The surgeon’s display during the LenSX (Alcon) procedure
The surgeon’s display during the LenSX (Alcon) procedure
If you want to engage in a spirited discussion, just mention femtosecond cataract surgery in a crowd of eye care professionals. A few familiar terms will be thrown around regarding its current and future potential—capsulorhexis, limbal relaxing incisions, reduced phaco times—but you’ll also probably hear numbers and clarifiers that would be sobering to even the most Pollyannaish proponent: roughly $500,000 to $600,000 for the laser plus “click” fees per procedure, with no increased Medicare reimbursement.

With substantial costs to patients and surgeons alike, and few evidence-based studies that show any meaningful safety benefit over conventional techniques, many ophthalmologists—and the optometrists who refer to them—wonder: Is it worth it?

Field of Dreams
Since arriving in cataract surgery suites about four years ago, the femtosecond laser has been the quinessential, “If you build it, they will come” device—with “they” being surgeons and ambulatory surgery centers to make the investment, optometrists to recommend and comanage the procedure and, of course, patients to pay for it all. (Medicare took a pass.)
So, have they come? Not in droves, but momentum among surgeons seems to have picked up of late.

“Femtosecond corneal incisions are on the way to becoming an improvement over bladed incisions,” says William Trattler, MD, director of cornea at Center for Excellence Eye Care in Miami. However, “with each laser platform, there are some surgeons that still prefer bladed incisions.”

A reader survey in the March 2014 Review of Ophthalmology found that use of the femto laser jumped from 8% in 2013 to 23% in 2014, according to the 142 cataract surgeons who responded to the survey. However, resistance remains robust. Of those respondents who do not currently use a femto laser for cataract surgery, 73% say they are unlikely to begin in the next 12 months.

Optometrists who work closely with surgeons get first-hand exposure to femto’s greater precision, and tend to be bullish on its benefits.

Walt Whitley, OD, MBA, director of optometric services at Virginia Eye Consultants, says the femtosecond laser has been an integral part of his practice and has taken cataract surgery to the next level, but he notes that there is little hard evidence that it has made a difference in refractive outcomes.

 “Overall, cataract surgeons do a great job and get great results. The question that remains is whether we can improve on our results in a consistent manner, especially when patients are paying additional fees for [premium] IOLs to enjoy spectacle independence?” says Dr. Whitley. His practice is currently gathering preliminary data to measure their outcomes.
Dr. Whitley says the doctors at his practice feel that the femto does bring added safety to the procedure.

“Patients with Fuchs’ dystrophy or PXE are great candidates for the femto due to the decreased phaco power and decreased phaco time,” Dr. Whitley explains, “which leads to less inflammation.” Unfortunately, there are limited peer-review studies available to support that impression.

Potential Benefits of Femto

Clinical results, peer-reviewed evidence and cost-effectiveness will ultimately determine the level at which femtosecond laser technology is clinically embraced in the years to come. Further prospective clinical trials are needed to evaluate femto’s impact on the quality of cataract surgery and outcomes.6

Although a landmark study has yet to be published that shows improved outcomes of clinical significance when cataract surgery is performed in conjunction with the femtosecond laser, several reports have indicated the potential benefits of femto vs. traditional cataract surgery.

> The femtosecond laser platform reduces effective phaco time (EPT) and the mean phaco energy during lens fragmentation and provides precise and reproducible capsulotomies.1

> In a prospective, consecutive, single-surgeon case-control study, there was a 96.2% reduction in EPT between controls and the femtosecond group. The latter demonstrated 36.1% reduction in endothelial cell loss. Visual and refractive outcomes were similar to those of conventional cataract surgery.2

> The significant reduction in effective phacoemulsification time correlates positively with the preoperative lens opacity.3 In other words, more advanced cataract cases—which would likely require above-average phaco time—can be done with less phaco.

> Anterior segment inflammation was less prevalent after femtosecond laser-assisted cataract surgery than after manual cataract surgery, and this appeared to be due to the reduction in phacoemulsification energy.4

> Depending on the energy level used, the strength of laser capsulotomies had a two- to threefold higher break force compared with those created by the manual technique, suggesting that laser-cut capsulotomies may be more than twice as strong.6

Doctors are still waiting for the seminal study that elevates femto enough that traditional surgery no longer meets standards of care.

 “The literature on vastly improved safety and visual outcomes is limited, with traditional cataract surgery being so successful and laser-assisted surgery still being relatively new in terms of mainstream use,” says J. Christopher Freeman, OD, clinical director at nJoy Vision in Oklahoma City and president of the Optometric Council on Refractive Technology.
Although the smoking gun of femto benefits has yet to be fired, Dr. Freeman—like Dr. Whitley—offers positive and promising anecdotal evidence.

“In our practice, our surgeons are reporting most femto cataract cases with free-floating capsulorhexis and lens material removal with only irrigation and aspiration, thus no phacoemulsification time and no phaco energy. Our surgeons have not reported any refractive surprises or increased level of corneal edema,” Dr. Freeman says.

Despite the absence of a hallmark study, there is data in the literature supporting laser-cut capsulotomies resulting in greater accuracy and predictability, Dr. Freeman notes (“Femto at a Glance”).

