CRSToday Europe News — April 2008

Accommodating IOL to Launch in Europe
Bausch & Lomb said the Crystalens Five-0 will be available some time this year.
By Leah D. Farr, News and Industry Editor

The US Food and Drug Administration (FDA)-approved Eyeonics Crystalens Five-0 accommodating IOL (Bausch & Lomb, Rochester, New York; Figure 1), will soon be launched at specific sites in Europe, according to Paul Barros, Vice President of International Business Development for the Crystalens division of Bausch & Lomb.

The Crystalens mimics the eye's natural focusing ability and uses 100% of available light rays at all distances of vision, according to the company. The lens has received the Conformité-Européenne mark (CE); however, Bausch & Lomb has not yet begun commercial activities in Europe. Instead, several top surgeons have been selected to perform 10 bilateral cases each. Information from these cases will be used to create a clinical registry, Mr. Barros said in a telephone interview with CRST Europe. This registry will then be used as a clinical reference base for European doctors considering incorporating the Crystalens Five-0 into their practice. Registry completion is anticipated by June.

Registry participant and CRST Europe Editorial Board member A. John Kanellopoulos, MD, of Greece, said he has seen good results so far with the lens.

"I have been impressed with the excellent calculation of IOL power [in the Crystalens Five-0]. At 6 months postoperatively, all of my patients can read at least J3 for near vision," Dr. Kanellopoulos said in an e-mail to CRST Europe. "Although the accommodative effects of the lens need longer follow-up, the quality of night vision that the Crystalens offers patients is comparible to my Restor [Alcon Laboratories, Fort Worth, Texas] and ReZoom [Advanced Medical Optics, Santa Ana, California] cases.

"I am interested to see whether this kind of fantastic near-vision effect will remain long term," Dr. Kanellopoulos added.

Sheraz M. Daya, MD, FACS, FRCS(Ed), of London, has participated in four registry cases to date.

"The lens is an absolute delight to implant," he said. "Unlike the Crystalens AT-45, which had to be squeezed through an incision with forceps, the new lens is easily implanted through a 2.7-mm incision using an injector and cartridge." Dr. Daya is the Co-Cheif Medical Editor of CRST Europe.

The Crystalens Five-0 launch in Europe will begin at the 2008 European Society of Cataract and Refractive Surgeons (ESCRS) meeting in Berlin.

Bausch & Lomb, which recently acquired Eyeonics—the developer of the Crystalens Five-0 and next generation Crystalens HD-100—will also begin working with large commercial accounts throughout Europe this summer.

"We will work with these accounts and train their cataract surgeons on the preoperative workup, in situ lens placement, and surgical techniques designed to optimize lens performance and patient satisfaction," Mr. Barros said. "Although this is subject to some timing issues, the plan is to have the Crystalens Five-0 available in the European markets this year."

The highly anticipated next-generation Crystalens HD-100, which is not currently CE marked, is expected to be launched in the United States first and then rolled out to other markets worldwide, Mr. Barros added.

The Crystalens HD-100, designed in collaboration with Eyeonics optical engineers, J. Stuart Cumming, MD, the inventor of the Crystalens and former CEO of Eyeonics, and Richard L. Lindstrom, MD, of Minneapolis, incorporates a lens design that optimizes the shape of the lens to enhance near vision, while retaining the excellent distance and intermediate vision achieved by the Five-0.

"The Crystalens HD-100 incorporates an innovation in the central optical zone that delivers better near vision without compromising distance or intermediate vision or mesopic contrast sensitivity. The result is that patients will be able to read more easily and enjoy enhanced overall visual quality throughout the accommodative spectrum," Dr. Lindstrom said.

Satisfaction Among LASIK Patients High, Study Found
Worldwide, an average of 95.4% of LASIK patients are satisfied with their vision, according to a review of the global scientific literature. The meta-analysis, led by Kerry Solomon, MD, at the Storm Eye Institute of the Medical University of South Carolina, examined nearly 3,000 peer-reviewed articles published over the past 10 years in clinical journals from North and South America, Europe, Asia, Africa, and Australia. Follow-up of the patients ranged from 1 month to 10 years.

