Issue: March 2012
April 11, 2012
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Femtosecond laser assisted surgery could revolutionize cataract removal in Europe

Issue: March 2012
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After conquering the areas of refractive surgery and corneal grafting, the femtosecond laser has entered the realm of cataract surgery. It holds the promise of creating a second revolution in cataract surgery, following the first revolution of Kelman’s phacoemulsification.

Zoltan Z. Nagy, MD, said phaco has gradually improved over the years, particularly in regard to incision size, but no major changes have been introduced.

“The femtosecond laser technology has brought new thoughts and methods in cataract surgery, and this is what we call a revolution,” he said.

Dr. Nagy was the first surgeon in the world to perform femtosecond laser-assisted cataract surgery, which occurred at the University Hospital of Budapest, Hungary, in August 2008. He was involved in the research and development team of the LenSx laser (Alcon) and has so far performed about 700 femtosecond-guided cataract procedures.

Zoltan Z. Nagy, MD, the first physician to perform femtosecond laser-assisted cataract surgery, said it provides significant advantages for performing the capsulorrhexis.
Zoltan Z. Nagy, MD, the first physician to perform femtosecond laser-assisted cataract surgery, said it provides significant advantages for performing the capsulorrhexis.
Image: Nagy ZZ

“I have seen the laser progress from the first prototype to the current technology. Within the various studies we’ve done with the laser, I have included about 30% to 40% of my cataract patients here, and I am still quite busy, with people coming from all over Europe, the U.S., Australia and South America,” he said.

Growing awareness, cost issues

Awareness of the availability and superior results of this new method of cataract surgery has rapidly increased. A survey of European surgeons in 2 consecutive years showed that in 2010, only 50% of ophthalmologists in the region were aware of the technique, while in 2011, the number had grown to 90%. More than half of surgeons surveyed said they had plans to adopt the new technology within 5 years. A total of 65% perceived the high cost as a limitation, however.

Internet-savvy patients have quickly become informed of the advantages of this technique and ask for it wherever femtosecond lasers are available.

“On my website, I published the news that I have the femtosecond for cataract surgery, and 3 days later, patients started asking to be operated with femtosecond,” Lucio Buratto, MD, OSN Europe Edition Associate Editor, said.

Patients generally tend to trust laser surgery more, he said, as it is perceived as less traumatic, painless, safer and more precise, in addition to having a faster recovery.

Dr. Buratto, director of a large private practice in Milan, was the second ophthalmologist in Europe to acquire a LenSx system and has so far treated about 60 cases. He has been using it since September 2011.

Cost, however, is an issue. Femtosecond laser-assisted cataract surgery is an expensive technique, and to date, no reimbursement scheme is provided by either national health systems or private insurances.

“At the Vissum Corporation Institute in Alicante, [Spain], we’ve had the laser since October 2011 and are very eager to use it as much as possible,” Jorge L. Alió, MD, PhD, OSN Europe Edition Editorial Board Member, said. “If we have limited it to 10% to 15% of our cases, it is not because of indications, but because there is no financial model for this surgery. Insurances are still reluctant to invest in this technology, and only a minority of patients can afford to pay for femto out of their own pocket.”

Laser systems

There are currently four companies involved in the development of femtosecond laser technology for cataract surgery: Alcon, LensAR/Topcon, OptiMedica and Technolas Perfect Vision/Bausch + Lomb.

“Each one of these lasers has developed unique features to be competitive on the market,” Joseph Colin, MD, OSN Europe Edition Editorial Board Member, said. “LenSx and OptiMedica have integrated real-time OCT, providing complete visualization of the anterior segment during each phase of the procedure. The LensAR laser uses Scheimpflug imaging to register the ocular structures prior to laser activation. The LensAR and OptiMedica have a liquid optic interface that creates no pressure on the eye and provides comfortable docking and accurate acquisition of data for the imaging systems and laser. The Technolas laser is the first multitask platform that can be used for LASIK flap creation, cataract and therapeutic procedures.”

