Medical Device Daily Contributing Writer

WAILEA, Hawaii The annual Hawaiian Eye Meeting, which took place here last week, has increasingly become a “go to“ event for ophthalmologists and industry. Meeting in a casual atmosphere, physicians have the opportunity to hear the most up-to-date clinical information, while industry is able to gain access to the doctors in a very relaxed venue.

Once again, there was record attendance, as close to 1,000 physicians from all over the U.S. gathered here amidst picture-perfect Hawaiian weather.

The landscape for ophthalmic surgery, notably cataract and refractive surgery, has changed dramatically in the past year or so, with the debut of new multi-focal (MF), phakic and spherical aberration correction intraocular lenses (IOLs). A key development occurred in early March 2005, when the Alcon (Fort Worth, Texas) ReSTOR lens and the Advanced Medical Optics (AMO; Santa Ana, California) ReZoom both gained FDA approval. Both lenses have enjoyed spectacular commercial acceptance since their launch.

In an interesting luncheon talk titled “Making Sense of Today's IOL Choices,“ Louis (Skip) Nichaman, MD, of the Laurel Eye Clinic (Brookville, Pennsylvania), noted that “there has been an exponential rush of new technology in the past year or so. The challenge for ophthalmic surgeons is how to sort through these myriad choices.“

A second important issue impacting ophthalmic surgeons occurred in May 2005 when the Centers for Medicare & Medicaid Services (CMS; Baltimore) granted ophthalmic surgeons and their patients an enormous benefit by agreeing to allow the Medicare patient who desires the highest-technology IOLs the opportunity to pay the difference between a standard lens and a premium lens.

In an article in the June 15, 2005, issue of Ocular Surgery News, cataract and refractive surgeon William Maloney, MD, of Eye Surgery Associates (Vista, California), said, “It is difficult to overstate the importance for cataract surgeons of the recent CMS ruling allowing a private-pay option for presbyopia correction. Besides acknowledging the value of a new generation of reading vision IOLs, this ruling goes further by formally recognizing the added refractive components of cataract surgery utilized specifically to enable lens implant presbyopia correction as a constellation of optional, uncovered services by the surgeon.“

Ophthalmic surgeons, notably those devoted to refractive surgery, are probably the most business-minded, patient-oriented physicians in the U.S. today. Thus, it was no surprise that at this year's Hawaiian Eye meeting, that numerous lectures and symposia specifically addressed the CMS ruling, the advent of new technology and how to develop a successful refractive and cataract surgery in this new environment.

A typical talk, titled “The Refractive Patient: Expectations and IOL Choices,“ was delivered by Rosa Braga-Mele, MD, director of the cataract unit of Mt. Sinai Hospital (Toronto), who said that potential candidates for refractive cataract surgery have “high expectations,“ and that the surgeon must understand and address these expectations to keep the patient satisfied.

“A happy patient is better than achieving an arbitrary acuity value,“ she said.

This theme was echoed by several other speakers during the week. For example, Eric Donnenfeld, MD, of Ophthalmic Consultants of Long Island (Rockville Centre, New York), noted in a luncheon talk that the availability of multi-focal and accommodating IOLs has “revolutionized the rehabilitation of today's cataract and refractive patient,“ and that these patients are “increasing their demand for unaided visual acuity.

“This is the year of refractive IOL surgery,“ said Donnenfeld, who noted that the availability of these new IOLs is “dramatically changing the way all ophthalmic surgeons practice cataract and refractive surgery.“ He added that “all cataract surgery is becoming refractive surgery because patients want to avoid reading or distance glasses if at all possible.“

Donnenfeld discussed several key tenets of his surgical practice that have enabled him to become successful. He emphasized that surgeons must hone their surgical skills through education and practice, while paying careful attention to marketing of their skills to potential patients. He emphasized “four C's“ as keys to success in a cataract/refractive practice.

