July 2015

 

COVER FEATURE

 

Femto cataract clinical update

Forgoing the femtosecond laser


by Maxine Lipner EyeWorld Senior Contributing Writer

 
   
mild subluxated lens

Manual capsulorhexis in a patient with a mild subluxated lens. While Dr. Hoffman said that the femtosecond laser may be beneficial in cases of rock hard cataracts or subluxated lenses, these are rare in his practice.

Manual capsulorhexis postoperatively

Manual capsulorhexis many years postoperatively Source (all): Richard Hoffman, MD

Why some practitioners are making the choice

While femtosecond cataract surgery has become a hot topic in recent years on the podium, some practitioners continue to perform the traditional phacoemulsification. EyeWorld asked those who have not embraced the new technology about their thinking on this.

David F. Chang, MD, clinical professor of ophthalmology, University of California, San Francisco, thinks that as with any operation, cataract surgeons should be free to individualize their techniques and instrumentation according to their own experience and skill set. Dr. Chang said he is not anti-FLACS, and he welcomes new technologies that may improve patient care. However, what makes femtosecond laser-assisted cataract surgery [FLACS] so different is the high cost that must be borne by the patients, he said. This requires a much higher burden of scientific evidence and justification. Yet most of the largest studies are failing to show benefits that would justify some of the marketing of this technology, he said. Globally, the adoption of FLACS mirrors the degree of economic freedom given to patients by their healthcare system, Dr. Chang said. Some countries allow patients to pay out of pocket for FLACS for any reason. Other countries require patients to opt out of their insurance system to pay privately for a FLACS procedure. In the U.S., however, there are constraints. A key regulatory decision was made by the Centers for Medicare and Medicaid Services (CMS) to permit billing patients only for the refractive benefits of astigmatic keratotomy or for performing the OCT imaging for a premium refractive IOL, Dr. Chang said, adding that CMS could have gone other ways with this. They could have forbidden any patient billing for the femtosecond laser aside from astigmatic keratotomy. This probably would have forced companies to abandon click fees. Alternatively, they could have ruled that robotic technology, like FLACS, is not medically necessary and therefore if patients opt for this, it is up to them to pay for it. This would have created a situation akin to the one that exists in Australia, he said, where patients are completely free to pay the additional FLACS costs for any reason. As it stands in the United States, we are not allowed to bill patients for the cataract surgical steps performed with the femtosecond laser, Dr. Chang said. I regret that American seniors who dont mind wearing glasses dont have the right to pay their own money for FLACS if they want it. Currently, however, he is also not convinced of the additional refractive benefits of using the femto laser. We never purchased a femtosecond laser because I dont believe there to be a refractive benefit to my own patients, he said, adding that he prefers to use a toric IOL rather than femtosecond laser astigmatic keratotomy for those patients who want and can afford astigmatism correction. Richard R. Schulze Jr., MD, Savannah, Ga., believes that he has an ethical obligation to put his patients financial well being ahead of his own. If I can be convinced that femtosecond lasers are better for my patients, I will use them, he said. As it stands, however, when performed by a skilled surgeon, femtosecond laser-assisted cataract surgery offers no significant benefit to the patient, he said, adding that if this hypothesis can be disproven, all practitioners should move to femtosecond laser-assisted cataract surgery.

While there have been many claims by the femtosecond industry of lower ultrasound times, better incisions, and safer procedures, the actual benefits of incorporating the technology remain in dispute, Dr. Schulze said. Although claims of lower ultrasound usage in conjunction with FLACS are true, if the laser is used for corneal incisions, there is increased cell loss from these, which may offset any beneficial effect of lower ultrasound time, he pointed out, adding that at the 6-month mark there is no difference in endothelial cell density between the procedures.

Use of the femtosecond laser for cataract surgery has also not proven to be safer, Dr. Schulze said. He cited the ESCRS study on FLACS reported by Peter Barry, MD, in September 2014, which indicated that the femtosecond complication rate was 3.2% versus 1.8% for traditional phacoemulsification. Given all, he finds the upcharge for the patient troubling. Dr. Schulze offered a quote from another practitioner who ultimately returned his femtosecond laser to the manufacturer: I couldnt look a patient in the eye and ask him to spend an extra thousand dollars for a technology that wouldnt make his outcome any better. That practitioner, he said, was from a large practice where they could buy such technology without any significant financial implications. However, for those even in medium-sized practices, once they have purchased the laser, they are on the hook financially and have to up-sell it to their patients in order to make payments, he said. This can put them on an ethically slippery slope because there is no benefit for routine cases or even for more complicated cases involving small pupils, weak zonules, or shallow chambers, he said.

