This article was originally printed in Ophthalmology Management in the August 2014 issue. View the article with images here.
Focus on Cataract Surgery
The femtosecond laser platform: what’s next
Here’s a look at where this technology is headed and where it came from.
BY KENDALL E. DONALDSON, MD, MS
Cataract procedures used to be so simple. When a patient presented with a cataract, we scheduled surgery with no additional discussion. Then came premium IOLs in 2003 and our chair time increased as we found ourselves elaborating on the various lens options available. But, with the introduction of femtosecond lasers to our cataract surgery armamentarium, the world of phacoemulsification changed forever.
This additional level of complexity requires that both the surgeon and patient make key decisions. Cataract surgery options have now expanded to the point at which a busy phacoemulsification surgeon could truly benefit from a full-time staff member dedicated to discussing the options available to customize each patient’s treatment plan. As options have grown, so have patient expectations. Here we review the four brands of femtosecond lasers on the market in the United States and their individual capabilities. We’ll also peek into what they have in store for the future.
Alcon (Fort Worth, Texas) entered the refractive cataract arena in earnest with its 2010 acquisition of the LenSx laser. (The company already had some experience with excimer lasers for LASIK with the Nidek Summit Laser and the LADARVision platforms.) LenSx was developed by the same engineering staff (under the direction of Ronald Kurtz) that brought us Intralase (Abbott Medical Optics, Santa Ana, Calif.). This acquisition positioned Alcon to be a leader in the ground-breaking field of femtosecond cataract surgery.
Over the past four years, we have experienced dramatic advances in LenSx technology with several software upgrades allowing the laser to function more efficiently with improved imaging capabilities and ease of use. We have also benefitted from the evolution of a hard contact lens applanating patient interface to the current SoftFit technology reducing corneal folds, thus improving continuity of laser application to the ocular structures.
We are anticipating the release of new laser fragmentation patterns from LenSx that will allow us to perform more segmented lens fragmentation. Similar to other lens platforms, a 350-μm grid pattern will soon allow ophthalmologists to fragment the nucleus into smaller segments and possibly further reduce ultrasound energy expenditure during phacoemulsification. Alcon is also working on several modalities designed to increase efficiency and reduce both total time under suction and treatment time.
Alcon has been preparing for the launch of its Verion integrated cataract suite for some time now. It is currently being released throughout the United States in a staged approach. Several clinical sites around the country are already benefiting from this technology. It allows the surgeon to better integrate the preoperative tools for planning and assessment into a template to be used real-time during the surgical procedure. This will further improve accuracy of lens centration and toric placement during cataract surgery with an ultimate goal of approaching a patient’s best visual potential (similar to LASIK outcomes for younger patients). The Verion system will also serve as a tool postoperatively for outcomes analysis and self-optimization of results.
Surgeons are anticipating new laser fragmentation patterns from the LenSx laser system.
Alcon currently has approximately 300 lasers in use within the United States, with more than 650 units worldwide. The LenSx laser is also available as a mobile unit through Sightpath, a company that provides both the laser as well as the technical support on the surgical day.
Several femtosecond lasers were initially derived from femtosecond LASIK surgery (such as LenSx and VICTUS), whereas others were developed primarily for cataract surgery (such as Catalys and LensAR).
The predecessor to the VICTUS femtosecond laser (Bausch + Lomb, Bridgewater, N.J.) was originally introduced in 2004 when it received 510(k) clearance and CE Mark for LASIK flap creation. It was developed in a joint venture between Bausch + Lomb and Technolas Perfect Vision. Bausch + Lomb has since exercised its option to purchase all outstanding shares of Technolas Perfect Vision.
The VICTUS laser was used to create the first intracorneal tunnels for ring segments to treat keratoconus.
In 2005, this platform was used to create the first intracorneal tunnels for ring segments to treat keratoconus. That same year, it was used to perform astigmatic keratotomy incisions and the first penetrating keratoplasty with a femtosecond laser.
In 2012, the VICTUS laser was cleared in the United States for the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and anterior capsulotomy during cataract surgery. In 2013, VICTUS received 510(k) clearance for the creation of penetrating arcuate corneal incisions.
The VICTUS patient interface has also evolved over the past two years, with a wider central internal aperture (from 9.5-mm to 12.0-mm treatment area) with a stable external diameter of 21 mm, improving imaging capabilities while maintaining consistent ease of docking. Its software has continued to evolve to improve ease of use.
The VICTUS femtosecond laser is currently available for sale in 58 countries with installations in 25 countries. More than 20,000 procedures have been performed. The VICTUS offers dual modality performance for both cataract and LASIK surgery. It has both a liquid interface, for cataract procedures, and a curved interface with regular docking, for corneal procedures. The interface shifts from the liquid layer in cataract procedures to full contact docking for corneal procedures. The versatility of the VICTUS laser makes it attractive for a cataract and refractive surgeon with an interest in performing LASIK, cataract surgery, penetrating keratoplasty and corneal ring segments.
Bausch + Lomb announced last month it received 510(k) FDA clearance for femtosecond-assisted lens fragmentation. In addition, the company is planning an upcoming software upgrade which should simplify the physician interface and facilitate ease of use.
