Technology continues to improve, advance for femtosecond laser-assisted cataract surgery

The landscape of cataract surgery is evolving as a significant technology — femtosecond laser-assisted cataract surgery — quickly takes shape, studies unveil promising results and competition develops across the globe.

Femtosecond laser technology provides greater precision compared with manual techniques in cataract surgery and may be better for patients overall. It allows physicians to create a precise and centered capsulotomy for improved IOL placement and fragments the lens for less invasive removal.

However, with this evolving technology comes the challenges of U.S. Food and Drug Administration approval, competing technologies, availability, and cost to the practitioner and patient.

Ocular Surgery News spoke with several experts about femtosecond laser-assisted cataract surgery to provide an update on the technology and potential products in the pipeline.

Frank A. Bucci Jr., MD, founder and medical director of Bucci Laser Vision Institute, said that femtosecond laser-assisted cataract surgery is still in its infancy, particularly in the creation of clear corneal incisions for the correction of corneal astigmatism.

The precision and predictability of performing nuclear fragmentation and creating well-centered capsulotomies appears to be further developed compared with creating reliable and predictable corneal incisions for either entry wounds or for the correction of corneal astigmatism, according to Dr. Bucci. Difficulties with creating corneal incisions may be linked more to deficiencies in adequately visualizing the peripheral cornea than to the laser’s actual capacity for creating these incisions.

In the long run, femtosecond laser technology will be the driving force behind its acceptance, according to Frank A. Bucci, MD. Image: earlandsedor.com

While widespread adoption of the technology is likely to occur slowly and steadily over the next decade, he said, currently a wait-and-see approach may be appropriate.

“Although most of the questions around creating a favorable economic model to support the adoption of these lasers are largely unanswered, I believe that the technology is so compelling and offers so much to the patient and physicians that the technology itself will be the driving force behind creating solutions to these issues over the next 10 years,” Dr. Bucci said.

Research shows promise

New research has confirmed the idea that femtosecond laser-assisted technology will become the gold standard of cataract surgery because of its enhanced safety, accuracy and refractive outcomes, according to Mark Packer, MD, FACS, of Drs. Fine, Hoffman & Packer in Eugene, Ore.

“I have no question that, from a scientific and medical perspective, femtosecond cataract surgery offers more precise outcomes for refractive lens surgery,” Dr. Packer said. “This procedure offers greater accuracy and precision in capsulorrhexis construction, reduced ultrasound energy for nucleofractis and elegant intrastromal corneal incisions.”

Femtosecond lasers can assist in corneal incisions, lens fragmentation and capsulorrhexis design, Dr. Packer said.

The promise of this technology is a dramatic increase in the accuracy, safety and reproducibility of all the corneal and capsular incisions required to take out a cataract.

Mark Packer

“The femtosecond laser delivers consistent, clean and precise construction of a centered, round, custom-designed capsulorrhexis in any size of the surgeon’s choice. This capability alone provides adequate reason to adopt femtosecond surgery,” he said.

Recent studies have confirmed that the anterior capsulotomy can be made perfectly round, exactly sized and precisely positioned in the anterior capsule, according to William W. Culbertson, MD, the Lou Higgins Professor of Ophthalmology at Bascom Palmer Eye Institute. This, in turn, may lead to improved centration of the IOL and less variability in the range of effective lens position.

In addition, some hot topics have developed over the past year, including the ability to create intracorneal relaxing incisions to potentially treat astigmatism with arcuate relaxing incisions, as well as small amounts of residual myopia or hyperopia with either mini radial keratotomy or circumferential keratotomy. Dr. Culbertson believes that live topographically referenced corneal optical coherence tomography would be best used to make this incision.

“One area that has been met with mixed emotion is limbal relaxing incisions for the correction of keratometric astigmatism,” Dr. Bucci said. “This is due in part to common errors in measurement of surgically induced astigmatism and unavoidable inconsistencies in construction technique.”

