GREATER ACCURACYFemtosecond lasers let surgeons create a more precise capsulorhexis, which can lead to improved post-op vision.

To cut with a laser or with a scalpel? In cataract surgery, the machine vs. manual debate has been raging ever since femtosecond laser cataract surgery made its U.S. debut a little more than a year ago.

It's easy to see the allure of surgeons removing cataracts without a scalpel. So-called "bladeless" laser cataract surgery promises greater precision and improved vision outcomes when compared to manual techniques. Even the most skilled of surgeons won't make the exact same incision with a scalpel every time. Yet for all its promise, surgeons thus far have been slow to jump on the bladeless bandwagon. Fewer than 100 laser systems have been sold to date. Perhaps because facilities face significant start-up costs (the machine costs about $500,000), per-click charges and $50,000 in annual maintenance fees, which they must recoup by up-selling patients willing to pay $1,000 per eye out-of-pocket for returns to near-perfect vision. Medicare and insurance don't cover the laser's use.

We talked to ophthalmologists to find out if the addition of the laser to cataract removal is the next big thing or an overhyped, overpriced luxury you and your patients can simply do without.

Precise, accurate and safe
Patient prepping is the same for laser procedures as for traditional surgery. Instead of heading directly to the OR, however, laser patients first stop at a dedicated room for the laser portion of the procedure, which takes minutes to complete. Surgeons place a cataract-lens-like cone that's attached to the laser on top of the patient's cornea to start the critical incisions of cataract surgery. The incisions made with the laser are stable, meaning patients can sit upright and walk from the laser room to the OR (although most facilities transport them in a wheelchair). In the OR, surgeons use blunt instruments to fully open the laser incisions before inserting the phaco tip to fragment the lens, remove it and insert the new IOL. The second half of the laser procedure resembles conventional cataract surgery.

Ming Wang, MD, PhD, has performed approximately 1,000 femtosecond laser cases since adding the technology about a year ago. The director of Wang Vision 3D Cataract and LASIK Center in Nashville, Tenn., sums up laser cataract surgery's main advantage in a single word: accuracy.

Dr. Wang says that benefit is best realized during creation of the capsulorhexis — the large circular incision in the anterior lens capsule. To appreciate what surgeons face when operating manually, try freehand drawing a perfect circle on a piece of paper. Darn near impossible, right? Dr. Wang says studies have shown the capsulorhexis needs to offer predictable size and a precise diameter, and be perfectly centered to improve a patient's post-op vision.

He explains that inserting a new IOL into a manually created, imperfect capsulorhexis can cause the lens to shift over time. Creating a predictable, perfectly circular, perfectly centered capsulorhexis with a laser, however, results in a more predictable refraction with less astigmatism and, says Dr. Wang, more precise vision outcomes. The laser also offers the potential of eliminating phacoemulsification energy from the equation (see "Phaco-Free Cataract Surgery"), which improves the overall safety of the procedure.

David Shoemaker, MD, founder and CEO of Center For Sight in Sarasota, Fla., says femtosecond lasers deliver on the promise to deliver more precise and safer outcomes, and will be the driving force behind the inevitable merger between traditional and refractive cataract surgeries that's already — albeit slowly — happening.

"The technology will be the catalyst that forces the issue," he says. "When you consider the demographic shift — 10,000 baby boomers are turning 65 years old every day — and that patient demand for the technology is increasing, every surgeon operating on the lens needs to take a serious look at it."

ADDED BONUS Ming Wang, MD, PhD, developed a laser technique that eliminates risks associated with phacoemulsification energy.

SAFER OPTION

Phaco-Free Cataract Surgery

Ming Wang, MD, PhD, calls phacoemulsification energy cataract surgery's necessary evil. "It's an essential element of small-incision surgery, but it's also the chief culprit of the technique's common complications." Including, he says, breaking the capsular bag through the horizontal or vertical movements of the sharp phaco tip and corneal edema, inflation caused by the ultrasonic energy, that can result in long-term cornea failure and needed transplantation.

That's why the director of Wang Vision 3D Cataract and LASIK Center in Nashville, Tenn., bumped conventional femtosecond laser cataract surgery up a notch, using the laser to fragment diseased lenses in intact eyes without damaging the cornea.

In the OR, surgeons typically fully open incisions started by the laser, then use phaco energy to fragment and extract the cataract. With Dr. Wang's technique, patients enter the OR with the lens already fragmented. He floats the fragmented lens into the anterior chamber, manually chops it into smaller pieces and inserts the phaco tip. Instead of activating its energy, however, he sets it to aspirate the lens pieces out of the eye.

Dr. Wang says the technique completely eliminates complications associated with the use of phaco energy and shortens time spent in the open eye, which further enhances the procedure's safety.

— Daniel Cook

FAMILIAR FINISH Surgeons finish procedures in the OR after starting incisions with lasers in another room.

Why the resistance?
The hefty capital investment — approximately $500,000 for a new femtosecond laser system — is a significant barrier to widespread use of the technology. Add annual maintenance costs of approximately $50,000 and per-click fees in the hundreds of dollars to the equation, and there's no meat left on the cataract reimbursement bone, especially when lasers aren't included in covered services paid by Medicare and private insurers. There's no simple way to pass the additional costs on to the average patient who doesn't want to pay out-of-pocket for premium IOLs or astigmatic corrections.

Thomas Boland, MD, is a high-volume doc at Northeastern Eye Institute in Scranton, Pa., a facility he says is always on technology's cutting edge. "Even we pumped the brakes based on those start-up costs." He instead opted to perform bladeless cataract surgery with the LASIK laser the facility already owned (see "Performing LASIK? You're Halfway There").

