Refractive
Summer 2025
by Ellen Stodola
Editorial Co-Director
When it comes to refractive procedures, there are many options available. Several physicians discussed what they’re using and the options available, notably market penetration of the Implantable Collamer Lens (ICL, STAAR Surgical) and SMILE in different areas and how this has changed over the years. They also discussed how other procedures, particularly LASIK, still fit in as newer options become popular.
Source: STAAR Surgical
Yoshihiro Kitazawa, MD
Dr. Kitazawa shared his experiences in Japan. He noted that the ICL had the highest number of cases in all refractive surgeries in 2023 in the country, performed in 70% of cases, followed by LASIK. In 2024, Zeiss SMILE pro on the Zeiss VisuMax 800 received regulatory approval in Japan, which may drive broader adoption of SMILE.
Dr. Kitazawa said that LASIK is the most performed refractive surgery not only in the U.S. but also outside the U.S. However, in Korea, the most common refractive surgery is SMILE.
“In Japan, LASIK has been declining for the past 10 years due to infection cases, price reduction competition by ophthalmology clinics owned by cosmetic surgery clinics, and negative campaigns,” Dr. Kitazawa said. “Many Japanese ophthalmologists have a bad image of LASIK as a commercial venture by cosmetic surgeons. The ICL is rapidly increasing in popularity.”
Dr. Kitazawa thinks patient comfort and education play a role in which procedures are used more often. Patients are becoming more informed on the technologies. Many who have researched refractive surgery think the ICL is safe and reliable, he said.
Dr. Kitazawa said the updated EVO ICL has also helped with the surgery gaining popularity. The EVO ICL is FDA approved to treat myopia ranging from –3 to –20 D and up to 4 D of astigmatism. The development of the EVO ICL with a central hole has contributed to the widespread use by reducing postoperative complications such as cataracts and glaucoma, he said.
ICL surgery can be performed by any cataract surgeon with a phaco machine. In Japan, an increasing number of doctors have given up LASIK because of the difficulty of maintaining expensive excimer lasers, and the number of new laser purchasers is almost zero.
Source: Zeiss
Boris Malyugin, MD, PhD
Dr. Malyugin spoke about his knowledge of refractive procedures in several countries, notably Russia and China.
He said that ICL surgery is a big business in China. They are implanting ICLs in numbers exceeding any other country in the world, not only because it’s a vast country but also due to the population’s predisposition to develop myopia at a young age. Myopia is a growing problem in the Asia-Pacific region, he said.
New technology, like the EVO ICL, has helped the growth of this as well because surgeons are more confident with an easier and safer procedure and not having to create an iridotomy, he said.
In Russia, the market penetration of ICLs is minimal. There are alternatives to ICLs from several local manufacturers. In China, some companies are now starting to produce phakic lenses as well, inspired by the ICL market success. Most of the novel phakic IOLs are made of hydrophobic acrylic materials, he said, noting that these do not have quite the same great track record as the ICL yet.
Concerning SMILE and intrastromal lenticular procedures, Dr. Malyugin said these procedures are not yet widely adopted in Russia, in his experience. “Femto LASIK is still the procedure of choice for most of the surgeons,” he said, adding that one reason for this could be that the difference in visual outcomes is not dramatically different between femto LASIK and SMILE. “Surgeons like SMILE because they think that it’s less invasive with less induced dry eye and potentially affects corneal biomechanics less.”
In Russia and China, companies and clinics are advertising quite heavily. “They want to distinguish themselves, and utilizing these lenticular procedures is an opportunity to gain attention and promote the latest, cutting-edge technologies.”
The penetration of lenticular procedures in Russia is around 20%, while in China, in many clinics it’s more than 80%. Dr. Malyugin noted that he has heard from Chinese colleagues that they started with the SMILE procedure, while many of his Russian colleagues started with femto LASIK.
“With respect to training and education, those doctors doing femto LASIK for many years are hesitant to change,” he said. “But younger doctors are more open to new techniques and might be starting with SMILE or CLEAR [Ziemer]. They are more open to these lenticular-based procedures than those who haven’t been doing them from the beginning.” He added that education is important because surgeons will naturally offer the procedure that they are most comfortable with.
Premium lenses are strong competitors to laser procedures in presbyopic age, he added, and more and more surgeons are suggesting patients go with refractive lens exchange rather than laser.
In the U.S., Dr. Malyugin has noticed that laser refractive procedures are not on the rise, however, many surgeons are interested in the ICL and said he’s seen a growing interest among younger doctors in learning the technology. Although he did note that it is quite expensive, and that might be a steep barrier for patients. “I think it’s a still-growing market,” he said.
Robert T. Lin, MD
Dr. Lin practices in California and is well versed in using SMILE and the ICL, as well as other refractive procedures.
With SMILE, there’s less corneal nerve injury because the opening is very small, he said. “With less corneal nerve disruption, we have noticed less dry eye symptoms during the first 6 months than with LASIK. That’s the main reason I moved to doing SMILE for the majority of my patients.”
Dr. Lin noted that SMILE has other advantages because it has a larger optical zone, thus less halos compared to LASIK for higher prescriptions, and better refractive stability, especially in higher prescriptions. Our enhancement rate is below 1% in 25,000 eyes after SMILE, he said.
The disadvantage of SMILE is that it removes a little more tissue because it starts deeper in the cornea, but there’s some evidence that because there’s no flap, the cornea is still stronger even though we are leaving less residual bed, he said.
We should be careful about not removing too much tissue, Dr. Lin said, adding “that’s where the ICL comes in.” He thinks the EVO ICL is a great technology, it doesn’t remove any tissue, and it can be reversed.