There is still a large degree of uncertainty regarding how effective the laser approach is, and the novelty of the procedure may decrease efficiency in terms of patient flow in the operating room, at least until the surgical team becomes acclimated to how the technology works, Dr. Bucci said.

Dr. Packer said that femtosecond lasers may enable surgeons to minimize preoperative and surgically induced astigmatism.

[“This laser technology] offers the possibility of automated construction of topographically matched incisions and intraoperative enhancements, similar to those performed with standalone intraoperative aberrometry,” Dr. Packer said.

According to Dr. Culbertson, another area of recent research is the possibility of designing IOLs that are incorporated in the edge of the anterior capsule; that way, the lateral and anterior position of the IOL can be precisely determined by the position and size of the laser anterior capsulotomy.

“During the last year it has become apparent that immersion-based patient interfaces have advantages over fixed-curve contact plates for both imaging and laser treating the cornea and lens,” he said. “In addition, with immersion interfaces, there can be accurate imaging and compensation for lens tilt during laser treatment.”

Dr. Culbertson told OSN in 2010 that femtosecond laser-assisted cataract surgery will likely boost the prominence and value of cataract surgery as a refractive procedure. He continues to stand behind this notion and said that additional research has supported the value of the femtosecond laser to enhance the safety of the surgery and to refine refractive outcomes.

“This has led to expanding interest in this technology both by surgeons and patients,” he said.

First-generation laser

Historically, multiple steps of a cataract procedure have been performed manually with a blade. In October 2010, the LenSx laser system platform (Alcon), the first generation of femtosecond lasers for cataract surgery in the U.S., received FDA approval for commercial use. According to Stuart Raetzman, vice president of global marketing and U.S. area president for Alcon, LenSx has received FDA clearance for capsulotomy, lens fragmentation and all corneal incisions at the time of cataract surgery.

The LenSx laser is designed to provide a high-resolution image of the eye to drive precision guidance of the laser; create a perfectly sized, shaped and centered capsulotomy; effectively fragment the lens for removal by irrigation and aspiration or low-energy phacoemulsification; create all required corneal incisions with perfect dimension and architecture; and provide a refractive solution to pre-existing astigmatism by creating corneal incisions of precise shape and depth as programmed by the surgeon, according to Mr. Raetzman.

Stuart Raetzman

With this laser, surgeons can create custom, blade-free incisions that are more precise, thus eliminating some of the variables that have complicated cataract surgery even with modern techniques.

“Recent studies reported using the LenSx instrument have demonstrated that all the laser-created incisions seal tightly without hydration, indicating a better construction than can be achieved employing a manual blade technique,” Dr. Culbertson said. “This would be expected to result in a tighter incision with less chance of postoperative leaking and consequent endophthalmitis.”

The LenSx laser officially launched at the 2011 American Society of Cataract and Refractive Surgery meeting.

“The next era of innovation is now in motion — an era that will lead to further advancements in technology and techniques that surgeons can use for the benefit of their patients,” Mr. Raetzman said. “The LenSx laser is now commercialized globally and used daily by more than 100 surgeons.”

According to OSN Refractive Surgery Board Member Stephen G. Slade, MD, there are more than 20 LenSx blade-free femtosecond cataract laser units today being operated in the United States, with a handful being operated internationally. Thousands of procedures have been done in the United States.

“This laser has become the subject of much discussion between people who favor the technology and those with questions, which is terrific because questions help guide our understanding of this technology,” he said. “We need good scientific queries.”

New questions have arisen: Can capsulotomies be centered? Will femtosecond laser surgery work with all lenses? What about different types of cataracts? How will it treat astigmatism?

“The questions are flowing in, and we have the evidence to answer them and show the benefits for all eyes, hard nuclei, soft nuclei and the difficult cases as well,” Dr. Slade said.

Platforms in the pipeline

Other laser platforms are being developed to meet the advancing needs of refractive cataract surgeons and their patients.

