Imagine being a typewriter salesman at the dawn of the personal computer revolution, staring down the threat of a disruptive technology that might render your product obsolete. That’s how some optometrists started to feel in the 1990s, when the concept of refractive surgery finally shifted from oddity to reality. For a century, optometrists had been the go-to representatives for refractive eye care, which, until that point, meant the dispensing of glasses and contact lenses. The picture suddenly changed in 1995 when the FDA approved the excimer laser for photorefractive keratectomy (PRK). Boosters talked breathlessly about how this could eliminate the need for corrective lenses forever.
From the start, questions abounded on what this new subfield of eye care meant for optometrists and their patients.
“There’s a lot for optometrists to be concerned about and very few clear answers at this time,” said Michael Moretti, editor of Medical Laser Insight, in Review’s October 1995 article on incorporating PRK into the optometric practice. “There will be PRK centers established on the optometrists’ ‘turf.’ Individual practitioners need to make some strategic decisions.”
|Refractive surgery was a hot topic as ODs pondered their role in delivery of care.|
“The more I’ve looked into the PRK industry, the more apparent it’s become that these companies are operating from this assumption: whoever owns the laser is in control, and whoever is in control gets the lion’s share of the fees,” said Jack Melton, OD, in the same article.
Things got even more heated—and public interest boomed—when the FDA approved an excimer laser for performing intrastromal keratomileusis (LASIK) in 1998. The much-lauded LASIK procedure was under the sole domain of ophthalmologists, and largely eliminated the need for postoperative correction. (See “Laser Refractive Surgery Through the Years.” )
It looked like optometrists might get cut out of the picture entirely.
To make matters worse, another problem had arisen at much the same time: the field of ophthalmology was undergoing increasing specialization, which placed further pressure on its members to enter this new area of eye care.
“Increasing competition for surgery and general eye care is changing the structure of ophthalmology,” noted an article in Review a decade before the 1990s refractive surgery boom (“Ophthalmology’s Fragmented Future,” February 1987). “Thanks to increasing pressure on health care costs, pre-paid providers are controlling a greater and greater share of eye care and eye surgery,” the article noted. “To cut costs, these providers are now experimenting with taking eye care and eye surgery away from the average ophthalmologists and channeling it towards circles of optometrists surrounding one or two specialized surgeons.”
Laser Refractive Surgery by the Numbers
In the early days of laser vision correction, just after LASIK was approved, its popularity exploded—from about 100,000 procedures in 1996 to 1.4 million in 2000—a 14-fold increase in just five years.1 LASIK had quickly become the most common refractive procedure in the world. But then in early 2000s, the dot-com bubble popped, and the volume of procedures dipped for a few years. In 2004, the number of laser refractive surgeries nearly recovered to that high water mark of the year 2000, but never surpassed it. The numbers plateaued just beneath 1.4 million for the following three or four years. Then in 2007-2008, the housing bubble burst. The economy took a nosedive and laser refractive surgery—typically an elective procedure—followed the plunge. The numbers bottomed out in 2011-2012 at about 600,000 procedures a year, less than half than that of its high point. The number of procedures has edged up a little bit since, but it’s clear that laser refractive surgery never fully took over the eye care world, as many people back in the late 1990s had expected it would. “We learned in LASIK to follow the consumer confidence data,” said Randall Fuerst, OD, who recounted the ups and downs of his refractive surgery-based practice in a 2012 article. “If consumer confidence rose, almost invariably LASIK volume rose. Conversely, if it dropped, LASIK volume dropped.”
Even ophthalmic surgery itself was becoming more specialized, which was causing specialists to eat up business. Ophthalmology’s 85 residency programs were pumping out 500 ophthalmologists per year at that time, which crowded the field even more. In addition, medications were becoming increasingly regulated and the level of optometry education was growing, which further threatened ophthalmology.
The discipline of laser surgery seemed like the perfect place for industrious ophthalmologists to move into, especially given the growing patient interest.