Eric Donnenfeld, MD, immediate past president of ASCRS, says the clinical benefits of femtosecond laser cataract surgery are fourfold:

1. The primary incision allows the surgeon to create a uniform and consistent three-plane incision with a self-sealing reverse side cut, which has the potential to reduce the incidence of endophthalmitis.

2. Incisions are more accurate, safer and reproducible.

3. Capsulotomies are more precise.

4. The procedure is safer.

“Lens fragmentation has been the greatest surprise in my experience,” Dr. Donnenfeld says.

“When I started performing femtosecond laser cataract surgery three years ago, the procedure took four minutes and reduced my phaco time by 33%. Today, the procedure takes 40 seconds and I use no phaco time on 65% of my cases and my overall phaco time is reduced by over 80%,” Dr. Donnenfeld says. “My expectation is that in a few years there will be almost no phaco performed on my cataract surgeries done with the femtosecond laser.”

Overall, femtosecond arcuate incisions appear to be a major upgrade over bladed arcuate incisions for correcting astigmatism, according to Dr. Trattler. “Since these incisions are image-guided, surgeons can design patterns that are uniform in height, length and depth. These incisions, once made, can be opened intraoperatively, which provides the full effect for reducing astigmatism—or they can be placed and opened postoperatively,” Dr. Trattler says.

For Your Practice
Stack up all the pros of femto and you’re still left with a substantial hurdle: cost. Clinicians continue to debate whether the pluses of using a laser justify the dollars it takes out of the practice budget, or patients’ pocketbooks.

When traditional cataract surgery is both successful and covered by insurance, is the laser worth its hefty price tag?
The machine alone costs about a half-million dollars. Then there’s a usage fee that comes in between $150 and $400 per eye, and maintenance costs of between $25,000 and $50,000 per year after the initial warranty has expired.

According to Dr. Donnenfeld, the cost of the procedure is indeed the major limiting factor for most physicians and patients.
“Purchasing a laser and maintaining it requires a significant financial investment,” he says. “For surgery centers with volumes of over 2,000 cases, that is usually manageable.” For surgery centers with lower volumes, a so-called ‘roll-on, roll-off’ mobile laser method might be a better option, he says. This allows practices to lease the costly equipment on an as-needed basis.

According to Dr. Freeman, there are several ways to address the costs associated with the laser.

A surgeon may charge the patient for the use of the laser in two instances: imaging that is a component of femtosecond lasers and astigmatism correction as part of a refractive procedure. Facilities can bill for the use of femto in connection with premium IOL implantation with certain limitations.

The cutting component of the laser is considered a covered charge and the imaging component is considered a noncovered charge. The additional charge to the patient must only be related to the noncovered imaging component.

According to Dr. Freeman, most surgeons bundle the costs of using the laser into their refractive cataract surgery package as an included service in premium IOL surgery with a refractive outcome.

Payment plans offered by many practices make the procedure more affordable to patients, similar to the approach used when marketing LASIK.

For Your Patients
Sure, your patients will pay more out of pocket, but many of them see the improved technology as a good investment in their future vision, Dr. Donnenfeld says.

“Obviously, patients who pay for a premium procedure have higher expectations, but this is the challenge refractive cataract surgeons and their referring optometrist must meet to be successful in this field,” Dr. Donnenfeld says.

According to Dr. Donnenfeld, about 75% of patients are within half a diopter of emetropia with the femto laser—a number that has traditionally been about 40% to 50% with conventional surgery; however, if his patients do not end up with their desired outcome with the femto, his practice offers LASIK at no cost to correct their vision. This brings his practice’s results to over 95%.

It is the eye care provider’s responsibility to educate the patient as much as possible and let them decide whether or not they see the value in what’s being offered, Dr. Whitley says.

 “Our role is to educate our patients on the available options, match the patient with the technology and the technology with the patient, and make a recommendation,” Dr. Whitley says. “Patients need to understand that cataracts are an inevitable part of aging and there are numerous treatment options available to them.”

Scott Hauswirth, OD, with Minnesota Eye Consultants in Minneapolis, said patients who opt for laser technology tend to have high expectations and need proper preoperative education. “The use of laser technology in an arena with a ‘normal’ patient and an already good surgeon does not eliminate the time needed for visual recovery, adaptation to an IOL or potential for slight residual refractive error, but it does definitely heighten the patient’s mental awareness of what they experience postoperatively,” Dr. Hauswirth says. “These patients require some additional chair time either before surgery or afterwards to remind them that, while this is a laser procedure, it is still not the same thing as excimer laser refractive surgery.”

 
Image illustrating the real-time anterior chamber during a four-quadrant lens chop and capsulorhexis with the LenSx system.
According to Dr. Freeman, the happiest patients are those whose expectations are met, with no surprise outcomes. But he admits that there can be challenges when discussing new technology.

“Because femtosecond lasers for cataract surgery are relatively new, but early experience is positive with successful surgeries and excitement by surgeons, it’s difficult to tell patients that it is definitely safer, especially for already excellent surgeons who have low complication rates,” Dr. Freeman says.