“You must be confident in your technique, comfortable in your knowledge, committed to your patients and staff and continue to change to meet new technology and shifting patients' expectations,“ Donnenfeld said.

The enthusiasm for new IOL technology is tempered by the realization that today's multi-focal and accommodating lenses still leave room for significant improvement in the future. For example, several speakers noted that Alcon's ReSTOR lens, while excellent for near and far distance, is a compromise for intermediate (i.e., computer) distance.

Similarly, the ReZoom lens from AMO is very effective in intermediate and far distance but can be deficient for some patients in the near field. Both the ReSTOR and ReZoom lenses also cause some patients to experience halos and glare, which can be very disconcerting, depending on the nature of their activities.

Finally, the Crystalens from Eyeonics (Aliso Viejo, California), the only accommodating IOL approved to date, does not have a UV blocker and may not work for all patients. The lead story in the Jan. 15 issue of Ocular Surgery News contained a lengthy article titled “Round Table: Philosophy of mixing IOLs for Presbyopia Spurs Debate.“ Several refractive surgery experts debated the best way to deal with presbyopia, taking advantage of the new lenses to give their patients the best overall vision.

No clear consensus emerged, with some MDs opting for a “mix and match“ strategy, while others preferred to stay with one type of lens and manage the patients' needs and expectations carefully.

Richard Lindstrom, MD, co-program director of the Hawaii meeting and founder of Minnesota Eye Consultants (Minneapolis), is a believer in mix-and-match, using either a ReZoom or Crystalens in one eye and a mono-focal IOL in the other eye. He noted that “there is a historical track record of mixing slightly dissimilar IOLs,“ and it has worked very well for him.

Lindstrom gave a very positive talk on the Crystalens, noting that it provides high quality vision at both distance and intermediate, causes the least glare and halos relative to multi-focals, provides excellent night driving vision and works especially well in a mix/match strategy. He also noted that the 2005 re-design of the Crystalens to create a square edge to reduce post-capsular opacification had been very successful and that its new injector delivery system has reduced operating room time and allowed for a sub-3 mm incision.

He concluded his talk by saying that the Crystalens, which is the first true accommodating IOL available in the U.S., “works well and could be your lens of choice.“

Although it has been available in the U.S. for several years, a procedure that is quietly enjoying strong momentum in refractive surgery is Near Vision CK (conductive keratoplasty), which is marketed by privately owned Refractec (Irvine, California).

CK utilizes a very thin probe to deliver a controlled release of radio frequency energy to heat and shrink the corneal tissue, effectively steepening the cornea to achieve the desired refractive effect. The minimally invasive CK procedure takes less than three minutes and is done in-office with only topical anesthesia.

CK was initially approved by the FDA for the treatment of hyperopia in April 2002 and in March 2004, Refractec gained FDA approval for the treatment of presbyopia.

The company is currently in the midst of two trials that could further expand its market penetration. First, it is seeking expanded approval to enhance near vision in post-LASIK patients. Second, late last year the company announced the launch of a study of its relatively new LightTouch, which involves a neutral-compression technique that appears to deliver even more consistent, repeatable results.

NearVision CK was ranked the No. 1 non-laser refractive procedure in the U.S., according to Market Scope's (Manchester, Missouri) 2005 Annual Survey of Cataract and Refractive Surgeons. An estimated 150,000 procedures have been performed since it debuted in the U.S. market.

Speaking at a packed early breakfast meeting here last week, Dan Surrie, MD, of Durrie Vision (Overland Park, Kansas), described CK as a “cornerstone to a successful presbyopia practice.“

He said there is a “huge target market“ of potential CK patients who can benefit from the procedure. He urged his colleagues, who historically have been skeptics of thermal corneal approaches due to the failure of other techniques, to re-consider it and realize that it is safe, effective and easy to learn. Moreover, Durrie said his confidence in CK is so high that he personally has successfully treated 30 ophthalmologists.

Durrie noted, “I believe that CK has a natural place in any refractive surgery practice and can help make that practice very lucrative.“