B+L recently partnered with Cirle (Miami) to create an image-guided navigation system that will project a template through the operating microscope in order to guide the surgeon through the surgical procedure.
Mark Blumenkranz, MD, and a group of scientists from Coherent Laser founded a company called Optimedica in 2004.
Competitors on the horizon
Although the LensAr, LenSx, Catalys and VICTUS are currently the only approved femtosecond lasers for cataract procedures in the US, that doesn’t mean other companies aren’t getting into the game.
For instance, Ziemer, whose Z Model line of lasers are FDA approved for capabilities such as LASIK flap creation and lamellar keratoplasty, is gunning for approval of cataract procedures for its LDV Z8 mobile platform.
It received CE approval in May 2014 for clear corneal and arcuate incisions, capsulotomy, lens fragmentation, as well as all previously covered corneal and presbyopia applications.
This group was initially focused on developing a retinal photocoagulation system. In 2010, that technology was sold to Topcon. Dr. Blumenkranz, in collaboration with William Culbertson, MD, refocused the engineering capacity of Optimedica to develop OCT-guided femtosecond laser treatment of the cornea and lens to facilitate cataract surgery.
In 2013, Abbott Medical Optics (AMO) acquired Optimedica and the result was its foray into femtosecond lasers, the Catalys laser system.
The Catalys laser received 510(k) approval for its femtosecond laser and OCT combination system for creation of a capsulotomy and lens fragmentation in 2011. This was around the same time the VICTUS laser received approval. Subsequently, in February 2012, Catalys received approval for corneal incisions.
The first commercial Catalys system was placed with Professor Burkhard Dick, MD, PhD, in Bochum, Germany, in November 2011. This was followed by placement of the first system in the United States in February 2012.
The Catalys system is currently awaiting an upgrade that will include intraoperative assessment of the steep corneal axis to help treat astigmatism.
Since it acquired Optimedica, AMO has continued to invest in the development of the Catalys system by introducing software upgrades each year.
The liquid optics interface and real-time OCT the Catalys system offers can image several planes to guide laser application.
The Catalys laser system is currently awaiting the release of a new software upgrade that will include intraoperative assessment of the steep corneal axis to aid in treatment of astigmatism. This will give doctors more accurate placement of limbal relaxing incisions and toric alignment taking into account torsional changes with positional alterations.
The company is also working on the development of a smaller patient interface with a decrease in outer diameter from 21 mm down to 19 mm while maintaining an inner diameter of 12 mm to maintain a sufficient surface for maintenance of image integrity.
The LENSAR femtosecond laser system began its rapid evolution in May 2010 when it received 510(k) clearance from the FDA for creation of the anterior capsulotomy during cataract surgery. Early development and experience with the laser occurred primarily in Peru and the Philippines.
In 2010, Louis D. “Skip” Nichamin, MD, of Brookville, Pa., became the first surgeon in the United States to use the laser for lens fragmentation and capsulotomy creation. In March 2011, it received FDA approval for lens fragmentation.
LENSAR received 510(k) clearance for corneal and arcuate incisions by the FDA in December 2012 and April 2013, respectively.
LENSAR’s Augmented Reality technology provides a 3-D reconstruction of the relevant anterior anatomy, resulting in customized treatment.
The LENSAR Laser System’s agnostic platform allows it to be accessible to a range of surgical suit technologies, with the goal of improving cataract surgery outcomes. The first collaborations were with I-Optics (Sarasota, Fla.) and True Vision 3D (Santa Barbara, Calif.) to create an integrated surgical suite. Future collaborations are expected.
Additionally, the LENSAR team has been involved in the development of a laser-based presbyopia treatment through softening of the non-cataractous crystalline lens to recreate some degree of accommodation.
Clinical studies have commenced and study results are expected in the coming year.
The manufacturers of femtosecond lasers have shared goals. The future of laser-assisted cataract surgery involves moving toward higher levels of efficiency, shortening treatment times, decreasing the size of the patient interface, increasing degrees of lens fragmentation and decreasing the rise in IOP pressure during docking.
Additionally, most of the companies have been forming alliances with other corporate entities to create integrated cataract suites characterized by 3D image-guided navigation systems that will help customize and improve precision for our cataract surgery.
This is an exciting time for cataract surgeons. Advancing technology in cataract surgery will help ophthalmologists achieve greater levels of precision, safety and efficiency during cataract surgery, which will benefit both surgeons and their patients.
Observing the evolution of laser integration into cataract surgery has been truly impressive. With all of the companies racing to achieve the most efficient and the safest modality to achieve the ultimate goal of advancing cataract surgery, it’s a win-win situation for us all, and an impressive race to watch at that. OM
About the Author
Kendall Donaldson, MD, MS, is an associate professor at Bascom Palmer Eye Institute, Miami, where she specializes in cornea/external disease and cataract/refractive surgery. She is the Medical Director of the Bascom Palmer Eye Institute in Plantation.
This article was originally printed in Ophthalmology Management, Volume: 18, Issue: August 2014, page(s): 26-28, 30, 31. You can view the article online with images here.