LensAR, a developer of next-generation laser technology for refractive cataract surgery, received 510(k) clearance from the FDA in March 2011 for use of the LensAR laser system for anterior capsulotomy and lens fragmentation during cataract surgery.

The LensAR laser system is unique in that it uses a proprietary imaging system referred to as 3D-Confocal Structured Illumination (3D-CSI), meaning the laser and optical system are in the same pathway, allowing for more accurate beam placement and less error, according to Nick Curtis, chief commercial officer at LensAR.

“Unlike traditional imaging systems, 3D-CSI provides clean, high-signal, low-noise images that are both high-contrast and high-resolution, which allows the system to locate, identify, measure and provide automated, precise biometric measurements from the anterior surface of the cornea to the posterior surface of the lens capsule,” Mr. Curtis said.

From these images, the LensAR system then uses wave-tracing to create a 3-D model of the eye and includes the automated treatment patterns for the incisions, capsulotomy and lens fragmentation.

“The precision of this system also measure lens tilt and then automatically adjusts the treatment pattern for the capsulotomy and fragmentation to improve the safety and efficiency of the procedure and, at the same time, gives the surgeon the choice of capsulotomy placement in the optical axis, center of the pupil or cornea. The system is also highly efficient in reducing the ultrasound energy required to remove all grades of cataracts,” Mr. Curtis said.

“This is the first major advancement in cataract surgery technology that takes the precision associated with lasers and automates the manual aspects of the procedure to improve predicted outcomes. The LensAR laser system is complementary to many IOL technologies and will help lead to innovation in advanced intraocular lens design,” he said. “This technology is driving toward assisting surgeons to give patients their best options to achieve the vision they want based on their lifestyles, more LASIK-like results, more predictability and better outcomes in their cataract surgery.”

The LensAR system has been used in more than 500 eyes outside the U.S., but the company is making some upgrades to the commercial system that will require additional 510(k) submission. Clinical trials have been performed in Mexico City and in the Philippines, and one unit is planned for installation in Lima, Peru.

“Reports for capsulotomy and fragmentation demonstrated effectiveness across all grades of cataract, and this laser uses structured illumination and appears promising,” Dr. Packer said.

The LensAR laser will most likely be used for refractive cataract procedures with astigmatism management and advanced technology IOLs, according to Mr. Curtis.

OptiMedica also has a promising femtosecond laser in development: the Catalys Precision Laser System.

Catalys combines an integrated spectral domain OCT system with automated 3-D treatment customization, a novel patient interface design and a femtosecond laser engine optimized for laser cataract surgery applications, according to Mark J. Forchette, president and CEO of OptiMedica.

Mark J. Forchette

Its Liquid Optics interface provides for a fluid-filled patient interface that has shown, when compared with an initial curved applanation interface, a fivefold reduction in IOL pressure rise in porcine testing, less eye redness after the procedure, clearer resolution of OCT imaging and more precise laser delivery by eliminating the formation of corneal folds, he said. The Integral Guidance system of Catalys combines the long-range spectral domain OCT and 3-D treatment customization to accurately map the relevant ocular surfaces in 3-D and automatically customize the treatment plan based on physician-confirmed imaged anatomy and safety zone margins. Because the system registers surfaces and customizes treatment in 3-D, ocular tilt induced by docking is not an issue.

“The Catalys system was developed to offer physicians custom control of capsulotomy size, shape and centration, and precise lens fragmentation, including segmentation and softening. Future applications include laser incisions in the cornea delivered with unparalleled accuracy to address astigmatism and meticulously constructed multiplane cataract incisions,” Mr. Forchette said. “Clinical studies have shown that Catalys has the ability to deliver marked improvement over manual technique across a number of key measures, and we believe this superior performance will lead to superior outcomes.”

One unit is onsite in the Dominican Republic’s investigation site. OptiMedica received CE mark approval for Catalys in September to deliver capsulotomy and lens fragmentation, with CE mark approval for corneal incisions expected soon. The company is working toward 510(k) clearance from the FDA, and it expects to launch Catalys worldwide by the end of the year.

