Finding Your Femto Fit

Manufacturers highlight why their particular femtosecond laser platforms for cataract surgery are best for your ASC.

By Desiree Ifft, Contributing Editor

The potential benefits have been widely communicated, initial clinical results have been published or presented from the podium, early adopters are on board, and several manufacturers are cleared to place femtosecond lasers for cataract surgery in the U.S. market. And so continues the emergence of what many believe will be the first paradigm shift in decades for the country’s mostperformed surgical procedure.

Five, and soon to be at least six, companies have secured FDA approval for their femtosecond laser platforms to perform one or more of the key steps in cataract surgery: creating the capsulotomy, making incisions in the cornea, including arcuate incisions for astigmatism management, and fragmenting the lens. (See “510(k) Clearances to Date,” on page 8.) All have been able to show that their technologies improve the accuracy and precision of the key steps compared with manual performance.^1,2 They’ve also demonstrated that less ultrasound phacoemulsification energy is required to remove the lens after it’s been fragmented or softened with the laser.³ Work is also under way to evaluate whether the increased precision and decreased phaco energy lead to better postoperative vision for patients, through aspects such as more predictable and stable effective lens position, and a higher level of safety through aspects such as more secure wound architecture and less corneal endothelial cell loss.^4,5

While performance has been favorable so far across all platforms, the options differ in some respects, such as treatment algorithms, the imaging and patient interface, i.e., docking, technologies used, and the incision and fragmentation patterns available. It may be that at least some of these features will be found to have a differentiating impact on results. To help you analyze whether investing in a femtosecond laser is a good move for your ASC, The Ophthalmic ASC asked manufacturers to explain why their platforms would be the best choice.

LenSx Laser

Since Alcon launched the LenSx Laser in the United States in 2011, it has been placed in more than 100 centers. According to Vice President and General Manager, U.S. Surgical Alcon, Jim Thomas, “Our platform offers a truly premium laser experience for refractive cataract surgery.”

The LenSx Laser incorporates proprietary OCT and a video microscope. The integrated OCT provides real-time, three-dimensional visualization of the entire anterior segment, including side views of the cornea and capsular bag and topographic views of the lens, during every phase of the procedure. The system utilizes a disposable, curved patient interface, which helps to maintain a more natural corneal curvature to aid surgical accuracy. It’s also designed for patient comfort and ease of use.

Alcon’s LexSx Laser

“Clinical trials show the system is capable of producing nearly perfectly centered and sized capsulotomies and reducing the ultrasound phaco energy required to aspirate lenses,” Thomas says.⁶ “In addition, studies suggest a lower deviation in effective lens position, holding out the possibility for more predictable refractive outcomes.”⁷

Discussing patient flow and practice management issues, Thomas points out that while the femtosecond laser is an additional procedure that must be accounted for in a surgeon’s schedule, the technology can be a time-saver in other respects. “Research has shown that using the laser to fragment the lens reduces phaco time by 43% compared with traditional cataract surgery,” he says.⁶ “Because the LenSx Laser has a reasonable footprint and utilizes a detached, mobile surgical bed, it provides flexibility. ASCs can evaluate their specific situation and requirements and place the laser in the area that works best for them, whether that’s inside or outside of the OR.”

Thomas cites Alcon’s comprehensive training program and its support of a Clinical Applications team for helping surgeons and ASCs to work the laser into their routines. “Through our experience of training more than 500 surgeons globally, the feedback has been that the learning curve has been accelerated.”

Victus Femtosecond Laser Platform

As Calvin Roberts, MD, Bausch + Lomb’s executive vice president and chief medical officer, surveys the femtosecond cataract surgery landscape, he sees that surgeons who utilize premium IOLs have been early adopters of the technology. “They realize the precision of the laser allows them to provide their patients with the premium lenses’ maximum value,” he says. He cites a recent study in which capsulotomies created with the Victus Femtosecond Laser Platform, which was developed through a partnership between B + L and Technolas Perfect Vision, were statistically significantly more precise in diameter, circularity and centration than manually created continuous curvilinear capsulorhexes.⁸

The Victus Femtosecond Laser Platform, developed through a partnership between B + L and Technolas Perfect Vision

The Victus offers ASCs many advantages over other lasers, Dr. Roberts says. First, it’s not only FDA-cleared to perform capsulotomy but also for use in LASIK. “For surgery centers, this means multiple functions for one capital outlay and better use of space,” he says. The goal for B + L and Technolas is to secure additional FDA clearances for arcuate incisions and lens fragmentation for cataract surgery, uses that are already approved in Europe.