"If your reimbursement for the case isn't going up in line with your costs, that's not a very good business model," says Dr. Boland, who knows some surgeons who've purchased laser systems and struggle to generate enough income to justify the investments.

The number of cases you'd have to host to break even can be staggering, says Dr. Boland. He figured his center would have to convert roughly 20% of its 4,000 annual cataract cases to laser procedures. "But not every patient has disposable income, so that's not necessarily an easy thing to do," he points out.

The reimbursement model is viable at high-volume centers with multiple surgeons using the laser, says Dr. Shoemaker, whose facility hosts approximately 7,000 cases a year. He's performed more than 200 laser procedures since adding the technology in July.

Dr. Boland believes the specialty will find a way to work lasers into routine cataract surgery, but with today's current technology and reimbursement models, it's not going to catch on as quickly as some experts thought just 2 or 3 years ago during the height of the technology's buzz.

The required capital investment clearly scares off budget-conscious eye centers, but there's another barrier to more widespread adoption of laser technology: emotion. "Surgeons are very comfortable with the blades they're using and resist change," says Dr. Wang. "They hesitate to learn a new way of doing things because it's different from what they're used to."

Ophthalmic surgeons have never shied away from seeking out technology — and coming up with the required capital — to improve clinical outcomes. But do lasers do that? Not according to Lawrence Piazza, MD, medical director of Coastal Eye Care and Coastal Eye Surgery Center in Ellsworth, Maine. In an op-ed piece written for the Bangor Daily News, he says medical literature fails to provide definitive clinical proof that lasers contribute to better or safer visual outcomes than purely manual techniques. He points to surgeon skill, accurate pre-op eye measurements, proper IOL selection and placement, treating pre-existing corneal astigmatisms and removing cataracts without complication as factors in excellent vision outcomes.

Then there's case times to consider, especially in a specialty that thrives on efficiency. Moving patients from pre-op to the laser room and finally to the OR can't match than the linear flow of conventional cataract surgery. In fact, the detour may even slow you down. Dr. Piazza says lasers result in a threefold increase in total surgery time compared to manual surgery — Dr. Wang concedes the burgeoning technology is not yet overly efficient, but claims he can achieve comparable overall case times — which he doesn't consider progress when both methods achieve similar post-op results.

"Do patients with laser-created incisions see better than those with manually-created incisions?" asks Dr. Piazza. "So far, the answer is no."

EYE ON COSTS You can use your existing LASIK laser to do bladeless cataract surgery, says Thomas Boland, MD

MIDDLE GROUND

Performing LASIK? You're Halfway There

Thomas Boland, MD, and his partners at Northeastern Eye Institute in Scranton, Pa., looked into purchasing a femtosecond laser cataract system, but balked at investing $500,000 in the new technology. They instead opted to use the center's IntraLase laser, which they already owned for LASIK and corneal transplant procedures, to make cataract incisions.

Dr. Boland says IntraLase lasers make 3-plane incisions, so "they're very tight, very secure and less prone to wound leaks." Surgeons program the laser to make incisions of any shape. "You control astigmatisms a little better if you can control the incision size more accurately."

He believes the technique is a middle ground between conservative surgeons who still believe in the tried-and-true success of manual cataract surgery and forward-thinking docs who tout the benefits of femtosecond lasers.

"Cataract surgeons have many tools at their disposal," says Dr. Boland. "This is a tool we happened to already have." Insurers don't yet pay for the use of lasers during cataract procedures, so the cost must be passed on to patients if they're paying out-of-pocket for upgrades such as premium IOLs and astigmatism correction. Because Dr. Boland's facility already owned the IntraLase laser, he's able to offer the technology essentially for free to patients already paying for vision upgrades.

The IntraLase laser can't make the capsulorhexis and soften the nucleus like newer femtosecond systems can, but "that wasn't hugely important to us," says Dr. Boland. "A lot of patients like the idea of an all-laser, blade-free procedure. This is one more step along that road."

Dr. Boland, who concedes he added laser cataract surgery partly to market his center to local patients, doesn't anticipate performing many procedures out of the chute. Still, he says, it's nice to have the option if patients express interest in it. He performed his first case in September, and a handful since. His initial patient was 20/25 uncorrected at 1 week post-op. "If I didn't reveal it was a different incision, you'd never know."

— Daniel Cook

Looking ahead
Dr. Wang believes lasers' hefty price tags will decrease as more generations of the technology are developed, much like today's widespread availability of smartphones compared to the first absurdly basic cell phones that cost much more. He also believes you have to invest in the future of cataract surgery. "The fundamental difference between femtosecond laser and the manual blade is like the transformation from analog to digital," he says. "It's not just better. It's entirely different."

Why is backing a fundamental change so important, according to Dr. Wang? "Because then you have unlimited potential to develop the technology further. Manual cataract surgery is maxed out. It's basically as good as it's going to get."

He says 95% of surgeons focus on the traditional goal of cataract surgery — removing the cataract. "The other 5% also want to optimize the patient's vision to near perfection. That's an entirely different goal."

Centers interested in traditional cataract surgery shouldn't bother investing in laser cataracts, says Dr. Wang, because manual blades will suffice. But if your mission is to meet the demands of patients who want high-end vision function and are willing to pay for it, laser cataract surgery is the way to go, regardless of how many cases you host, says Dr. Wang, because it will define your center as cataract surgery continues to evolve.

For all his objections to adopting laser cataract surgery today, Dr. Piazza won't completely discount the possibility of adding it to his center. "If laser-assisted cataract surgery demonstrates superior visual outcomes over traditional cataract surgery techniques, then of course I'll make the technology readily available to my patients."