Richard Hoffman, MD, clinical associate professor of ophthalmology, Oregon Health & Science University, Portland, Ore., remains unconvinced about the benefits of using the femtosecond laser for cataract surgery. He is concerned about making the economic factors work. Im in an environment where I have trouble convincing my patients to pay $400 or $500 for limbal relaxing incisions to address their astigmatism, which is something that adds definite value, he said. Just taking out the cataract with the femtosecond laser doesnt give improved outcomes, in my view. While the laser can be used to address the patients astigmatism, Dr. Hoffman sees this as much more expensive than simply putting in a toric implant or performing a manual limbal relaxing incision.

In routine cases removing the cataract with traditional methods appears to Dr. Hoffman to be just as good as with the femtosecond laser. While he acknowledged that there is likely a benefit in cases of rock hard cataracts or subluxated lenses, these are rare in his practice. In addition, use of the femtosecond laser for cataract surgery tends to be less efficient, he said. It slows down the procedure by 5 or 10 minutes, Dr. Hoffman said, adding that he has heard stories of some practitioners abandoning the use of the femtosecond laser, citing decreased efficiency. Also, the economics can be problematic. It adds $350 to each procedure that you have to pass on to your patient unless you want to absorb that. Thats just for the disposables, not even for the cost of the laser or the maintenance of the laser. He acknowledged, however, that the femtosecond companies are attempting to address this by making leasing programs available. There are some companies that are bringing them on as roll-on, roll-off, which is nice because the surgeon doesnt have to put out any economic outlay, Dr. Hoffman said, adding that they can just use this for the day. There are also programs available where if you have a minimum number of cases you can keep the laser for 1 year. Despite such options, he has continued to put off incorporating the femtosecond laser into his practice because he sees no pressing need. He thinks that a lot of other surgeons out there are hoping that the technology goes away so that they dont have to deal with it. All of the claims that were made initially on this havent panned out, Dr. Hoffman said. If it was revolutionary, there wouldnt be any hesitation. In order to embrace the femtosecond technology, it would have to become more efficient and cost less, he noted. Dr. Chang likewise hasnt seen any convincing benefits that would warrant the additional out of pocket costs for his patients. I utilize ORA [Alcon, Fort Worth, Texas] and Callisto [Carl Zeiss Meditec, Jena, Germany], but dont believe that FLACS would provide any further refractive benefits in my hands, Dr. Chang said. In his view, declarations that the femtosecond laser will be the future of cataract surgery remain premature, especially with other new technology now in the wings. Mynosys [Freemont, Calif.] has developed Zepto, a disposable intraocular nano-pulse handpiece and tip that may be able to automate creation of a perfectly circular capsulotomy, he said. There is also a handheld thermal laser [CAPSULaser, Los Gatos, Calif.] being developed that can be manually inserted into the eye for this step. He pointed out that the Light Adjustable Lens (Calhoun Vision, Pasadena, Calif.) has completed FDA phase 3 trial enrollment. If this becomes available, it could dramatically alter the willingness to recommend that patients pay for FLACS as a means to improve refractive outcomes, Dr. Chang said. Still, there are some economic changes that might ultimately make the technology more appealing, he thinks. Abandoning click fees would change the paradigm for everyone, he said, adding that higher volume facilities could amortize the capital costs over many cases. Removing cost and refractive indications from the decision would expand access of this technology to more patients, he believes. However, I dont see this happening because weve learned that many patients are willing to pay out of pocket for technology that their surgeon recommends, Dr. Chang concluded.

Editors note: Drs. Hoffman and Schulze have no financial interests related to their comments. Dr. Chang has financial interests with LENSAR (Orlando, Fla.), Calhoun Vision, PowerVision (Belmont, Calif.), Clarity Medical Systems (Pleasanton, Calif.), and Mynosys.

Contact information

Chang
: dceye@earthlink.net
Hoffman: rshoffman@finemd.com
Schulze: richardschulze@comcast.net

Forgoing the femtosecond laser Forgoing the femtosecond laser
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