Evolutionary, not revolutionary. That's the phrase used by Paul Arnold, MD, owner of Arnold Vision in Springfield, Mo., to describe the changes in store for cataract surgery over the next five years. Developments in cataract surgery will involve little advances here and there instead of profound changes to the core standards of the procedure. Here's what you need to know to ensure your facility is outfitted to stay ahead of the curve as IOLs, surgical techniques and equipment continue to evolve.
IOL wish lists
A year has passed since the landmark CMS ruling letting patients pay the additional expense for implantation of presbyopia-correcting IOLs. But have the most advanced lenses in today's market caught on? Reviews have been mixed.
As a matter of prudence, some surgeons are waiting to see how the patient-shared billing affects the feasibility of adding Crystalens by Eyeonics, AcrySof ReStor by Alcon or AMO's ReZoom. Also, the additional cost of implanting the new IOLs - as much as $2,500 per eye - is a deterrent to many patients. Mark Packer, MD, FACS, assistant clinical professor of ophthalmology at Oregon Health and Science University and in private practice in Eugene, Ore., says concerns about cost sometimes trump patients' interest in presbyopia-correcting IOLs. His sense is that 50 percent of his patients believe these IOLs would benefit their vision, but only 20 percent of that group can afford the lenses.
The inherent limitations of the three major presbyopia-correcting IOLs have also played a role in the lack of complete acceptance by today's surgeons. The Crystalens, experts say, provides quality distance and intermediate vision, but patients don't get the sharpness in near vision they desire. The ReZoom and ReStor lenses, meanwhile, are weaker at intermediate distances but offer sharp focus at a range of 14 inches. ReZoom and ReStor patients may experience some degree of photic phenomenon, including halos and occasional starbursts from lights, according to clinical data.
"The off-the-shelf solution that everyone sort of hoped for doesn't yet exist," says William Maloney, MD, head of Eye Surgery Associates of Vista, Calif. "We don't yet have the lens that can do it all."
So what do surgeons want in the next-generation IOL? Dr. Maloney hopes for an IOL that can improve the full range of vision, but believes that lens is still years away. In the meantime, surgeons must match patient lifestyles and post-surgery vision goals to the capabilities of the IOLs presently available.
"Current multi-focal and accommodative IOL technology has impressive results, but we can do better," says Dr. Packer. "The main avenues of research involve reducing the optical side effects of multifocality - decreased contrast, halos around lights at night - and increasing the amplitude of accommodation."
Dr. Packer says two promising new multifocal lenses are under investigation in the United States: the Tecnis Multifocal by AMO and the Synchrony dual-optic IOL by Visiogen. The lenses will likely receive FDA approval in 2007 or 2008, offering surgeons and patients additional premium IOL options.
The Tecnis Multifocal adds a diffractive element to the modified prolate aspheric design of the Tecnis monofocal with the intent of improving image quality and contrast sensitivity over other multifocal IOLs, says Dr. Packer. The Synchrony has a dual optic design to increase the amplitude of accommodation over single optic accommodative IOLs such as the Crystalens, he says.
Diopter ranges of implant lenses will also increase in the future, allowing for more precise post-op vision results. Francis S. Mah, MD, of the University of Pittsburgh Eye & Ear Institute, believes this development will lead to an infinite range of presbyopia-correcting capabilities.
While improving functional vision is an important goal of IOL development, Dr. Mah believes decreasing the size of the implants is just as essential. The history of cataract surgery is defined by the incision sizes needed to first remove the cataract, and then implant the new lens. Technology exists today that allows for lens removal through two 1mm incisions, called micro incision cataract surgery, or one sub-2mm incision, known as micro co-axial cataract surgery, says Dr. Mah.
Many surgeons, however, are holding off on using smaller incisions until the implant lens technology matches the lens removal capabilities, says Dr. Mah, who notes that a majority of ophthalmologists today work through sub-3.5mm incisions. "Physicians are trying to roll today's folding IOLs even tighter to squeeze them through smaller incisions," says Dr. Mah. "That seems to work in incisions as small as 2mm to 2.2mm."
