EyeWorld Asia-Pacific June 2016 Issue

June 2016 14 EWAP FEATURE a small, but profitable market, allows the technology to survive, improve, and advance. Eventually the cost declines and the entire population gains access to better and more affordable versions of the technology (e.g. cell phones, computers). Socialized healthcare systems deprive many expensive new technologies of a viable market; this stifles innovation and ultimately deprives society of any consequent rewards. For these reasons, I regret that we could not collaborate with industry to create a robotic category of non- covered (not medically necessary) services that—such as cosmetic and refractive services—would be available only to patients electing to pay the costs themselves. Instead, in the land of capitalism and free markets, American seniors who don’t mind wearing glasses don’t have the right to pay their own money for FLACS if they want it. Evidence lacking to justify higher FLACS cost Although surgeons typically base instrument preferences on personal anecdotal experience, recommending that patients pay the high cost of FLACS requires a greater burden of scientific evidence and justification. Because conventional cataract surgery has such excellent outcomes, properly analyzing the benefit of FLACS requires very large clinical studies. The FEMCAT study is a prospective, randomized, controlled clinical trial funded by the French government, in which sham docking will mask patients from knowing whether they were treated with the laser or not. Selection bias is further reduced by virtue of no patient having to pay extra for FLACS. This trial has not completed enrollment but the forthcoming results should be the most credible to date. The largest retrospective study is the ESCRS-sponsored EUREQUO trial, which compared approximately 2,800 consecutive FLACS eyes from 16 selected centers to 5,000 matched phaco eyes entered into the ESCRS cataract registry. There was no industry sponsorship and no reporting bias, because the results were going to be presented regardless of the findings. A weakness of any registry-based study is the lack of prospective randomization. Because of this, the investigators made a diligent effort to match the two study populations—including age, preoperative acuity, and co-morbidities. It was certainly notable that the FLACS patient population had statistically higher postoperative complication rates. A retrospective study such as this doesn’t prove that FLACS is inferior or more risky than phaco. However, the EUREQUO study provides some of the strongest evidence to date that broad claims of FLACS superiority are misleading and wrong. It is also noteworthy that the FLACS surgeons in the EUREQUO study are all top cataract surgeons within their respective countries—a European femto surgeon “all-star” team. I would have expected this elite group of surgeons to have superior collective outcomes when compared to the broad universe of community ophthalmologists from the registry. I was impressed that even when armed with this cutting edge technology, the top femto surgeons in Europe and Australia did no better—and by some parameters worse—than the registry surgeons using manual phaco. To me, this was a striking finding. Why I don’t perform FLACS We never purchased a femtosecond laser because we wanted to first be convinced that the benefits would justify the operating room inefficiency and the substantial costs that would need to be passed on to our patients. I utilize ORA (Alcon, Fort Worth, Texas) for refractive cataract cases, which includes toric and multifocal IOLs, LRIs, and post-LASIK eyes. I use the Zeiss Callisto system (Jena, Germany) to digitally mark the astigmatic axis intraoperatively. Although they add some expense, these two complementary technologies improve my refractive outcomes for these cases. However, I cannot justify using and charging my patients for the femtosecond laser as a means of further improving refractive outcomes, as allowed in the U.S. I prefer to use a toric IOL rather than laser astigmatic keratotomy for those patients who want and can afford the most predictable astigmatism correction. I understand the preferences of some surgeons to use FLACS for certain complicated eyes, such as white cataracts. However, these cases are uncommon and in the U.S. and we are not allowed to pass the fees on to our patients for these indications. In addition, the infrequency of these cases would not justify the significant cost and workflow inefficiency of having and maintaining a laser. Abandoning the FLACS click fee could change the paradigm for everyone. Removing cost and refractive indications from the decision would expand access of this technology to more patients. Higher volume facilities could amortize the capital costs over many more cases. However, I doubt that this will happen because we’ve seen in the U.S. that many patients are willing to pay out-of-pocket for technology that their surgeon recommends. Pronouncements that FLACS will be the future of cataract surgery remain premature in my opinion. Mynosys (Fremont, Calif.) has developed Zepto—a disposable intraocular instrument that automates creation of a perfectly circular capsulotomy [See “New technology for capsulotomy” in this issue – Ed.]. CAPSULaser (Los Gatos, Calif.) is another approach—a microscope-mounted thermal laser that automatically creates the capsulotomy in the normal surgical sequence. Finally, when the Calhoun light adjustable IOL (Pasadena, Calif.) becomes available it will become more difficult to recommend FLACS to American patients as way to improve their refractive outcome. EWAP Editors’ note: Dr. Chang is clinical professor at the University of California, San Francisco. He was the medical monitor and a consultant for LensAR. He currently consults for Calhoun Vision, PowerVision, Clarity, and Mynosys. He has no financial interest in Alcon, Wavetec, or Zeiss. Why I don’t - from page 13