Fifty years after the idea for phacoemulsification came to Charles Kelman, MD, few would have predicted that surgical platforms would evolve to where they are today.
Manufacturers of ophthalmic surgical equipment have responded to surgeons’ needs and provided tools to make cataract surgery easier ever since Charles Kelman, MD, introduced phacoemulsification (phaco) 50 years ago. Here’s how three of the biggest players in the field-Alcon Laboratories, Bausch + Lomb, and Johnson & Johnson Vision-have updated their phaco offerings through time.
Alcon’s lineage goes back to Dr. Kelman’s Cavitron, the first commercial phacoemulsification unit, said Mikhail Boukhny, PhD, vice president and head of surgical instrumentation for Alcon.
“It was absolutely breakthrough for its time,” Dr. Boukhny said.
A total of 50 units were made, and one of the industrial-grade stainless steel units is on display at the company’s research and development site in Lake Forest, CA.
“Unlike today’s standards, there was no proportional control of fluidics or phaco power,” he explained. “It was pretty much on and off.”
Of course, phaco surgery at that time was more complicated as well, often lasting hours and using much more fluid.
The manufacturer had several phaco units through the years, but the Alcon 10,000 Master unit was introduced at the beginning of phaco’s growth period, Dr. Boukhny said.
“It still required skill, but surgeons got outcomes that were significantly better than what they would get with extracapsular cataract extraction in those days,” he said.
The ability to go in through smaller incisions made a big difference surgically. The Legacy Series 20,000 coincided with the broad availability of high-quality foldable IOLs, enabling smaller incisions for the entire surgery. With this approach, outcomes improved further, there was greater and more rapid patient satisfaction, and the once exotic phaco approach became standard, Dr. Boukhny said.
The Infiniti phaco unit was introduced in 2003, followed by the introduction of torsional ultrasound (OZil) in 2006.
“This significantly reduced repulsion and heat associated with longitudinal phaco,” Dr. Boukhny said. “There was less turbulence, better consistent outcomes, and it made surgery easier for beginning surgeons.”
The Centurion Vision System was introduced in 2013. Two major innovations-active fluidics and balanced tip-further improved chamber stability and reduced amount of heat generated. Even in more challenging cases-including comorbidities, such as pseudoexfoliation, patients taking tamsulosin (Flomax, Boehringer Ingelheim Pharmaceuticals), and hard cataracts--outcomes are often consistently good, thanks to the latest phaco technology, Dr. Boukhny said.
The future of phaco will be more automated, Dr. Boukhny predicted.
“I believe incision sizes will continue to get smaller,” he said. “Phaco will keep up with and stay ahead of innovations in IOLs. The surgery will benefit from laser-assisted modalities, where it will combine with phaco what the laser is good at-creating a capsulorhexis and fragmenting the lens.”
Phacoemulsification itself will play a smaller role in future surgery, which will largely be controlled by fluidics, he noted.
Bausch + Lomb
The first system introduced by Storz-which later became part of Bausch + Lomb-was the DAISY (Digital Aspiration Irrigation System) in 1986.
“It had a lot of firsts for the industry,” said Tom Moore, director of surgical equipment research and development at the company.
One such first was vacuum-based aspiration. Though this concept was similar to flow-based systems, Moore sees it as a key distinction.
The other new feature on the DAISY was an ultrasound handpiece that ran at a frequency of 28 kHz versus the higher frequencies used by other units. Yet, one more feature was a patented user interface inspired by automated teller machines.
The Premiere system that came next had a similar look and user interface, but through rigorous design methods was more reliable and could be used at altitudes above 5,000 feet.
The year 1997 brought along the Millennium phaco system, which was modular in design.
“That wasn’t necessarily of great interest to surgeons at the time, but it allowed us to introduce a platform that could be continually upgraded,” Moore explained.
