CRSToday Europe News — October 2007

NEWS FROM THE XXV CONGRESS OF THE ESCRS

AMO Technologies Introduced to European Market
Advanced Medical Optics, Inc. (AMO) announced the launch of three new refractive technologies during the XXV Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in Stockholm, Sweden. The Tecnis One-Piece IOL and the Tecnis multifocal acrylic IOL, along with the WhiteStar Signature phacoemulsification system (launched in the United States in April at the American Society of Cataract and Refractive Surgery [ASCRS]), are now available in Europe.

The Tecnis One-Piece IOL targets zero spherical aberration to provide rejuvenated vision, more like that of a younger adult with no spherical aberrations. (For more information see Innovations on page 77.)

The Tecnis Tri-Fix design provides three-point fixation for exceptional stability. Refraction stabilizes quickly after the implantation procedure and remains stable after postoperative refraction.

"The new Tecnis multifocal acrylic IOL combines the outstanding visual performance benefits of the Tecnis multifocal optic design with a proven hydrophobic acrylic material that provides unmatched clarity," said Michael Knorz, MD, of Germany, in a news release. "I am looking forward to my clinical experience to confirm the benefits of this new premium presbyopia-
correcting IOL."

The WhiteStar Signature system provides the ultimate chamber stability and effectively reduces postocclusion surge by a significant margin. Fusion Fluidics contains advanced chamber stability safety features; its high flow and vacuum capabilities provide a peristaltic flow of up to 60 cc/min and maximum vacuum of 650 mm Hg.

The launches mark the continued expansion of AMO's advanced product portfolio offering eye care professionals a complete refractive solution.

Bausch & Lomb Launched Vision Enhancement System
Bausch & Lomb (Rochester, New York) launched its Stellaris Vision Enhancement System in Europe during the XXV Congress of the ESCRS. Several leading European surgeons also presented first clinical experiences with the system for both bimanual and coaxial microincisional cataract surgery.

"The Stellaris system offers greater performance, control, and versatility than its predecessors, with optimized cutting to deal with even the hardest nuclei," said H. Burkhard Dick, MD, of Germany, after more than 50 cases with the Stellaris. "The improved fluidics are increasingly important for chamber stability in both biaxial and microcoaxial phaco. Surgical control is improved in the wide range of lens opacities." Professor Dick is a member of the CRST Europe Editorial Board. "The system lets surgeons operate at our own pace when using smaller incisions, without compromising speed or efficiency, while delivering excellent optical outcomes."

The Stellaris functions in either vacuum-based (venturi-like) or peristaltic flow-based modes. It may be optimized for phaco technique such as microcoaxial or bimanual microincisional cataract surgery.

One-Month Results for New Excimer Laser
Good visual acuity, high predictability, and low variance rates were reported in the 1-month results of a recent multicenter LASIK study using the Schwind Amaris (Schwind eye-tech-solutions, Kleinostheim, Germany). The study, performed by Francesco Carones, MD, of Italy, and other Schwind eye-tech-solutions reference surgeons, included 389 eyes with preoperative spherical equivalents ranging from -0.50 to -8.25 D, with astigmatism up to -5.00 D. In 74% of eyes, the planned refractive result was achieved within a minimum deviation of ±0.25 D, 93% were ±0.50 D, and 100% were within ±1.00 D, at 1 month postoperative.

During the same postoperative follow-up, 92% of patients achieved a UCVA of 20/20 or better, with no eye realizing a visual acuity of less then 20/32. A UCVA of 20/25 or better was achieved in 99% of eyes, with more than 32% of patients seeing 20/16 or better.

Additionally, no trend in over- or undercorrection was detected during the 1-month follow-up.

Dr. Carones has used seven laser systems during his career and noted that he valued the full-flexibility that the Amaris gives to the refractive surgeon. "I very much like the ergonomics of the new laser. You work in a convenient positions—all your operational controls are easy to reach and clearly arranged," he said in an interview with Schwind-eye-tech solutions. "I'm impressed by the immediate postoperative day 1 results: The vast majority of my patients had a BCVA of 20/20. From this, we can draw the conclusion that the recovery time with the Schwind Amaris is very short." Dr. Carones is a member of the CRST Europe Editorial Board.

Alcon Reported Progress in Takeover Action
Alcon, Inc. (Hunenberg, Switzerland) acquired 70% of the outstanding shares in WaveLight AG (Erlangen, Germany). Since announcing its intention to acquire the German laser manufacturer in June, Alcon amended its original offer of ?10 to ?15.

Earlier this month, Carl Zeiss Meditec AG (Jena, Germany) agreed to sell its 5% stake in WaveLight to Alcon after announcing that it would not tender a takeover offer to rival WaveLight's pending deal with Alcon.

"Our progress in acquiring WaveLight is accelerating, and these latest milestones are significant steps in continuing our momentum," said Cary Rayment, Alcon Chairman, President, and CEO, in a company news release.

In a second announcement, Alcon, Inc. plans to establish Fribourg, Switzerland as the new central location for an expansion of the company including a relocation of finance, information technologies, logistics, and other centralized administrative operations from their Hunenberg site. This move offers the company several tax benefits over the next 5 years, which will be reinvested into the company by funding additional research and development projects and an increase in strategic marketing and sales programs, according to a company new release.

The company also announced the establishment of a new European area and marketing management center in Geneva, Switzerland. Some sales and marketing activities will remain based out of Hunenberg.

Ophthalmic Training Center Opened in Indonesia
Michael Kaschke, Director of Carl Zeiss Meditec AG, has opened an ophthalmic training center at the Cicendo Hospital in Bandung, Indonesia, in collaboration with the International Agency for the Prevention of Blindness (IAPB) and the Indonesian government.

