Continuing advancements spur growth in refractive surgery field
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Refractive surgery has been a special interest since I helped the late George O. Waring III develop the study protocol for and served as a surgeon in the NEI-funded Prospective Evaluation of Radial Keratotomy study starting in 1979.
Today, I like to categorize refractive surgery as cornea based and lens based. We have robust refractive corneal surgery and refractive lens surgery verticals in ophthalmology with some overlap. Before sharing a few thoughts, I disclose that this is a field in which I consult and invest widely (see disclosures below).
First, refractive corneal surgery. Radial keratotomy has been replaced by laser corneal refractive surgery except for a few surgeons who still do two- and four-incision mini-RK as an enhancement tool after refractive lens surgery. LASIK remains the dominant corneal refractive procedure in the U.S., and most corneal flaps are created with a femtosecond laser rather than a bladed microkeratome. LASIK dominates over PRK because visual rehabilitation is faster and pain significantly less. Much like the transition to phacoemulsification in lens-based surgery, patients drove this preference more than surgeons as LASIK is technically more challenging and more expensive to perform than PRK. However, PRK remains a preferred option for many, and if pain could be managed and visual rehabilitation shortened, I believe PRK would see a resurgence in popularity.
An innovative startup company, TherOptix, is developing a low-dose anesthetic-eluting bandage contact lens that may eliminate post-PRK pain with no impact on corneal re-epithelialization. A properly designed and powered contact lens can also provide the PRK patient with functional vision immediately after surgery when pain is eliminated. If this or a similar contact lens becomes available, I predict PRK will become more popular with surgeons and patients.
Stromal lenticule extraction techniques, such as SMILE from Zeiss, require only a femtosecond laser and are popular outside the U.S. Adoption in the U.S. has been slower. Newer femtosecond lasers are being developed that can create a LASIK flap but also perform SMILE. In addition, one can imagine a femtosecond surgical workstation that might be used to create LASIK flaps, perform stromal lenticule extraction, deliver precise arcuate keratotomy incisions for astigmatism management and deliver everything required by the surgeon who performs femtosecond laser-assisted cataract surgery (FLACS). One laser for LASIK flaps, SMILE, astigmatic keratotomy and FLACS. Lensar is a pioneer in creating such a multipurpose femtosecond laser surgical workstation.
While laser corneal refractive surgery procedures grew strongly during the pandemic, case volumes have unfortunately fallen off the last two quarters as mask wearing has declined, consumer confidence has plummeted, and the external economic environment has deteriorated. Refractive lens surgery, on the other hand, continues to show good growth driven by improved technology and increasing surgeon entry into the field. We have at most 2,500 corneal refractive surgeons in the U.S., but one could argue that all the nearly 10,000 cataract surgeons in America are refractive lens surgeons, as every cataract surgery is arguably refractive surgery.
According to Market Scope, premium IOL implantation is approaching 20% of cataract surgery in the U.S. and has replaced LASIK as the most common refractive surgery. Continuing growth is expected, and heavy investment is supporting new technology development and surgeon training. Lens-based refractive surgery includes refractive cataract surgery, refractive lens exchange and phakic IOLs. In my opinion, this category represents the greatest financial opportunity for most anterior segment surgeons and industry.
As the age of Medicare eligibility slowly rises and the age at which our patients seek replacement of their dysfunctional natural lens declines, I can imagine a time when refractive lens surgery is primarily a cash-pay operation like refractive corneal surgery rather than a third-party pay procedure. That transition will drive many other innovations in care delivery, including same-day bilateral surgery, office-based surgery and pharmaceutical advances that will replace postoperative eye drops. All these changes will be positive for patients, their surgeons, industry and even third-party payers. An amazing win for all!
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