Surgery facilities could expedite repairs as needed by swapping modules and keep the unit state-of-the-art with the addition of new surgical modules as they became available. The Millennium also was the first Bausch + Lomb system that used Windows software.
Stellaris, the fourth-generation system, was introduced in 2007 and incorporated all previous technology and surgical features. Moore describes it as more aesthetically pleasing than its predecessors. New features included a wireless foot control and the ability to operate using only electricity without the need for compressed gas. This made it more attractive for smaller institutions and global markets.
Stellaris Elite, the current iteration that was introduced at this year’s meeting of the American Society of Cataract and Refractive Surgery in Los Angeles, has integrated new features like adaptive fluidics. It also has capabilities for both cataract and retina surgery, said Chuck Hess, vice president and manager of U.S. surgical at Bausch + Lomb.
Going forward, the company plans to continue its focus on streamlining surgical efficiency-part of the idea of having cataract and retina capabilities in one machine-and also will focus in smart use of big data and cloud-based management of information, he said.
A team of cataract and retina surgeons is currently working with the company to help pinpoint how data collection would be most useful for the surgeon.
“It’ll be an evolutionary process, much like the iPhone,” Hess said. “We continue to believe that data will be critical, including how we can use information from our surgical systems to enhance efficiency and effectiveness.”
Johnson & Johnson Vision
Abbott Medical Optics (AMO) was recently acquired by Johnson & Johnson Vision (J&J Vision). Although AMO has a long history within phaco, J&J Vision had a foray into phaco that actually predated AMO, said Leonard Borrmann, J&J’s vice president of research and development for surgical platforms.
“The Site Microsurgical System was a tabletop unit launched in the mid-80s by IOLab, a division of J&J, and was our first extension of Dr. Kelman’s original invention,” Borrmann said.
Fast forward a few years to 1988, and AMO, at that point a division of American Hospital Supply, launched its first phacoemulsification unit called the Four Plus, which had a large handpiece and was an early attempt to better harness fluidics to help manage the anterior chamber.
Next came the Phaco Plus, which reflected the industry’s focus on increasing vacuum and flow to reduce thermal risk at the cornea from the vibrating handpiece.
The Prestige system was launched in 1992 and was the first closed-loop phaco unit from AMO. It had improved software to help the surgeon reach higher levels of vacuum and flow.
Then the Sovereign was introduced in 1997.
“The Sovereign System was a big-box phaco machine with improved fluidics and outstanding performance,” said Borrmann, noting the company was Allergan Medical Optics by that time.
The Sovereign Compact was the first small footprint tabletop unit and came along in 2001. It was targeted for emerging markets. It had both disposable single-use fluidics cassettes as well as a reusable cassette.
In 2002, the WhiteStar handpiece was introduced as an upgrade to the Sovereign System. It was the first micropulsed ultrasonic handpiece and was built on the idea of a more elegant handpiece about the size of a MontBlanc pen (it was even named for the white star that appears on the tip of a MontBlanc, Borrmann said). The WhiteStar system allowed surgeons to control the delivery of energy at the tip.
The WhiteStar Signature phaco unit soon followed in 2007 and the unit was the first phaco system to have both peristaltic and venturi pump options for surgeons, according to Borrmann.
Two new handpieces were introduced around 2010, the ELLIPS and the ELLIPS-FX, which combined both longitudinal and elliptical motion into a single handpiece to improve the efficiency of ultrasonic energy delivery.
In 2015, the company launched the Compact Intuitive System as a replacement for the Sovereign Compact, as well as the WhiteStar Signature Pro, which was an improvement on the WhiteStar Signature unit.
Borrmann believes in the future the phaco unit will function as the workstation of the operating room, and will have the ability to work seamlessly with the femtosecond laser technology geared toward cataract surgery.
“It wouldn’t surprise me if one day there is a replacement for ultrasound, but given phacoemulsification is still a preferred practice 50 years later, it wouldn’t surprise me if it endures another 50 years,” he said.