November 2016

 

REFRACTIVE

 

Refractive editor’s corner of the world

SMILE procedure earns FDA approval


by Lauren Lipuma EyeWorld Contributing Writer

 
 

Eric Donnenfeld, MD
T
his has been an incredible year for refractive cornea surgery. First was the approval of the iDesign advanced aberrometer/
wavefront laser from Abbott Medical Optics, which was quickly followed by the Contoura topographic laser from Alcon. Now we have the latest and perhaps the greatest approval: the SMILE procedure using the VisuMax Femtosecond Laser from Carl Zeiss Meditec. The SMILE procedure represents a new category of refractive surgery that singularly employs a femtosecond laser and has gained advocates from around the world for its small incision technology. I agree with Jon Dishler, MD, and Jim Mazzo that SMILE is additive to our refractive surgery armamentarium, and there appears to be good patient acceptance. However, the true judge of any surgical procedure will be safety and efficacy. Right now, the first trial performed in the United States was impressive with 88% of eyes achieving 20/20 or better vision. However, in comparison, the FDA trial for iDesign had 93.4% of patients achieving 20/20 and 79% 20/16. The Contoura FDA trial showed similar results with 92.7% of eyes achieving UCVA of 20/20 and 68.8% reaching 20/16 or better. Our goal as refractive surgeons should be to give patients as good if not better UCVA following refractive surgery as they had with their best pair of glasses preoperatively. We are well on our way.

The initial results of SMILE are exciting, and as with all technology and experience, I expect them to improve over time. There will be challenges including the treatment of hyperopia and enhancements as well as the ability to treat topographic or wavefront abnormalities. However, for now, I could not be more delighted and have the feeling that the FDA gave us an early Christmas present this year.

Eric Donnenfeld, MD, chief medical editor

 
refractive lenticule
A refractive lenticule and small incision of less than 4 mm are created inside the intact cornea in one step.

removal of the lenticule
The lenticule is removed through the small incision with only minimal disruption to the corneal biomechanics.

refractive correction
The removal of the lenticule changes the shape of the cornea, thereby achieving the desired refractive correction.

Source: Carl Zeiss Meditec

Long-awaited procedure expands refractive surgical options for myopes

The U.S. Food and Drug Administration (FDA) approved the small incision lenticule extraction (SMILE) procedure using the VisuMax Femtosecond Laser (Carl Zeiss Meditec, Jena, Germany) for the reduction of myopia in patients 22 years of age or older.

The SMILE procedure is already available in more than 600 clinics in 61 countries worldwide. More than 600,000 SMILE procedures have been performed internationally since its introduction in 2011, according to a press release from Carl Zeiss Meditec. The procedure will be available to U.S. surgeons within the next few months, expanding the refractive options they can offer to patients.

Approval of the procedure is a big win for Carl Zeiss Meditec as a company, for refractive surgeons, and for patients, said James Mazzo, global president, ophthalmic devices, Carl Zeiss Meditec. “I am thrilled that we have this new technology,” Mr. Mazzo said in an interview with EyeWorld. “Any time you get approval of a major product in a major market is a win across any industry.”

Results

The FDA announced approval of the procedure on September 13, slightly sooner than anticipated, Mr. Mazzo said. Results of the clinical study submitted to the FDA showed SMILE patients achieved excellent visual acuity, and refractive results were predictable for the 336 eyes treated at the five investigational sites across the country. Of the 328 participants evaluated at 6 months postop, all but one had uncorrected visual acuity of 20/40 or better, and 88% had uncorrected visual acuity of 20/20 or better.

In addition to the excellent visual outcomes, participating surgeons reported patients experienced a fast visual recovery with minimal discomfort. “I’m excited that it got FDA approval, ahead of when was anticipated, which I think speaks strongly for how strong the results were,” said Jon Dishler, MD, founder of Dishler Laser Institute, Greenwood Village, Colorado. As both investigator and medical monitor in the clinical trial for the SMILE procedure, Dr. Dishler was closely involved with the study from its planning stages through its completion. Approval of the SMILE procedure is a major step forward in refractive surgery—equivalent to the approval of LASIK nearly 20 years ago, Dr. Dishler said. “Over time, [SMILE will] change the landscape of refractive surgery in the U.S., just like it has already in the rest of the world,” he said.

New refractive option

According to Mr. Mazzo, as a next generation procedure, SMILE will invigorate the refractive surgery market in the U.S. “I think we all know the refractive market needs some energy,” he said. “I think this is stimulating that marketplace.” According to Dr. Dishler, patients are captivated by the idea of SMILE, and refractive surgeons are excited about being able to offer it. Without the need to create a flap, there is no algorithm adjustment needed, and the laser calculates just the right amount of tissue needed to be removed, he said. The benefit of this is that the procedure works just as well for patients with high myopia as it does for patients with low myopia, which is not always true of LASIK, he said. The procedure is currently approved to treat between 1 and 8 D of myopia with up to 0.5 D of astigmatism, so it is not yet a solution for patients with significant astigmatism, but can treat virtually all patients with myopia, Dr. Dishler said. Dr. Dishler is currently part of an ongoing clinical study to examine the effectiveness of SMILE in correcting astigmatism, and if the procedure is approved for that use, this will hopefully make it a more comprehensive option for patients, he said. The inclusion and exclusion criteria for SMILE patients are similar to those of LASIK, but the procedure is not great for extremely nervous patients who are prone to squeeze their eyes during surgery, Dr. Dishler said. “There’s a period of about 20 seconds where the lenticule is being cut, and if patients squeeze their eyes, they can interrupt the procedure,” he said. If that happens, the patient loses the ability to continue with SMILE but can go on to another procedure such as PRK or LASIK. SMILE is great for patients for whom having a flap is particularly a problem, such as members of the military and first responders, he said.

In addition, the learning curve for the procedure is relatively fast for experienced refractive surgeons, he said. While Carl Zeiss Meditec will provide training for physicians new to the procedure, Dr. Dishler recommended acquiring the laser and gaining some experience making corneal flaps before moving on to performing SMILE.

Is this the end of LASIK?

While some physicians feel the SMILE procedure threatens the current market of LASIK or PRK, Dr. Dishler disagrees. “I think it enlarges the opportunity and is a complementary innovation to what already exists,” he said. “I think the people who are going to strongly adopt this are those people who wear soft contact lenses, who didn’t feel that LASIK or PRK met their needs. … I think it will increase the number of people who will have refractive surgery, rather than steal patients away from other procedures that already exist at this point.” Mr. Mazzo does not see SMILE as a procedure that will immediately replace LASIK and PRK. “This is not an anti-LASIK procedure—this is a next generation procedure,” he said. “It’s a new option for patients who have questions about the existing options.” SMILE will likely be a premium procedure, at least in the beginning, according to Dr. Dishler. “The pricing of LASIK has been moderated by the competition; if there is a price differential, that will certainly play into people’s decisions about it,” he said. However, he suspects patients will embrace the new refractive option. “I think the public acceptance of this will be pretty strong because it meets what people expect in today’s world from refractive surgery,” he said.

Editors’ note: Mr. Mazzo and Dr. Dishler have financial interests with Carl Zeiss Meditec.

Contact information

Carl Zeiss Meditec
: alice.swinton@zeiss.com
Dishler: jond@dishler.com

SMILE procedure earns FDA approval SMILE procedure earns FDA approval
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