Dr. Roberts also discusses the Victus’ use of real-time OCT as a major advantage. “It’s not a snapshot where you image the anterior segment and then plan your surgery. What if the eye moves or something else changes by the time you’re ready to deliver the treatment? With real-time OCT, you know you’re where you want to be at all times and cutting in the exact right place.” Speed is a factor as well, Dr. Roberts says. “The Victus’ fast pulse rate, up to 160 kHz, enhances control and minimizes treatment time.”

The laser’s patient interface is curved to minimize distortion of the cornea. It also reduces the level of suction required compared with a flat interface, Dr. Roberts explains. “The laser doesn’t have to hold and compress, just hold. The docking mechanism also includes intelligent sensors to monitor the pressure while the eye is engaged and warn the surgeon if pressure drops or increases.”

Looking to the future, Dr. Roberts says he doesn’t expect lasers to replace ultrasound phaco, but rather that phaco will be optimized to complement lasers. He also expects surgeons will find that femtosecond laser cataract surgery can make them more efficient. He pointed to a recent conversation with a European surgeon who has been using the Victus. “In one day, he was able to perform 72 cataract operations. He took an hour off for lunch and was finished with his cases by 6 p.m.”

LensAR Laser System

Unlike other femtosecond laser platforms for cataract surgery, the LensAR Laser System doesn’t rely on OCT imaging. It utilizes a proprietary 3D-Imaging, Measurement and Guidance System. A rotating camera takes multiple scans of the eye, imaging it from limbus to limbus and from anterior cornea to posterior lens. The images are high-contrast and lownoise and they automatically detect all of the key lens surfaces. Next, ray tracing is used to create a 3-D reconstruction of the entire anterior eye. “This is true 3-D imaging that provides true biometric measurements,” LensAR CEO Nicholas Curtis says.

The LensAR Laser System by LensAr, Inc.

The system provides additional information on the degree of lens tilt and pupil decentration within the visible cornea. According to Curtis, the treatment pattern can then take into account any lens tilt and avoid inadvertent damage to the anterior and posterior lens capsule. When imaging is completed, the surgeon can choose where to place the capsulotomy, over the center of the pupil, over the anterior apex of the lens, or over the optical axis of the lens. Surgeons can program a memory stick and allow the laser to set itself up according to those parameters, or they can use the system in a more interactive way, programming and making changes for each patient. “Surgeons have been very excited to learn the nuances of the machine, how flexible it is, and how they can match it with their personal techniques to maximize efficiency,” Curtis says.

The LensAR Laser System uses a fluid-filled patient interface so as not to compress the cornea, which can lead to folds or striae. In addition, the laser is efficient from a lens fragmentation perspective, Curtis says. “We were able to present very good data to the FDA that included all four grades of cataract. Even for very hard cataracts, the amount of ultrasound phaco energy required to remove lenses is greatly reduced.⁹ For some cataracts, it can even be eliminated.”

Ergonomically, the LensAR laser was designed with ASCs in mind, Curtis says. “It allows the doctor to approach the patient from any position. It’s movable, but it can also be used in one room only with a standard gurney, which is ideal for patient flow. The laser head deploys to the patient with the push of a button. It can then be moved out of the way in the same manner, so the surgeon can swing his or her microscope into place to finish the case.”

LensAR will soon initiate a full clinical trial to further evaluate its femtosecond laser procedure to restore the accommodative power of the crystalline lens. “We have primate data showing no cataract progression as long as 5 years after the procedure,” Curtis says.