Carl Zeiss Meditec AG is supporting the foundation of the training center with a donation of $200,000, which will be used for training and equipment. They are also donating equipment to the center.

The opening of the training center is part of the Vision 2020 initiative to eliminate avoidable blindness in the world by the year 2020. Carl Zeiss Meditec AG is the first corporate sponsor of Vision 2020 and has proposed to the IAPB to install training centers in various regions of the world.

A national eye health program was launched in Indonesia in 1978. Studies, however, show that despite joint efforts, the rate of blindness had increased from 1.2% in 1978 to 1.5% in 1996. The main cause of blindness is cataracts, with a share of more than 50%, and 1.5 million people in Indonesia are afflicted.

Zeiss Acquired Acri.Tec, Settled Patent Dispute
Carl Zeiss Meditec, AG, (Jena, Germany) completed its acquisition of Acri.Tech AG (Berlin). Acri.Tech manufactures the Acri.LISA refractive-diffractive multifocal and the Acri.Smart microincision cataract surgery IOLs.

In a news release, Ulrich Krauss, Carl Zeiss Meditec AG's President and CEO, said that the addition of Acri.Tec's IOLs to Zeiss' portfolio will allow his company to "cover the entire spectrum of IOLs—ranging from simple monofocal IOLs for the treatment of cataracts to technologically sophisticated multifocal and microincision lenses for refractive surgery."

Last week, the IntraLase subsidiary of AMO reported that it issued a nonexclusive, royalty-bearing license that allows Carl Zeiss Meditec AG to use IntraLase's patent portfolio to provide femtosecond technology for corneal surgery. The introduction of Zeiss' Visumax femtosecond laser system during the 2006 American Academy of Ophthalmology (AAO) Annual Meeting in Las Vegas prompted IntraLase Corp., which was in the process of being acquired by AMO, to file a lawsuit. The lawsuit claimed that, "Zeiss breached an intellectual property agreement with IntraLase by improperly using confidential and proprietary information of IntraLase, which Zeiss wrongfully induced IntraLase to disclose."

In January 2007, the US Food and Drug Administration (FDA) cleared the Visumax femtosecond laser (Carl Zeiss Meditec AG) for the creation of corneal flaps during refractive surgery. The laser can also be used to perform femtosecond lenticule extraction, an investigative, all-in-one refractive procedure that reshapes the cornea without excimer laser ablation.

New Needle Created for MicroFlow
Bausch & Lomb's MicroFlow family of needles has been enhanced by the addition of the MicroFlow 2.2 needle, for use in microcoaxial incision cataract surgery.

With the MicroFlow and MicroFlow Plus needles currently catering to 2.65- to 2.6-mm coaxial surgery, the provision of the MicroFlow 2.2-mm needle will enable coaxial surgeons to reduce incision size and begin the transition to 1.8-mm coaxial microincisional cataract surgery, according to a company news release. Bausch & Lomb's Akreos MI60 IOL, specifically designed for 1.8-mm microincisional cataract surgery, can also be implanted with an in-the-bag technique when performing 2.2-mm microcoaxial cataract surgery.

Learning Curve May Affect Outcome of LASEK
A retrospective study of 56 eyes that underwent alcohol-assisted LASEK for mild-to-moderate myopia showed that the surgeon's experience with the procedure affected postoperative outcomes. The study was published in The Journal of Cataract and Refractive Surgery.

When the investigators compared the UVCAs of the first 28 eyes (group one) and the last 28 eyes (group two) treated by the same surgeon, they found that more than 96% of those in group two achieved visual outcomes within ±0.50 D of their intended correction versus only 75% in group one, at 3 months postoperatively. In addition, two eyes in group one (7%) and no eyes in group two lost two or more lines of BSCVA after LASEK.

Because the data showed that, "the refractive results obtained with LASEK after 1 year of practice were better than those obtained at the beginning of the learning curve," the investigators suggested that the surgeon's experience should always be considered when "interpreting the published outcomes of this procedure." They hypothesized that the greater incidence of overcorrection in group one may be due to inexperienced surgeons taking longer to separate the epithelial flap, which resulted in greater desiccation of the stroma.

Quantifying the Biomechanics of Keratoconus
To evaluate the Ocular Response Analyzer's (Reichert Ophthalmic Instruments, Depew, New York) utility for detecting keratoconus, investigators at the Instituto Oftalmológico de Alicante Vissum, in Alicante, Spain, used the device to measure the corneal hysteresis and the corneal resistance factor in normal (n=65), post-LASIK (n=65), and keratoconic eyes (n=21). These parameters measure the cornea's viscoelasticity and overall resistance to deformation, respectively.

At 1 month postoperatively, the investigators noted that corneal hysteresis and the corneal resistance factor decreased significantly (10.44 ±1.74–9.3 ±1.9 mm Hg; 10.07 ±1.97–8.1 ±1.8 mm Hg, respectively) in the eyes that underwent LASIK. Compared with the post-LASIK eyes, the keratoconic eyes' corneal hysteresis measurements (mean, 7.5 ±1.2 mm Hg) and corneal resistance factor (mean, 6.2 ±1.9 mm Hg) were statistically significantly lower (P<.001). Additional analysis of the keratoconic eyes showed a significant negative correlation between an eye's corneal hysteresis and the keratoconus grade (P=.008). These findings suggest that the biomechanical properties measured by the ORA could be good diagnostic indicators of keratoconus. Furthermore, "future studies of the influence of refractive surgery techniques … on corneal biomechanic properties or the ability of these new parameters … to distinguish patients with subclinical keratoconus or keratoconus-suspect patients" may help surgeons identify patients at risk of developing corneal ectasia after refractive surgery.