While most cataract surgeons remain undecided about femtosecond cataract surgery, a handful of surgical pioneers around the world have leaped wholeheartedly into the commercial use of femtosecond lasers. In interviews with Refractive Surgery Outlook recently, two of these ophthalmic trailblazers talked about what their initial explorations of this ophthalmic frontier have revealed so far.
Buy It and They Will Come
In the west-central German city of Bochum, the ophthalmic center directed by H. Burkhard Dick, MD, PhD, has been inundated for the last several months with requests from patients seeking femtosecond laser cataract surgery. The Institute for Vision Research at Ruhr University Eye Hospital houses Germany’s first OptiMedica Catalys femtosecond laser (OptiMedica, Sunnyvale, Calif.).
Dr. H. Burkhard Dick performs femtosecond laser-assisted cataract surgery.
These patients could have standard phacoemulsification surgery for free through Germany’s national health care system. Instead, they are willing to pay for the entire cost of a femtosecond laser procedure of €1,520 per eye.
When the Catalys arrived last December, Dr. Dick, who is a professor and chairman of ophthalmology at Ruhr, had a two-year plan for recovering the costs of buying and installing the €480,000 laser. He would need 600 femto-cataract cases in the first two years to break even.
But in just six months’ time, the total number of laser cataract cases exceeded 600, with no signs of slowing down, he said.
“I expected it would be hard to do 250 in a year, but patient acceptance has been extremely high. We do not advertise this surgery, but still the people come in asking for the laser,” Dr. Dick said.
Physicians: New Believers
Half a world away in an Australian suburb, corneal and refractive surgeon Michael Lawless, MBBS, FRANZCO, FRACS, has been impressed by the positive responses from his nonrefractive surgeon colleagues. Dr. Lawless practices in a 38-physician eye care group of comprehensive ophthalmologists and subspecialists.
The eight-physician satellite clinic where he is based, in Chatswood, north of Sydney, received its cataract-ready LenSx femtosecond laser system (Alcon, Fort Worth, Tex.) in April 2011. All eight of the Chatswood clinicians now perform laser-assisted cataract surgeries, Dr. Lawless said.
“Even the most conservative general ophthalmologists are using the femtosecond laser for about 50 percent of their surgeries,” he said. His own rate has climbed steadily over the last year to 92 percent.
Germany: Slow Spread of a New Technology
Ophthalmologists in Germany and much of Europe appear to be moving more slowly toward femtosecond laser cataract surgery than their colleagues elsewhere in the world, according to Dr. Dick.
“Europe is just starting with this technology. We have some early adopters but very few,” he said.
He estimated there are fewer than 10 femtosecond cataract lasers in commercial use in Germany, primarily made by LenSx. In all of Europe, he counts two OptiMedica lasers: his own, and another in Switzerland. (An OptiMedica spokeswoman said the company has “a rapidly increasing global installed base, with multiple systems each in the U.S., Germany, Spain, Australia, Switzerland and Japan.” She declined to release exact figures.)
“But the interest is very high among eye surgeons. Nearly every other day we have visitors here to observe our laser in use,” Dr. Dick said.
No Applanation with OptiMedica
ISRS Multimedia Library: Dr. Zoltan Nagy demonstrates femtolaser-assisted cataract surgery.
Dr. Dick said the primary reason he bought an OptiMedica laser was that it delivers the laser treatment without requiring applanation or a high-pressure docking mechanism. “I am convinced that not applanating the cornea is the important portion of the OptiMedica technology,” he said.
He also wanted a laser with built-in 3D high-resolution spectral-domain OCT, automatic pupil detection and preoperative templates of laser spot patterns based on lens hardness.
At scientific meetings this spring,1,2 the Bochum group presented data on their early experience with the Catalys. (They have two papers under review by the European Journal of Ophthalmology.) Their podium presentations highlighted the following:
The unique fluid-filled interface between the eye and laser kept the IOP rise during suction to an average of 10 mmHg (100 eyes). “This is definitely lower than any other femtosecond laser system out there,” Dr. Dick said.
99 percent of laser capsulotomies were “free floating” (400 eyes), with no manual dissection required to complete the capsulorrhexis. This compares to 17.5 percent in a recently published LenSx case series (n=200).3
There were only two complications in the first 400 surgeries—an anterior radial tear, and the subsequent posterior tear with vitreous loss that the anterior tearing precipitated.
In an average of 2 ½ minutes – “vacuum on to vacuum off” – the Catalys made the capsulotomy; cut the main incision, paracentesis and arcuate incisions; and fully fragmented the lens.
Less Phaco Time
But the results that Dr. Dick expects will hold the most significance to clinicians is the reduction in “effective phaco time” (EPT) after pretreating the lens with femtosecond pulses. (See Dr. Dick's slideshow "Experience with the Catalys Precision Laser System," presented at the 2012 Asia-Pacific Academy of Ophthalmology Congress, Busan, Korea.)
“The lens fragmentation is the strongest part. We did prospective trials with 109 eyes, and when we fragmented the lens into 500-micron pieces we were able to reduce total effective phaco time by 96 percent,” he said.
When they reduced the laser fragments to 350 microns, EPT dropped another 80 percent, he said.
Today about 30 percent of the Bochum group’s cases require no phaco power at all to remove the lens, Dr. Dick said. He predicts that someday ophthalmologists with femtosecond lasers for cataract surgery will need phaco power only for the densest cataracts, rated LOCS IV+.