That being said, he expects that surgeons will eventually embrace femto for cataract surgery in much the same way they abandoned the blade after they started using the femto for LASIK flaps.

Dr. Freeman points out that surgeons were skeptical then, as they are now, but “once surgeons start experiencing the precision of the free-floating capsulotomies and crystalline lenses softened to the point of only requiring irrigation and aspiration, with clear quiet eyes and successful outcomes, they will make the femtosecond laser their procedure of choice for cataracts.”

Increased Value of Comanagement
Femtosecond laser cataract surgery is an ideal opportunity for strong and mutually beneficial comanagement.
“The higher expectations and multiple surgical options of patients undergoing cataract surgery today demand a more thorough informed consent and a knowledge of the patients’ visual needs,” Dr. Donnenfeld says. “Postoperatively, these patients require more frequent evaluation and refraction to fine-tune results. This creates the perfect situation for optometrists and ophthalmologists to each do what they do best to manage patients and achieve the highest level of patient care.”

From Dr. Hauswirth’s perspective, patient selection, coaching and preoperative lens calculations have created the greatest amount of pressure surrounding the newer femto and IOL technology. He says the postoperative refraction—as well as the patient’s perspective of it, for better or worse—is a downstream effect of those criteria.
Femto: At a Glance
Femtosecond laser technology uses a proprietary optical coherence tomography (OCT) system to provide real-time images of the anterior segment.5 It integrates high-resolution imaging with laser technology to perform key surgical steps with computer-guided precision. Such lasers have been in use for several years, typically to create corneal flaps during LASIK.6 Below is an overview of how femto works.5

To perform a cataract procedure, the surgeon first programs the laser for the corneal incisions and the capsulotomy, and then the lens fragmentation pattern. Next, the eye is docked to the laser and the integrated OCT captures three-dimensional images of all ocular structures within the anterior segment. The captured images are projected onto the video microscope screen along with overlays of the preprogrammed laser treatment.

The surgeon then makes any adjustments via touch screen and begins the treatment.
Because femtosecond lasers work from the inside out, the cataract procedure is carried out in reverse compared to a standard surgery. The lens is fragmented first, then an anterior capsulotomy is created and finally the corneal incisions are made, usually to 90% depth, as the laser elements of the surgery take place outside the surgical suite in a nonsterile environment. Once in the OR, the surgeon completes the corneal incisions manually, removes the capsulorhexis disc, uses irrigation/aspiration to remove the fragmented cataract, and performs cortical clean-up. At this point, the surgeon implants the IOL.

 

When ODs select the best candidates for femto, explain the procedure and expectations in detail, and provide surgeons with the most accurate lens calculations possible, the optometrist and surgeon can plan a realistic and reachable postop refraction target.

“The referring doctor plays a vital role in identifying and then communicating patients’ visual demands and goals to the surgeon and a target of plano sphere, or -0.50 sphere in the non-dominant eye, for example,” Dr. Freeman says.

Dr. Hauswirth notes that it’s critical that ODs work with skilled and progressive surgeons who understand the limitations of the technology. “Selected ophthalmologists may succeed or fail based on our referrals, which should be reflective of their skill and willingness to collaborate with us in our patients’ best interests,” Dr. Hauswirth says.

Diagnostics and clinical management are the OD’s greatest strengths, so he doesn’t propose that they take a station in the operating suite with surgeons, but he does reiterate that optometrists need to stay informed about all types of ophthalmic surgery to help with informed decision-making, “as well as be prepared to manage patients following surgery.”

Any respectable OD would agree that communication is essential in virtually any patient relationship, but it’s particularly crucial with regards to what they can expect after femto cataract surgery, especially if those expectations—and their personal financial burden—is high.

Thanks to Dr. Freeman and Tracy Swartz, OD, MS, optometrist at Madison Eye Care Center in Madison, Ala., and member of the Optometric Council on Refractive Technology, for their contributions to this article.

1. Reddy KP, Kandulla J, Auffarth GU. Effectiveness and safety of femtosecond laser-assisted lens fragmentation and anterior capsulotomy versus the manual technique in cataract surgery. J Cataract Refract Surg. 2013 Sep;39(9):1297-306.
2. Abell RG, Kerr NM, Vote BJ. Toward zero effective phacoemulsification time using femtosecond laser pretreatment. Ophthalmology.  2013 May;120(5):942-8.
3. Mayer WJ, Klaproth OK, Hengerer FH, Kohnen T. Impact of crystalline lens opacification on effective phacoemulsification time in femtosecond laser-assisted cataract surgery. Am J Ophthalmol. 2014 Feb;157(2):426-32.
4. Abell RG, Allen PL, Vote BJ. Anterior chamber flare after femtosecond laser-assisted cataract surgery. J Cataract Refract Surg. 2013 Sep;39(9):1321-6.
5. Cunningham D. Femtosecond Lasers in Integrated Eye Care. Rev of Optom. 2011;148(3):115-25.
6. Roberts T, Lawless M, Colin CK, et al. Femtosecond laser cataract surgery: technology and clinical practice. Clin Experiment Ophthalmol. 2013 Mar;41(2):180-6.