Dr. Colin and his colleagues at Bordeaux University Hospital, France, have been interested in the potential application in cataract surgery from the early years of femtosecond laser use and have developed their own laboratory prototype for research.

“We have not been able to acquire a proper femtosecond laser yet,” Dr. Colin said. “There are currently two of them in France, which were delivered in December last year to private practices.”

As a university hospital, Bordeaux might be able to receive a public grant for the laser within a research project involving five centers in France. The aim of that study is to compare the clinical and economic impact of femtosecond laser with traditional phaco to evaluate, scientifically and economically, the results of switching to femtosecond laser-assisted surgery.

Advantages

The steps of cataract surgery that can be performed with the femtosecond laser are nucleus liquefaction/fragmentation, capsulorrhexis, corneal incision and, when needed, astigmatic relaxing incisions.

“We have been able to evaluate, in a large cohort of patients with a long follow-up, that there are significant advantages in performing the capsulorrhexis with femtosecond laser,” Dr. Nagy said. “We can guarantee the size and position of the rhexis and a perfect circumferential rhexis-optic overlap. This leads to perfect centration of the intraocular lens, leading to better visual quality, fewer or no problems with night vision, diplopia, myopic or hyperopic shift.”

Centration is particularly critical with premium implants, which can reach their full potential only when placed in a perfect anatomic position.

“It is definitely the option to offer to younger people who come for presbyopia. They want a premium lens and guaranteed results, and we can give this to them with femtosecond surgery,” Dr. Nagy said.

Higher predictability and reproducibility of both the rhexis and corneal incision steps are key features in favor of femtosecond laser procedures, according to Dr. Alió, especially in multi-surgeon practices.

“Outcomes will be more regular and comparable,” he said.

He also expects better outcomes with multifocal IOLs and other premium lenses.

Pre-chopping the lens with the laser allows the surgeon to use less ultrasound. Dr. Nagy found that 42% less phaco energy and 51% less phaco time are used.

“In practical terms, it means that the aqueous temperature rise is less, leaving us with healthier endothelial cells after surgery,” he said.

Less ultrasound energy might also lead to a decreased rate of cystoid macular edema (CME), as demonstrated by Dr. Nagy in two studies.

“We need to extend these studies to more eyes, but it is likely that the less inflammatory mediator release and less mechanical trauma may lead to a decreased incidence of CME,” he said.

The surgeon can better predict the size and geometry of the corneal wound and make it uniplanar, biplanar, triplanar or multiplanar. Dr. Nagy performs biplanar incisions, which are self-sealing and carry no risk of infection.

“This allows me to pre-treat at least four patients outside the OR and then send them in turn to have phaco. At the end of surgery, because you have a very nice structured wound, you need no hydration,” he explained.

As for arcuate keratometry, the inbuilt OCT system allows the visualization and creation of a controlled corneal incision.

“Safety and refractive predictability are greatly increased,” Dr. Nagy said.

Restructuring surgical practices

Introducing the femtosecond laser in cataract surgery might require a new organization of patient flow, work space, clinic staff and appointment times. The best ways to make the new structure work efficiently are still a matter of debate.

“Typically, in most surgical centers worldwide, the new laser is kept outside the OR, but both the laser and phaco stages are performed by one surgeon. Other more efficient solutions, like having specialized non-medical personnel do the femtosecond stages, might be possible in the future,” Dr. Colin said.

At the University Hospital of Budapest, the femtosecond laser has been installed in a dedicated room, Dr. Nagy said.

“We had so many times the technicians around to study, service and upgrade the laser over these years that it was definitely not feasible to have it in the operating room. Also, the operating room is used by many other surgeons, and we don’t want to make it too crowded,” he said.

He is personally involved in all stages of the procedure, he said.

Dr. Alió has placed the LenSx laser in the laser operating theater, together with the excimer laser and the IntraLase femtosecond laser (AMO).