“To me this means that this technology will be the future of cataract surgery,” Dr. Dick said. “Because we know that this is just the beginning. It’s amazing how advanced the lasers are already, but still we are only at the beginning.”
Australia: No Fuss Over Femto Fees
In Australia, some rules of the nation’s universal health care system are giving ophthalmologists a better sense of how much cost influences patient choice of laser versus conventional cataract surgery, Dr. Lawless said. And, so far, paying more has not made patients want laser cataract surgery less.
“Australia is an ideal environment for introducing something like this,” he said. “It’s an open and clear environment, free of distortion by bizarre factors that have nothing to do with the safety and effectiveness of the procedure.”
Approximately 210,000 cataract surgeries per year are performed in Australia,4 which has a combined public-private system of universal health care. Approximately one-third of the surgeries are fully paid for by the government and use only phacoemulsification, Dr. Lawless said.
Extra Cost? No Problem
For the remaining two-thirds of cataract surgeries, surgeons are paid partly by the government, private insurers and patients, he said. The additional cost of a femtosecond laser in a cataract procedure is borne solely by the patient – but they are embracing the new technology enthusiastically, he said.
“Patients are accustomed to having to pay some amount for their cataract surgery. So the femtosecond laser fee [of $450 per eye] doesn’t feel like that much more to them,” he said.
Furthermore, although large randomized prospective trials have not proved this, patients seem willing to pay extra for femtosecond surgery because they perceive it as safer and better, he said.
“They catch on quickly and want laser surgery if the money issue isn’t clouding the picture,” Dr. Lawless said. “They understand safety. They can understand the precision and reproducibility that comes with a laser.”
500 Cases So Far
By late May, Dr. Lawless had performed nearly 500 femtosecond laser cataract surgeries with his clinic’s LenSx laser, which he counts as one of six femtosecond lasers used for cataract surgery in Australia.
He uses the laser for every step in cataract surgery: capsulotomy, corneal incisions, pre-fragmenting the crystalline lens to minimize phaco energy, and correcting astigmatism with limbal relaxing incisions (LRIs).
He opts against the laser in about 8 percent of cataract surgeries due to anatomical issues, such as small pupils or tight orbits. But he expects the impact of these barriers to decrease when Alcon introduces a smaller docking cone suitable for eyes with a narrow papebral fissure.
A Unique Approach to LRIs
Based on his clinical experience Dr. Lawless believes LRIs are a unique and particularly promising application of the femtosecond laser for refractive correction.
“They’re totally intrastromal. That is a new thing – you can’t do that with any other technology,” he said. “This allows you to deal with astigmatism in a very precise way, without having to deal with toric intraocular lenses.”
He predicts that laser-made LRIs will improve the precision and predictability of LRIs and make it possible to fine-tune patients’ acuity by eliminating small amounts of astigmatic error – levels lower than the smallest available toric IOL power (0.75 D).
“That is my observation. I can’t prove it yet with data,” he added.
Why LenSx
Dr. Lawless, who is a medical adviser to Alcon’s femtosecond laser team, said he chose the LenSx device because it was designed by the group who first engineered femtosecond lasers for cataract surgery. He expects them to produce a steady stream of improvements for the LenSx in the future.
“I thought the people who developed this technology are the best team to take it forward. When Alcon bought the LenSx company, they wisely kept the team intact,” he said.
What About the Learning Curve?
Dr. Lawless and colleagues have published two peer-reviewed papers this year containing results from their early experiences with femtosecond laser cataract surgery.3,4 In the more recent paper published in May by Ophthalmology, 84.5 percent of eyes achieved a CDVA of 20/30 or better at two weeks post-op. However, the surgeons reported experiencing an “unacceptably high” number of complications in their initial 200 LenSx cases.
For instance, the rate of anterior radial capsular tears (n = 8) and posterior capsular tears plus vitreous loss (n = 7) was higher in the 200 laser cases than it was in 1,000 conventional phaco-only cataract surgeries (11 capsular tears, 8 anterior and 3 posterior) performed by the same surgeons prior to laser’s arrival, the study found (P < 0.001).
“Although femtosecond lasers increase the ease and predictability of the steps involved in cataract surgery, there is a definite learning curve involved in carrying out this procedure,” they wrote. “The initial intraoperative complication rate was unacceptably high but settled rapidly with experience.”
Financial Interests
Dr. H. Burkhard Dick is a consultant for OptiMedica, AMO, Bausch + Lomb and Novartis.
Dr. Michael Lawless is a medical adviser to Alcon LenSx USA.
References
1. Dick HB. Femtosecond laser-assisted refractive cataract surgery using the Catalys System: first clinical results. Paper presented at: ESCRS Winter Meeting; March 2, 2012; Prague, Czech Republic.
2. Dick HB et al. Experience with the Catalys precision laser system. Paper presented at: Asia-Pacific Academy of Ophthalmology Congress; April 16, 2012; Busan, South Korea.
3. Bali, SJ, Hodge, C, Lawless, M, Roberts, TV, Sutton, G. Early experience with the femtosecond laser for cataract surgery. Ophthalmology. 2012;119 (5):891–899.
4. Lawless M, Hodge C. Femtosecond laser cataract surgery: An experience from Australia. Asia-Pacific Journal of Ophthalmology. January 2012: 5-10.