The study found that:

• Approximately 95% of patients would recommend LASIK to a friend or would elect to undergo the procedure again;
• More than 95.2% of patients who underwent LASIK in the United States are satisfied with their postoperative results; and
• The total range of satisfaction rates in individual studies fell between 87.2% to 100%.

"Once a technology matures to this point, a profession committed to continual improvement will naturally focus on improving patient satisfaction," said Richard L. Lindstrom, MD, president of the ASCRS. "While patient satisfaction is extremely high, we recognize that there are patients who have unsatisfactory outcomes … the well being of all of our patients is central to what we do and what we are. As such, and as the history of medicine has shown, we are committed to advancing our technology, patient selection, and surgical techniques so that we can continue to enhance the quality of our patients' lives."

Not everyone is a good candidate for LASIK, Dr. Solomon noted. "Along with continued advances in technology, exploring a holistic approach to patient screening with considerations for both physical and psychodynamic factors may be the answer to further increasing patient satisfaction," he said.

Post-LASIK Dry Eye Linked to Preoperative Tear Levels
Patients who meet a specific threshold of tear production are less likely to develop chronic dry eye syndrome after LASIK, according to a study published in Investigative Ophthalmology and Visual Science. This information could lead to reliable screening criteria for ophthalmologists, the study's authors said.

Principal investigator Darlene A. Dartt, PhD, and colleagues at the Schepens Eye Research Institute in Boston, found that patients who had a presurgical tear production greater than 20 mm of wetting on the Schirmer strip in 5 minutes were not likely to develop chronic dry eye syndrome after LASIK. Patients who produced fewer tears in the same amount of time were more likely to develop the complication.

Twenty-four patients were included in the study, which measured tear production using the Schirmer test with and without anesthesia. Rose bengal staining, central corneal sensitivity, nucleus-to-cytoplasmic ratio, and goblet cell density were evaluated 2 weeks preoperatively and at 1 week, 3 months and 9 months, postoperatively. Patients also described their pre- and postoperative dry eye experience via questionnaire.

According to Dr. Dartt, the study will soon be expanded to a larger patient set (including those with previous PRK treatment) to validate the outcomes.

Phakic IOL Showed Stable Results at 3 years
The Artisan (Ophtec BV, Groningen, Netherlands) phakic IOL corrects refractive error in patients with high myopia with a high degree of predictability, long-term stability, and improvement in contrast sensitivity, according to results of a 3-year FDA study.

A total of 684 patients with axial myopia (range, -4.50 D to -22.00 D) were enrolled in the prospective, open-label, noncomparative, multicenter clinical trial. Efficacy was determined by UCVA measurements, refractive predictability and stability outcomes, patient satisfaction ratings, and contrast sensitivity. BCVA, intraocular pressure, slit-lamp observation, endothelial cell density, and complications were factors in the safety assessment of the lens.

Beginning at 6 months postoperatively, researchers found that the UCVA was 20/40 or better in 84% of eyes and 20/25 or better in 51.9%. Additionally, 71.7% of patients were within 0.50 D of the target refraction and 94.7% were within 1.00 D. At 3 years, 54% of eyes had gained 1 line or more of visual acuity; only 7% had lost one line or more. Approximately half of the adverse events and repositioning surgeries occurred among the first 10 cases performed by each investigator.

The authors also found that endothelial cell loss remained low. "The current study reanalyzed equivalent yearly rate of change in endothelial cell density over the entire study was -1.7% per year. The stability of the percent of hexagonal cells indicates that the implanted lens does not continue to stress the endothelium," they said.

"Implantation of the Artisan IOL is a safe and effective method for the surgical correction of high myopia in patients who are poor candidates for LASIK," the authors concluded.

Corneal Aberrations Increased, but Visual Quality Unchanged After LASIK
Performing LASIK with the Esiris excimer laser (Schwind eye-tech-solutions, Kleinostheim, Germany) on hyperopic patients with second-order aberrations is safe and effective, according to a study by Jorge L. Alió, MD, PhD, of Spain, and colleagues, published in the Journal of Cataract and Refractive Surgery.