Jorge L. Alió, MD, PhD
Jorge L. Alió

“This room has specific temperature and humidity for lasers and the same standards of sterility as the OR,” he said. “Here the patient undergoes the femtosecond phase of the procedure and is then moved to the OR, as we do for femto-LASIK.”

Although the femtosecond procedure may currently appear to be more time-consuming than traditional phaco, it is easy to imagine that it may become highly efficient, time-sparing and cost-effective, with one laser feeding several operating rooms in a high-volume ambulatory surgery center, Dr. Buratto said.

“A specific surgeon performs all of the laser treatments, and other surgeons complete the operation with phaco and lens insertion inside the ORs,” he said.

Dr. Nagy foresees a system in which a few large ASCs will acquire the laser. Groups of surgeons will share the cost and the use of the laser and treat their patients there, rather than have individual lasers in small practices.

Integration potential

Costs might drop with more efficient organization in the clinic, and the technology itself could become less expensive as the market expands, but most surgeons agree that femtosecond laser-assisted cataract surgery is likely to continue to be more expensive than phaco.

Some questions have yet to be answered. In Europe, where most countries’ health care systems are based on universal health care, what will be the governments’ share of the total cost of the new procedure? Are European health care systems ready to invest in femtosecond laser-assisted cataract surgery?

According to Dr. Buratto, as with other procedures, approaches could differ considerably from country to country. If full coverage is unlikely to be granted in the current economic downturn, the technique might be more easily integrated by the national health systems of countries that have started to accept forms of co-payment, including the Netherlands and France. In other countries, such as Switzerland, Germany and Spain, insurance companies that offer coverage for premium procedures to customers who can pay might extend their offer to femtosecond laser-assisted cataract surgery once clinical evidence widens.

“In other countries, like the U.K., Italy and Russia, where co-payment is refused for fear of creating an unequal coverage system, femtosecond laser cataract surgery is likely to remain fully private for the time being,” Dr. Buratto said.

Lucio Buratto, MD
Lucio Buratto

In Scandinavian countries, large university hospitals could adopt the procedure to keep their status as institutions that deliver advanced treatments.

“These institutions have special funding to introduce new technologies to keep their status of research and investigation centers. [Even though] the business model would cause more loss than profits, due to their large volume practice, they are allowed to investigate on new technologies as long as they make profits on other traditional treatments,” Dr. Buratto said.

In the longer time frame, however, as the procedure becomes a standard of care, penetration within the public reimbursement system is likely to occur as a natural process, similar to the transition from extracapsular cataract extraction to phaco.

“Twenty-five years ago, we were doing very neat and well-done ECCE, and someone came up with phaco,” Dr. Alió said. “It was more expensive, more cumbersome and time-consuming. We needed to be trained and to buy new, expensive equipment. There was hot discussion on the pros and cons. And now everyone is doing phaco.”

He said that the current transition involves much higher costs and that health care systems will be required to make a much larger investment.

“We need strong clinical evidence that patients, or at least some patients, could benefit significantly more from this technology compared to phaco,” Dr. Buratto said. “We also need to reduce the procedure time and cost.”

In Europe, public reimbursement of new technologies and techniques, he explained, is granted through a process called Health Technology Assessment, in which assessors are public health institutions.

“Following clinical evidence, provided by the companies involved, of the superiority of the proposed technology or technique vs. the current standard, a health economic analysis is performed to verify cost-effectiveness, quantify and make decisions about coverage,” Dr. Buratto said.

In countries where universal health care has been implemented, the citizens themselves will most likely put pressure on governments to provide this service as part of the national health care program.

Although convinced that femtosecond technology is a step forward in cataract surgery, Dr. Colin cautioned the ophthalmic community from the danger of “running too fast for fear of missing the train.”

“The risk is that of making huge investments in the technology because we are worried about the competition rather than because we are truly convinced of the advantages of the laser,” he said.

