lindstrom has been through the entire history of LASIK to date, and has seen the rise and fall of the pro- cedure. He first used excimer lasers in 1988, and was there for the first FDA approval for a LASIK device in 1996. Immediately after its introduc- tion into the U.S. market, LASIK saw rapid growth, with the number of procedures per year doubling each year from 1996 to 2000. The market for LASIK hit its peak in 2001, and leveled out from 2001 to 2007. The decline began in 2008, as the U.S. economy entered the great recession. Since then the economy has recovered, but while LASIK rates have more or less leveled out, they remain far reduced from the proce- dure's heyday. Fortunately for industry, LASIK exists outside the U.S. as well, and while the market outside the U.S. from 2008 to 2015 has varied from stable to declining overall, growth is still being seen in countries such as China, India, and other emerging markets. But what happened to the re- fractive market in the U.S. and why has it not recovered? Dr. Lindstrom considered a number of possibilities: Have all the good candidates for LASIK been treated? Did LASIK, after all, achieve poor results or cause prohibitive complications? Have marketing and advertising been lacking? Is the in- terest of doctors in the procedure de- clining? Has there been an improve- ment in alternative technologies? Or is it simply a change in priorities for LASIK candidates? Considering these questions, Dr. Lindstrom concluded that the refrac- tive surgery market has stabilized at a new base, and the softness in the demand is not economic. The pool of available patients is growing, but cultural and generational issues may prove to be major constraints going forward. Bringing back LASIK, he said, requires more marketing focus on generation X and generation Y. Manufacturers, laser centers, and doctors need to get interested, and focus on the advantages of LASIK over alternative procedures. Waiting in the wings LASIK is far from obsolete. In fact, the 1 word Steven Dell, MD, Austin, Texas, said he would use to describe the refractive results of LASIK using current technology is "superb." He said that while a small fraction of patients will experience dissatisfac- tion with LASIK owing to dyspho- topsia or dry eye symptoms, these symptoms at 6 months postop are actually less prevalent than preop. Nonetheless, next generation re- fractive surgery technologies are al- ready waiting in the wings. Perhaps the truest innovation is the small incision lenticule extraction (SMILE) procedure, in which a femtosecond laser is used to carve a refractive lenticule out of the corneal stro- ma. The lenticule is then extracted through a small incision to alter the shape of the cornea. SMILE is investigational and not yet approved for use in the U.S., but John Vukich, MD, Madison, Wis- consin is 1 of the investigators. From their results so far, Dr. Vukich said that 99.7% of eyes undergoing SMILE had UCVA 20/40 or better at the point of stability; 87.5% of eyes had UCVA of 20/20 or better by 6 months and 88.1% by 12 months; 98.5% of eyes had MRSE within ±1.00 D, 93% had MRSA within ±0.50 D, and 79.6% of eyes had MRSE within ±0.25 D at point of stability; and MRSA stability was achieved at the 3- to 6-month interval and confirmed at the 6- to 9-month interval. The procedure, Dr. Vukich said, has been available outside the U.S. since 2011. The U.S. investigational device exemption was approved in April 2012, premarket approval submitted on October 29, 2015, and the target date for the panel meeting is sometime in late 2016 or early 2017. EW Editors' note: Dr. Lindstrom has financial interests with Abbott Medical Optics (Abbott Park, Illinois), Alcon (Fort Worth, Texas), Bausch + Lomb (Bridgewater, New Jersey), and various companies engaged in manufacturing products for refractive surgery. Dr. Dell has financial interests with Abbott Medical Optics and Bausch + Lomb. Dr. Vukich has financial interests with Abbott Medical Optics and Carl Zeiss Meditec (Jena, Germany). Refractive results of LASIK using current technology, says Dr. Dell, are "superb." Dr. Lindstrom reviews the rise and fall of LASIK.

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