And move into it they did. “Look at attendance at ophthalmologists’ continuing education courses; the laser courses are jammed,” noted George White, OD, in a September 1989 article.
Can’t Beat ‘em? Join ‘Em!
So what were optometrists to do?
Some stayed out of the game entirely: in an October 1995 survey of 500 Review of Optometry subscribers, 62% reported no affiliation with a laser center and no plans to join one.
Other optometrists tried to get in on the action (not to mention protecting their patients) by taking the role as patient educators and advocates. “Consumer interest in excimer laser PRK is already high, especially among young contact lens wearers, [with] more than half of all potential PRK candidates [interested in seeking] the advice of their regular eye doctor prior to undergoing the procedure,” a separate 1995 survey reported.
What’s Next for Refractive Surgery?
On the horizon are several technologies and ancillary techniques that may help further prevent postoperative LASIK complications while expanding the pool of surgical candidates. Corneal collagen crosslinking is the most notable, achieving FDA clearance earlier this year for this technique, which strengthens the bonds of the cornea and possibly reduces post-LASIK ectasia. Some refractive surgeons are combining corneal crosslinking with LASIK or PRK in non-keratoconic patients as a prophylactic measure to stiffen the postsurgical cornea.
LASEK may yield better refractive results than traditional LASIK in patients with high degrees of myopia, while SMILE—a small-incision lenticule extraction procedure in Phase III trials—may exhibit a lower induction rate of higher-order aberrations and spherical aberration, and less postoperative dry eye, than LASIK.1,2 The field of laser-guided topography also continues to grow with the expectation of successful use on increasingly irregular corneal surfaces. More sophisticated screening technologies will continue to improve the ability of optometrists to screen refractive surgery patients and educate them about procedure eligibility.
Still others postulated that “some referring doctors will perform these procedures at the centers themselves, [while] doctors who don’t have the skills will use the centers to obtain access to trained consultants—much like what we’ll see with the excimer PRK centers that are forming around the country.”
“This is a logical extension of what optometry has always done,” said Jim Thimons, OD, in a 1989 article when asked whether optometry was ready for laser surgery. “Optometry has historically been the profession most knowledgeable about light and light energy as it relates to optics. We don’t see this as surgery but as a refractive procedure. Surgery by strict definition is a technique used to cure a disease. Refractive problems are not a disease.”
Although ODs have yet to gain authorization to perform LASIK surgery, the prediction that optometrists would ultimately share the spotlight with ophthalmologists wasn’t so far off. Today, ophthalmologists continue to be the sole providers of LASIK and other surgical procedures, but optometrists are often responsible for preoperative patient education and postoperative care, including the treatment of dry eye and other complications using topical medications or contact lens fittings. (See “What’s Next for Refractive Surgery?”)
Optometrists who embraced the changes wrought by the advent of refractive surgery evolved with it. The sudden appearance of a surgical boom allowed ODs to build up the skills needed to comanage patients. It better integrated them into the fabric of the health care system and broke down barriers with ophthalmology.
“Specialty services and refractive surgery comanagement are where I’m headed,” a Washington state optometrist mentioned as part of his response to Review of Optometry’s 9th Annual Income Survey in 1995.
Fast forward 15 years. By 2010, the fears of LASIK draining patients from optometrists’ offices had disappeared. If anything, patients’ concerns of LASIK mishaps—widely popularized at the time—had helped to keep patients in ODs’ exam chairs.