“If these advantages are real and worth investing in, if the transition from phaco to femto is the step we should make, only further studies can show. We should wait for these results and not precipitate decisions,” Dr. Colin said. – by Michela Cimberle

References:

Buratto L, Global Market Intelligence, Alcon Inc. A 45 minute online questionnaire to cataract surgeons in France, Germany, Italy and Spain. 2010-2011.

Chatoux O, Touboul D, Buestel C, Balcou P, Colin J. Crystalline lens photodisruption using femtosecond laser: experimental study. J Fr Ophtalmol. 2010;33(7):472-480.

Ecsedy M, Miháltz K, Kovács I, Takács A, Filkorn T, Nagy ZZ. Effect of femtosecond laser cataract surgery on the macula. J Refract Surg. 2011;27(10):717-722.

Friedman NJ, Palanker DV, Schuele G, et al. Femtosecond laser capsulotomy. J Cataract Refract Surg. 2011;37(7):1189-1198.

He L, Sheehy K, Culbertson W. Femtosecond laser-assisted cataract surgery. Curr Opin Ophthalmol. 2011;22(1):43-52.

Kránitz K, Takacs A, Miháltz K, Kovács I, Knorz MC, Nagy ZZ. Femtosecond laser capsulotomy and manual continuous curvilinear capsulorrhexis parameters and their effects on intraocular lens centration. J Refract Surg. 2011;27(8):558-563.

Mamalis N. Femtosecond laser: the future of cataract surgery? J Cataract Refract Surg. 2011;37(7):1177-1178.

Masket S, Sarayba M, Ignacio T, Fram N. Femtosecond laser-assisted cataract incisions: architectural stability and reproducibility. J Cataract Refract Surg. 2010;36(6):1048-1049.

Miháltz K, Knorz MC, Alió JL, et al. Internal aberrations and optical quality after femtosecond laser anterior capsulotomy in cataract surgery. J Refract Surg. 2011;27(10):711-716.

Moshirfar M, Churgin DS, Hsu M. Femtosecond laser-assisted cataract surgery: a current review. Middle East Afr J Ophthalmol. 2011;18(4):285-291.

Nagy ZZ, Kránitz K, Takacs AI, Miháltz K, Kovács I, Knorz MC. Comparison of intraocular lens decentration parameters after femtosecond and manual capsulotomies. J Refract Surg. 2011;27(8):564-569.

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.

Naranjo-Tackman R. How a femtosecond laser increases safety and precision in cataract surgery? Curr Opin Ophthalmol. 2011;22(1):53-57.

Palanker DV, Blumenkranz MS, Andersen D, et al. Femtosecond laser-assisted cataract surgery with integrated optical coherence tomography. Sci Transl Med. 2010;2(58):58-85.

Roberts TV, Sutton G, Lawless MA, Jindal-Bali S, Hodge C. Capsular block syndrome associated with femtosecond laser-assisted cataract surgery. J Cataract Refract Surg. 2011;37(11):2068-2070.

Uy HS, Edwards K, Curtis N. Femtosecond phacoemulsification: the business and the medicine. Curr Opin Ophthalmol. 2012;23(1):33-39.

For more information:

Jorge L. Alió, MD, PhD, can be reached at Vissum Corporation, Avenida de Denia, s/n, 03016 Alicante, Spain; +34-965150025; fax: +34-965151501; email: jlalio@vissum.com.

Lucio Buratto, MD, can be reached at Centro Ambrosiano di Microchirurgia Oculare (CAMO), Piazza Repubblica 21, 20124 Milan, Italy; +39-02-6361191; fax: +39-02-6598875; email: office@buratto.com.

Joseph Colin, MD, can be reached at Hôpital Pellegrin, Place Amélie Raba-Lèon, 33076 Bordeaux, France; +33-5-56795608; fax: +33-5-56795909; email: joseph.colin@chu-bordeaux.fr.

Zoltan Z. Nagy, MD, can be reached at Semmelweis University, Maria u. 39, H-1085 Budapest, Hungary; +36-20-815-8468; email: nagy.zoltan_zsolt@med.semmelweis-univ.hu or zoltan.nagy100@gmail.com.