In the next two years to five years, Dr. Mah says a gel-like pellet that will fit in a 1mm incision will hit the market. Once implanted, the pellet is hydrated and re-forms into the shape of a lens. Ten years from now, Dr. Mah predicts surgeons will perform cataract surgery with a needle used to liquify and remove the cataract before injecting a gel implant.
Evolution in the OR
As most facility managers know, advances in surgical equipment often require unavoidable upgrades every few years. Budgeting around $5,000 should cover these costs, says Dr. Mah. "Most equipment companies are sensitive to the fixed budgets facilities work with," he says, adding that phaco platforms will likely maintain in the near future, with handpiece accessories becoming available as incision sizes continue to decrease.
To keep your physicians happy, focus on ergonomics, suggests Dr. Mah. He says surgical microscopes are now more user-friendly, citing the development of ceiling-mounted scopes that eliminate the need for moving the pieces between procedures and free valuable floor space in the OR.
Wireless technology will play a major role in improving the OR experience for the surgeon, says Terry Kim, MD, associate professor of ophthalmology and associate director, cornea and refractive surgery, at Duke University Eye Center in Durham, N.C. The many components of today's eye rooms are connected by cumbersome cords and wires, making patient transport difficult. Dr. Kim also believes improvements in OR equipment will let surgeons control OR settings through a foot pedal, most notably allowing the physician to interact directly with the phaco machine, eliminating the need to look away from the surgical microscope.
Dr. Packer says the industry is headed to a further integration of the various surgical tools used to implant lenses. Much like the push-button controls of luxury sedans that automatically adjust to pre-programmed driver preferences, the equipment in the eye room of the future will adjust to match the needs of individual surgeons.
"Even though my staff sets up the room before each case, ergonomics are very important to me," says Dr. Packer, who spends valuable pre-op minutes setting the height of his chair, the position of the patient's head, the tilt of the surgical scope and placement of the phaco machine. Dr. Packer also likes to start each operation with the OR lights set on low after numerous patients complained of bright bulbs shined in their face at the start of cases. Having his personal preferences reset with the push of a button would save the surgical team three to five minutes during room turnovers, says Dr. Packer.
Instead of high-end automobiles, Jack T. Holladay, MD, MSEE, FACS, owner of the Holladay LASIK Institute in Bellaire, Texas, compares tomorrow's wavefront technology to the telemetry displays projected on the canopies of jet fighters. Dr. Holladay explains that wavefront measurements will soon be incorporated into the surgical scope display, allowing surgeons to determine exact refractive measurements of the lens implant while the patient is still on the table. This, he says, will eliminate post-op refractive surprises and dramatically improve surgical outcomes.
Dr. Arnold would like to outfit his eye room with Alcon's Infiniti Vision System. The Infiniti system is used to perform torsional phaco, a new development in cataract removal. The handpiece used in torsional phaco oscillates in a side-to-side motion instead of the forward-and-backward movements of traditional phaco. Torsional phaco is said to remove cataracts in a more efficient manner while using less thermal energy, and some believe the technology may become the standard of care in the near future. "If we could afford the Infiniti system, we would get one," says Dr. Arnold. "I believe this unit would allow us to perform safer procedures while also improving overall outcomes and case efficiency."
Bang for the buck?
Dr. Packer says facilities have to decide if new technology is worth the capital investment. He warns against committing dollars to equipment upgrades if your surgeon is planning to retire over the next five to 10 years. He also believes a surgery center has to perform 1,200 major cases a year to make the investment worthwhile.
Staying ahead of the equipment curve is important for surgeons and managers who want to stay in the cataract surgery game. The baby-boomer population is aging, and that target demographic has high expectations for quality surgical outcomes. "The successful ASC will bring new technology into the OR," says Dr. Arnold. "Presbyopia-correcting IOLs will provide an additional income stream and increased volume if patients are satisfied with the results."
Dr. Maloney, who taught a course on presbyopia-correcting IOLs at this year's ASCRS annual meeting, listened to the feedback of his colleagues and realized many surgeons were waiting to achieve a clear understanding of the premium IOL market before committing capital to the technology. He believes surgeons are now ready to embrace the IOLs and will "make a significant move over the next three years."