Laser Refractive Surgery Through the Years
• 1896. Surgical alterations to the eye began to be seriously considered in this year when Lendeer Jans Lans, an ophthalmology teacher in Holland, published theoretical work on the potential for cutting the cornea to correct astigmatism. Two years later, Lans incorporated electrocauterization to heat the corneal stroma in an attempt to alter its shape. This technique was later adopted under the name thermokeratoplasty in 1975.1,2
• 1949. The “father of refractive surgery” ophthalmologist Jose Ignacio Barraquer, MD, of Bogota, Colombia, published an article on the concept of lamellar refractive surgery, in which the addition or subtraction of lamellar tissue could modify the cornea’s refractive power. Dr. Barraquer invented a small handheld keratome, similar to a carpenter’s plane, which he used to resect layers of corneal tissue.3,4
• 1974. Russian ophthalmologist Svyatoslov N. Fyodorov, MD, inadvertently performed the first radial keratotomy procedure on record when he removed glass shards from the eyes of a boy who had fallen off of his bicycle. The rudimentary procedure employed a series of manual cuts that ultimately led to a reduction in the boy’s nearsightedness.5
• 1981. Excimer laser technology was introduced to the field of vision correction when Rangaswamy Srinivasan, PhD, a scientist at IBM, discovered that ultraviolet light emitted from an argon-fluorine (ArF) excimer laser could be used to precisely ablate fine layers of living tissue with little to no damage to the surrounding area.6 His first test of the laser was on bone and cartilage from his leftover Thanksgiving turkey, in which he proved that the excimer laser could make precise cuts without burning underlying material.7
• 1983. In collaboration with Dr. Srinivasan, Stephen Trokel, MD, an associate professor of ophthalmology at Columbia University, performed the first excimer laser photorefractive keratectomy (PRK)—which he termed “ablative photodecomposition”—on cow and cadaver eyes.8
• 1988. Working with Dr. Trokel, Marguerite McDonald, MD, of Louisiana State University, performed the first PRK procedure on a normally sighted eye in a living human subject—a 61-year-old patient who’d been diagnosed with malignant melanoma.9
• 1989. The idea for LASIK appears in two separate places at the same time. Greek ophthalmologist Ioannis Pallikaris, MD, PhD, described the basic technique we now call LASIK, in which the surgeon uses a microkeratome to create a corneal flap prior to application of the excimer laser, as in PRK; he performed the first procedure on a human eye that year.10 Meanwhile, in New Orleans, Gholam Peyman, MD, applied for and received a patent for a similarly described procedure.11
• 1995. The FDA approved the first excimer laser for PRK, Summit Technology’s Eximed System.
• 1998. Ophthalmologist Fred Kremer, MD, received FDA approval for the first excimer laser system indicated specifically for LASIK.
• 2001. The FDA approved the first bladeless femtosecond-assisted LASIK system, made by IntraLase. Investigators have found bladeless LASIK to be just as safe, predicable and stable as conventional LASIK, but better in terms of efficacy and safety.12
• 2002. Following its introduction with PRK in 1999, wavefront-guided analysis for LASIK was approved for customized correction.
In 2009, the FDA, the National Eye Institute and the Department of Defense launched the LASIK Quality of Life Collaboration Project to determine the percentage of patients who developed difficulties with their daily activities as a result of LASIK.1
The study took five years to complete, and the top findings included:
• Up to 45% of patients who had no visual symptoms before surgery reported at least one symptom at three months after surgery.
• Halos were the most common new visual symptom—about 35% of patients developed halos by three months post-LASIK.
• Up to 30% of patients who didn’t have dry eye before LASIK reported dry eye symptoms at three months after LASIK.
Although this study quantified the extent of the problems, the results were not exactly unexpected. Optometrists had been hearing such complaints from actual patients for years.
But recently, a new development has emerged in the care of refractive surgery patients.
“Interestingly, many of refractive surgery’s ‘early adopters’ (i.e., those who had a procedure in the mid-1990s) have already reached age 50 to 60, and we are now beginning to see them return with visually significant cataracts and presbyopia,” wrote Maynard Pohl, OD, in a November 2013 article.
All this just goes to show that there may be some truth to the adage: “Everything old is new again.” Or perhaps in the case of laser refractive surgery, it should be: “Everything new grows old someday.”
Thanks to Joseph P. Shovlin, OD, of Northeastern Eye Institute and Eric Donnenfeld, MD, of TLC Laser Eye Centers, for assistance with this article.
|1. U.S. Food and Drug Administration website. LASIK Quality of Life Collaboration Project. Available at: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/. Accessed July 5, 2016.|