Hyperopic ablation, however, increased corneal higher-order aberrations and reduced the optical quality of the first corneal dioptric surface. Total ocular optics were not affected, the authors wrote.

In the study, LASIK was performed using the Esiris excimer laser in 51 eyes with hyperopia or hyperopic astigmatism. At 6-month follow-up, changes in visual acuity, refraction, and corneal and ocular wavefront aberrations were measured. Ten eyes with LASIK enhancement excluded from follow-up.

Of the 41 eyes, 95.12% had BCVA greater than or equal to preop BCVA at follow-up, and 90.25% had no change or gain of lines of near BCVA. It was also found that 80.50% of eyes were within ±0.50 D of emmetropia.

Statistically significant changes were observed in higher-order and coma-like aberrations, and the primary spherical aberration coefficient Z(4,0) (P<.01).

"Although hyperopic ablation induces a degradation of the optical quality of the cornea, the optical quality of the entire ocular system is not altered significantly, probably due to the compensation effect with the internal optics," the authors said. "This agrees with the fact that no eye lost two or more Snellen lines of BCVA."

Juvenile Cataract Gene Defect Identified
An international team of researchers say they have identified the location and defect in the coding region of the gene that causes autosomal dominant juvenile cataract, according to a news release from the Swiss Federal Institute of Technology (Zurich, Switzerland). The researchers analyzed DNA from members of a large Swiss family, the majority of whom have inherited this type of cataract.

The genetic defect may also lead to a nonpathologic kidney defect called renal glucosuria, the researchers said.

The search for the molecule that is carried by this newly discovered transporter across the cell membrane is under way. Researchers suspect that this genetic defect interferes with homeostatis in the crystalline lens and the kidney. Since the known environmental risk factors for age-related cataract point to physiologic and oxidative damages accumulating over time within the lens, the researchers assume that defects in the transporter may also be a cause of age-related cataract. Understanding the exact function of this transporter may open a venue for nonsurgical treatment of cataract, the researchers said.

Industry Updates Abroad
STAAR Surgical Co., (Monrovia, California), received approval from the State Food and Drug Administration of the People's Republic of China (SFDA) to market the Visian Toric and Visian ICL implantable collamer lens in the country.

According to Market Scope, there are more than 500 million myopes and nearly 50 million hyperopes in China. Additionally, in South Korea, where the population is believed to have a mean myopia rate similar to that of China, phakic implant procedures are estimated to have reached 7% of the refractive surgery market. Data presented at an ophthalmic meeting in Japan showed that STAAR's Visian ICL and toric ICL were used in approximately 60% of those procedures, according to a company news release.

Carl Zeiss Meditec AG (Jena, Germany) also broke into the Asian refractive market, selling the first VisuMax femtosecond laser system in Japan, according to a company news release. The laser has received marketing clearance in both Korea and Canada, following CE certification and FDA approval.

LASIK Results With Schwind Amaris Accurate at 6 Months
Myopic LASIK with the Amaris laser (Schwind-eye-tech-solutions) demonstrated excellent visual acuity results at 6 months, according to a Schwind news release. Of 358 eyes treated with the Schwind Amaris laser during the multicenter study, 65% achieved postoperative UCVA of 20/16 or better. In 98% of eyes, UCVA was 20/20 or greater. Additionally, at 6-months postoperatively 96% of treated eyes were within ±0.50 D of the target refraction.

Fifty-five percent of eyes undergoing aberration-free treatments with the Schwind Amaris gained one or more lines of Snellen acuity after 6 months. With this treatment, the induction of higher-order aberrations is minimized compared with nonaspheric treatments, according to the release. The total root-mean-square of postoperative higher-order aberrations rose an average of 0.07 µm. This also resulted in higher postoperative contrast sensitivity for patients, the release said.

At 1-day follow up, eyes attained the same UCVA as the preoperative BCVA, on average. At 6-months postoperatively, the postoperative UCVA increased to 20/16, on average.

– Compiled by Leah D. Farr, News and Industry Editor