Catalys Precision Laser System

When OptiMedica President and CEO Mark Forchette talks about his company’s Catalys Precision Laser System, he emphasizes how its “unique features create a synergy that delivers unparalleled precision and accuracy.”

Among those features is the laser’s Integral Guidance system. It includes state-of-the-art OCT with proprietary surface detection algorithms to automatically identify the ocular surfaces and automatically apply the surgeon’s plan to the patient’s unique anatomy. “The surgeon simply confirms the automated 3-D treatment plan and delivers the laser,” Forchette says. “Also, because Integral Guidance registers surfaces and customizes treatment in 3-D, docking-induced ocular tilt is a non-issue.”

The graphical user interface and template-based planning software of the Catalys allows each patient’s treatment to be pre-planned, which fosters efficient work flow and shortens the time the patient is under the dock. When it comes to patient docking, OptiMedica’s approach is fundamentally different from that of other platforms, Forchette says. It’s based on a fluid-filled Liquid Optics Interface designed to ensure low intraocular pressure rise, prevention of corneal folds, an optimized optical path for the laser, and patient comfort. “Our laser is also a rocket ship in terms of speed, which enhances precision and safety,” he added. “Cases average about 3 minutes from start to finish.”

The Catalys Precision Laser System from OptiMedica

“All of these features are impressive on their own,” Forchette continues, “and when added together give us what we see in our clinical data. For example, a randomized study comparing manual cataract surgery to laser surgery with Catalys showed the system produces capsulotomies within 30 microns of in tended size and 80 microns of intended center, with exceptional circularity. In addition, 99% of the capsulotomies in the study were free-floating. Interestingly, the study included large numbers of difficult patient subsets, including those with corneal scars, posterior synechiae, white cataracts and small pupils, who were treated successfully.”¹⁰ In another study, laser lens fragmentation with Catalys was shown to reduce effective phacoemulsification time by 96%.¹¹

OptiMedica relied heavily on doctors and nurses to develop the work flow aspects of the Catalys, one result of which was the inclusion of an integrated bed and custom headrest. “They’re part of what ensures the consistency and reproducibility of the procedure,” Forchette says. “Surgery centers find the laser easy to integrate because they can place it either in the OR, where surgeries can be performed on the integrated bed, or in a separate room.”

Because the Catalys is elegantly sophisticated yet easy to use, it has virtually no learning curve, Forchette says. “A registry study we conducted tracked our first centers’ initial 100 cases and confirmed very high success rates even in the surgeons’ earliest cases. Centers that expect to use the laser in 25% of their cases, are usually up to 40%, or higher, within their first few months. They find that any misconceptions they may have had about being slowed down by the technology were wrong.”

Femto LDV Z6 from Ziemer

The Catalys was launched internationally in November 2011 and in the United States in February 2102. Since then, it’s been installed in more than 20 ophthalmic practices in seven countries and been used to perform more than 3,000 laser cataract procedures.

Femto LDV Z6

Frank Ziemer, president and CEO of Ziemer Group, says his company is “close” to filing with the FDA to obtain 510(k) clearance of its Femto LDV Z6 laser for cataract applications. The Z6 is already cleared for the creation of corneal incisions in patients undergoing LASIK, tunnels for the implantation of intracorneal rings, and pockets for the implantation of corneal implants. The Z6 can also perform lamellar and penetrating keratoplasties or other treatments requiring lamellar resection of the cornea at varying depths. Ziemer Group announced at this year’s ASCRS meeting that the Z6 is also ready to be updated for use in cataract surgery. “We’ve been looking at what is necessary to properly perform clear corneal and astigmatism-managing incisions, capsulotomy and lens fragmentation and we plan to present a complete system,” Ziemer says.

He says the company is very pleased with the results of its femtosecond cataract surgery studies. “We have the most precise system on the market for refractive and other corneal surgeries, and that is our goal here as well. Our approach is very different from that of other femtosecond laser companies. While most others rely on rather high pulse energy and a low repetition rate, we use very low pulse energy and a high repetition rate, and our optics enable tiny, overlapping spots. This approach is extremely precise and good for tissue. For example, the lack of an inflammatory reaction on the cornea is clear immediately after surgery. We expect the same for our cataract surgery applications.”