“This is the foundation of an entirely new area of surgical innovation,” Mr. Forchette said. “Cataract procedures are clearly in the midst of a revolutionary change, and with Catalys, we expect to provide leading technology that satisfies the high expectations of surgeons and their patients.

Other players

In March, Bausch + Lomb and Technolas Perfect Vision announced an agreement to globally distribute the first femtosecond laser capable of performing both cataract and refractive procedures on one platform. It does not yet have 510(k) clearance from the FDA, but two units are operating in India and Germany. The platform, called VICTUS, was introduced at the European Society of Cataract and Refractive Surgeons meeting in September 2011.

Under the arrangement, Technolas will develop and manufacture the system and service the product through its current worldwide service organization. Bausch + Lomb Surgical will leverage its cataract expertise and commercial capabilities to globally distribute the femtosecond laser.

“This laser has the capability to perform corneal refractive procedures,” Dr. Packer said.

Another player in this field is the iFS laser (Abbott Medical Optics), a fifth-generation IntraLase laser that, to date, has demonstrated capability for corneal surgery and may be adapted to lens surgery, according to Dr. Packer. The iFS has some unique capabilities applicable to LASIK but also to other types of eye surgery. It potentially allows for more precise incisions and “lock-tight” or “zipper” closures, which result in more secure wounds and better results.

“This could represent an attractive option for surgeons who already own this laser,” Dr. Packer said.

Research in Peru

There are a limited number of centers where companies are conducting research, and the technology is not yet being offered commercially worldwide, according to Dr. Bucci, who has undertaken an effort to combat third-world blindness with a LensAR platform. This project will provide much needed free surgery for some of the poor, blind people located in Peru and at the same time produce much sought-after results from investigational trials that can assist in moving this technology forward.

“I am extremely excited to have the opportunity to use this technology at our center in Peru and contribute to a foundation of medical research while simultaneously fulfilling our mission statement of four words: make blind people see,” he said.

The center has been open for 3 years, and to date more than 4,000 cataract surgeries have been performed there. Dr. Bucci and colleagues plan to continue studies to evaluate the safety, predictability and reliability of the laser as it relates to enhancing patient lifestyle.

“Everyone wants to know how fast this new technology will become mainstream, what is the perception of value by the surgeons and patients, and what will they be willing to pay for access to this technology,” he said.

Cost impact

With advancing femtosecond surgery technologies lies a question in the minds of cataract surgeons: “How can I afford it?”

“The economic model remains a tough nut to crack, particularly for surgeons who do only a limited number of refractive IOL cases,” Dr. Packer said. “The saving grace, given the current restrictions of Medicare, remains the correction of astigmatism and presbyopia. Our ability, since 2005, to charge a reasonable fee for services associated with presbyopia-correcting IOLs has facilitated great outcomes for our patients in terms of enhanced quality of life, increased revenue for our practices and increased investment in new technology. Without the premium channel, innovation in cataract surgery would languish.”

Most company officials said the lasers will most likely be private pay, with a capital expense as well as procedure fees associated with the use of the technology. For patients with private health insurance, femtosecond laser-assisted cataract surgery will likely be offered as a premium service.

Others said it is still too early to anticipate the potential cost and whether Medicare billing for femtosecond laser-based services will be allocated. However, history has shown that patients are willing to pay for premium technology that delivers superior outcomes.

“The cost impact will best be determined by analyzing the impact on patient care from beginning to end,” Mr. Raetzman said. “With refractive cataract patients, that not only includes upfront costs of items such as diagnosis and counseling, but also follow-up care after surgery.”

Future of femtosecond surgery

Despite current roadblocks of availability and cost impediment, Dr. Culbertson believes this technology will steadily establish its worthiness as more surgeons use it because techniques will be refined and improved.