Dr. Lin noted that in Asia, there was a lot of marketing of SMILE. In Taiwan in 2020 during the COVID-19 pandemic, LASIK was around 95% of the market and SMILE was 5%. Now the number of procedures performed for SMILE is 70%, and 30% is LASIK. The transition from LASIK to SMILE in Taiwan has been driven by a combination of factors, including marketing, clinical outcomes, and patient word-of-mouth referrals.
Dr. Lin said LASIK is an amazing procedure, it’s been around for so long, and patients ask for it. To perform SMILE, you must invest in a new laser. So if patients are not asking for SMILE and you are already an expert LASIK surgeon, you are not going to perform SMILE. Doctors want to do what’s best for their patients, so if they’re not as good at SMILE but good at LASIK, they’re going to do LASIK, he said.
Dr. Lin added that SMILE is easier to perform in patients with higher prescriptions because the lenticule will be thicker and more easily removed. In an Asian population, the average prescription of patients seeking refractive surgery is more than –5.50 D, so it’s easier to remove the lenticule. In the U.S., the average prescription of patients seeking refractive surgery is around –3.50 D, so it can be difficult to remove the lenticule if the surgeon is not experienced in performing SMILE.
Dr. Lin became interested in SMILE shortly after it was approved and learned how to do the procedure in China with a friend who had experience with it. He noted that patient selection is key, especially for early cases. “You want to pick patients who won’t do as well with LASIK.”
Most patients are referred by word of mouth, so they’re coming in and asking it. “We’re one of the few practices that is known for SMILE. We’ve done more than 25,000 SMILE procedures,” he said.
The EVO ICL was marketed more than SMILE in the U.S. The ICL was first approved in the U.S. in 2005, but there wasn’t a good version, and there was a 1% incidence of cataracts forming, which is high when you perform so many cases, he said.
Dr. Lin said the improved EVO ICL, approved in the U.S. in 2022, can be a good option when patients don’t qualify for LASIK or SMILE because there is no removal of corneal tissue. It also produces the best quality of vision, he said, especially in prescriptions over –6.00 D, and many patients gain lines of vision compared to their vision with glasses. However, he did note the more expensive price tag for the ICL compared to LASIK or SMILE.
LASIK has been around for 30 years and is the standard in the U.S., Dr. Lin said, but in Asia, it’s a different story. More than 70% of patients in Japan choose the ICL, compared to 30% for LASIK; SMILE was only recently approved there. Taiwan doesn’t have the ICL yet, but surgeons there are doing a lot of SMILE, which currently holds 70% market share.
In his practice, Dr. Lin is treating around 25% with the ICL, less than 20% with LASIK, less than 20% with PRK, and the rest with SMILE. He said there is great potential for refractive procedures in the U.S., just looking at the large number of contact lens wears. With a contact lens dropout rate of 10%, there are millions of people who don’t want to wear glasses who can benefit from procedures like ICL surgery, SMILE, and LASIK.
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Input from industry
Dr. Lin asked representatives from STAAR Surgical and Zeiss to share details on what they’re seeing in the refractive market.
EVO ICL (STAAR Surgical)
The company noted that the growth of the EVO ICL outside the U.S. and the emergence of lens-based centers outside the U.S. is a signal the world is likely headed toward more lens-based procedures. They added that U.S. ICL sales were up 22% in Q4 of 2024 and 19% in FY24, which outpaced the refractive market. While the U.S. refractive procedure volumes are down, EVO ICL numbers continue to grow.
The company said more than 3 million EVO ICLs have been sold worldwide.
They also highlighted the education, learning opportunities, and onboarding to help ophthalmic professionals successfully implement and use the EVO ICL. The company stressed the benefits of the EVO ICL, notably that it does not require removal of corneal tissue or the natural lens and can ultimately be reversed. It doesn’t cause dry eye syndrome and has been shown to be safe and effective.
SMILE (Zeiss Medical Technology)
Zeiss Medical Technology was the first company to commercially introduce keratorefractive lenticule extraction (KLEx) performed with SMILE globally in 2011 and in the U.S. in 2017. During that time, data provided by Zeiss shows the rapid adoption of SMILE surgeries around the world. By 2024, more than 10 million procedures had been performed with SMILE. The company launched its second generation of the VisuMax 800 in 2021. SMILE pro surgery is performed on the VisuMax 800, a femtosecond laser with robotic assistance for easy cyclotorsion adjustment and centration aid.
Zeiss sees patient education as a key factor going forward to ensure the market understands all of the options available. Beyond education efforts, SMILE has been supported by robust clinical evidence, including more than 500 peer-reviewed papers. SMILE procedures account for approximately one-third of the refractive laser market in China and approximately 80% of the refractive procedure volumes in Korea, according to the company.
About the physicians
Yoshihiro Kitazawa, MD
Chief Medical Director
Eye Clinic Tokyo
Tokyo, Japan
Robert T. Lin, MD
Founder, IQ Laser Vision
Assistant Clinical Professor Emeritus
David Geffen School of Medicine at UCLA
Los Angeles, California
Boris Malyugin, MD, PhD
Professor of Ophthalmology
UCLA Department of Ophthalmology
Stein Eye Institute
Los Angeles, California
Relevant disclosures
Kitazawa: None
Lin: ArcScan, STAAR Surgical, Zeiss
Malyugin: None
Contact
Kitazawa: yoshihirokitazawa@gmail.com
Lin: drlin@iqlaservision.com
Malyugin: boris.malyugin@gmail.com