Ziemer says that the way work flow is organized differs among ASCs, and is related to many factors, including what type of phaco machine and surgical microscope are used. Also, some ASCs and their surgeons prefer to place the femtosecond laser in the OR and others prefer it to be in a separate room. “The Femto LDV Z6 has by far the smallest footprint available, and it’s mobile, so surgery centers can place it wherever they like,” he says. “The laser’s articulating arm was designed for flexibility as well. It allows surgeons to place the laser to their right, their left or in front of them and work efficiently and comfortably.”

When Ziemer entered the ophthalmic business several years ago, he says, femtosecond lasers weren’t even a thought. “Now they’re really here and we can do very interesting things with them. We’re excited to see how we can take the technology even further in the future.”

An Opportunity Ready to be Seized

Femtosecond laser technology for cataract surgery is an opportunity for surgeon-owned ASCs to take a leadership position in their communities, and it can be a great surgeon recruitment and retention tool for corporate-owned and physician-group-owned facilities, LensAR’s Curtis says. “This is all about providing customized treatments for patients, becoming outcomes-based and lifestyle-based. Patients are attracted to it. Baby boomers in particular are familiar with lasers in all aspects of their lives — LASIK, dental, skin resurfacing — and they associate them with precision and helping doctors do a better job.” Curtis ended his comments with one caveat: “But first you have to make sure your patients understand that cataract surgery hasn’t always been performed with lasers.” ◊

References

1. Kránitz K, Takacs A, Miháltz K, et al. Femtosecond laser capsulotomy and manual continuous curvilinear capsulorrhexis parameters and their effects on intraocular lens centration. J Refract Surg. 2011;27(8):558-563.

2. Palanker DV, Blumenkranz MS, Andersen D, et al. Femtosecond laser-assisted cataract surgery with integrated optical coherence tomography. Sci Transl Med. 2010;2(58):58ra85.

3. Koch D, Batlle J, Feliz R, et al. The use of OCT-guided femtosecond laser to facilitate cataract nuclear disassembly and aspiration. Presented at XXVIII Congress of the European Society of Cataract and Refractive Surgeons; Sept. 5, 2010, Paris, France.

4. Steinert RF. Femtosecond Laser Refractive Cataract Surgery. 63rd Annual Proctor Lecture. Dec. 3, 2011. Accessed Aug. 29, 2012. Available from: http://www.ucsfcme.com/2012/slides/MOP12002/33SteinertFemtosecondLas erCataractSurgery.pdf.

5. Filkorn T, Kovács I, Takács A, et al. Comparison of IOL power calculation and refractive outcome after laser refractive cataract surgery with a femtosecond laser versus conventional phacoemulsification. J Refract Surg. 2012;28(8):540-544.

6. Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J. Refract. Surg. 2009;25(12):1053-1060.

7. Cionni RJ. Comparison of effective lens position and refractive outcome: femtosecond laser vs manual capsulotomy. Presentation at AAO/ISRS Refractive Surgery Subspecialty Day, Oct. 22, 2011, Orlando, Fla.

8. Reddy PK. Clinical study on safety and efficacy of femtosecond laser refractive cataract surgery. Paper presented at ASCRS annual meeting, April 22, 2012, Chicago, Ill.

9. Uy HS. Femtosecond laser lens fragmentation for higher grade cataracts. Presentation at AAO annual meeting 2010, Refractive Surgery Subspecialty Day, Oct. 15, 2010, Chicago, Ill.

10. Friedman NJ, Palanker DV, Schuele G. Femtosecond laser capsulotomy. J Cataract Refract Surg. 011;37:1189-1198.

11. Dick HB, Schultz T, Hengerer F, Conrad-Hengerer I. Experience with the Catalys Precision Laser System. Presentation at ISRS Symposium, Asia Pacific Academy of Ophthalmology Congress, April 2012, Busan, Korea.