“Femtosecond laser-assisted cataract surgery is a novel technology that represents the most promising improvement in cataract surgery since the advent of phacoemulsification and foldable IOLs,” he said.

Stephen G. Slade

Dr. Slade said the proof of femtosecond surgery’s success is in the physician and patient experiences, as well as research. Last year, Dr. Slade told OSN that he was optimistic about the safety and efficacy of femtosecond laser-assisted cataract procedures; given new research to date, he believes that to be more true than ever.

“The hypothesis was that this would provide more precision and add safety to the procedure,” Dr. Slade said. “I have not seen anything to the contrary, no evidence against this.”

In fact, the evidence continually builds regarding the efficacy of the procedure, Dr. Slade said. Safety is harder to prove because thousands of cases are needed, but information presented and published about the accuracy and circularity of the capsulotomy, the centration of the lens and the refractive results of astigmatic correction show benefit.

“I think this will be the standard way people have cataracts removed in the future, as it becomes more and more available,” he said. “In my opinion, looking at the evidence, femtosecond surgery provides better results, even in infancy.”

“The future of femtosecond laser surgery for cataracts is very bright,” Dr. Slade said. “I highly suggest my colleagues keep up with this field and make up your own opinion about this new technology based on the science.” – by Tara Grassia

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References:

• Bausch + Lomb. Bausch + Lomb and Technolas Perfect Vision announce agreement in principle to distribute the first femtosecond laser capable of performing both cataract and refractive surgery on one platform. http://www.bausch.com/en/Our-Company/Recent-News/2011-Archive/technolas-perfect-vision.
• Friedman NJ, Palanker DV, Schuele G, et al. Femtosecond laser capsulotomy. J Cataract Refract Surg. 2011;37(7):1189-1198.

• Frank A. Bucci Jr., MD, can be reached at Bucci Laser Vision Institute, 158 Wilkes-Barre Township Blvd., Wilkes Barre, PA 18702; 570-825-5949; email: buccivision@aol.com.
• William W. Culbertson, MD, can be reached at Bascom Palmer Eye Institute, P.O. Box 016880, Miami, FL 33101; 305-326-6364; email: w.culbertson@miami.edu.
• Nick Curtis can be reached at LensAR, 2800 Discovery Drive, Orlando, FL 32826; 407-499-4331; email: nick.curtis@lensar.com.
• Mark Forchette can be reached at OptiMedica, 3130 Coronado Drive, Santa Clara, CA 95054; 888-850-1230; email: mforchette@optimedica.com.
• Mark Packer, MD, FACS, can be reached at Drs. Fine, Hoffman & Packer, LLC, 1550 Oak St., Suite 5, Eugene, OR 97401; 541-687-2110; email: mpacker@finemd.com.
• Stuart Raetzman can be reached at Alcon, 6201 South Freeway, Fort Worth, TX 76134; 817-615-5092; email: stuart.raetzman@alconlabs.com.
• Stephen G. Slade, MD, can be reached at Slade & Baker Vision Center, 3900 Essex Lane, Suite 101, Houston, TX 77027; 713-626-5544; email: sgs@visiontexas.com.
• Disclosures: Dr. Bucci is a consultant for LensAR. Dr. Culbertson is a consultant for OptiMedica. Mr. Curtis is chief commercial officer at LensAR. Mr. Forchette is president and CEO of OptiMedica. Dr. Packer is a consultant for Abbott Medical Optics and has equity in Advanced Vision Science, Bausch + Lomb Surgical, Corinthian Ophthalmic, GE Healthcare, Ista Pharmaceuticals, LensAR, mTuitive, NewSee, Rayner Intraocular Lenses, Surgiview, Transcend Medical, TrueVision Systems and WaveTec Vision Systems. Mr. Raetzman is area president, US and vice president of Global Marketing for Alcon. Dr. Slade is a consultant for Technolas Perfect Vision and Alcon, and is the medical director for LenSx.