Disclosures: Dr. Alió is clinical investigator for Alcon LenSx and is on the board of directors of Alcon LenSx, but has no financial interests. Dr. Buratto and Dr. Colin have no relevant financial disclosures. Dr. Nagy is a consultant for Alcon LenSx.

 

POINTCOUNTER

Do you think femtosecond lasers will eventually make phacoemulsification an obsolete technique?

POINT

Potential of femtosecond laser similar to potential phaco had over ECCE

Michael C. Knorz, MD
Michael C. Knorz

The femtosecond laser performs all the critical steps of cataract surgery with incredible ease and high precision: capsulorrhexis, fragmentation or liquefaction of the nucleus, corneal incisions and astigmatism correction. In my opinion, increased refractive predictability is one of the key advantages of the new method. The capsulorrhexis is more reproducible, resulting in a higher rate of anterior capsule/IOL optic overlap, which is one of the prerequisites of a stable IOL position. A stable IOL position should cause less variability in effective lens position, which is the axial position inside the eye that the IOL finally ends up with after capsular fibrosis. The laser capsulorrhexis therefore leads to better IOL centration, less IOL tilt and fewer higher-order aberrations.

Another aspect of improved refractive outcomes is the option to perform corneal incisions to correct astigmatism. The reproducible incision length and arc shape should greatly improve outcome predictability.

As I believe in its superior results, I offer laser refractive lens surgery as my standard. I typically will not offer a choice to the patient, just as I do not offer a choice of microkeratome LASIK or femto-LASIK; I simply use femto-LASIK. My initial experience with this approach is quite good, and patients have readily embraced the new technology.

I believe the potential of laser refractive lens surgery is similar to the potential phaco had over ECCE. Lens surgery will change in the next few years. Our refractive results have to improve considerably over what is standard of care in cataract surgery today. The femtosecond laser will make the procedure more expensive, but price has never been a limiting factor if the outcomes are better. I believe we are at the beginning of a new era that will be remembered much like the transition from ECCE to phaco.

Michael C. Knorz, MD, is an OSN Europe Edition Editorial Board Member. Disclosure: Dr. Knorz is a consultant to Alcon.

 

COUNTER

Intrinsic limitations to femtosecond laser will not be overcome

Alessandro Galan, MD
Alessandro Galan

The transition from ECCE to phaco, from removal of the whole lens to fragmentation and aspiration of the lens nucleus, was indeed a revolution. No revolutionary concepts have been introduced by the femtosecond laser in cataract surgery, just a new technology. The laser performs some of the maneuvers that the surgeon routinely performs. It is a complementary technique, not an alternative, because phaco is still necessary.

The capsulorrhexis is well-centered but not continuous. The femtosecond laser does not produce a continuous cut, but a row of micro-explosions. It is a revisited, more refined can-opener technique, which cannot achieve the same resistance to tear as a continuous rhexis performed manually with a needle or forceps.

When I perform the incision manually, I have an immediate feeling of the length, depth and angle that is best for each eye. The decision-making process is one with the surgical maneuver. Femtosecond laser incisions take into account that all eyes are different, but they require a time-consuming preoperative evaluation of the eye and setting of the laser.

Last but not least, the laser beam needs a transparent target, and nucleus fragmentation can therefore be performed with cataracts that are hardly worth operating on. With most old age cataracts, the laser will not work at this stage. With complicated cataract cases, your surgical ability and your old phaco machine will help, not the laser.

In other words, in simple cataract cases, the laser does nothing more than the surgeon can do and does it in at least double the time with cumbersome changes of rooms, beds and patient positions. In complicated cataract cases, or simply with denser cataracts, the laser is not an option. There are limitations that are intrinsic to the femtosecond laser and will not be overcome, no matter how much the technique evolves.

Alessandro Galan, MD, is an OSN Europe Edition Editorial Board Member. Disclosure: Dr. Galan has no relevant financial disclosures.