CRSToday Europe News — April 2007

Endophthalmitis Risk, Incision Type Examined
The rate and etiology of endophthalmitis after cataract surgery was highest in cases with clear corneal incisions or temporal wounds, according to a study published in Ophthalmology.

Swedish investigators found the overall rate of postoperative endophthalmitis to be approximately 0.048% (109 of 225,471 cases) in the 2-year study. Instances of postoperative endophthalmitis with clear corneal and sclerocorneal incisions was found to be 0.053% and 0.036%, respectively. Additionally, the endophthalmitis rate for superior and temporal incisions was 0.040% and 0.055%, respectively.

Investigators examined patient history and operation technique with a special emphasis on incision type and location; use of injector for the IOL implantation; kind of prophylaxis; and the presence of preoperative communication between the anterior chamber and vitreous. Communication between the anterior segment and vitreous was also found to be a highly significant independent risk factor for endophthalmitis. Still, authors concluded the widespread use of prophylactic intracameral cefuroxime may be tied to the generally low endophthalmitis rates in Sweden.

CATz Topographic Ablation Positively Impacts Vision
For a majority of patients with irregular corneal astigmatism from a previous refractive surgery, customized aspheric treatment zone (CATz) topography-guided ablation improves quality of vision and systems.

According to data from 32 eyes (28 patients), UCVA and BSCVA increased by more than 2 lines after CATz ablation in 17 and 11 eyes, and decreased in four and two eyes, respectively, according to the study published in Journal of Refractive Surgery. Additionally, higher-order aberrations were decreased in 16 eyes, and increased in one eye. Seven eyes required further enhancement for residual refractive errors.

CATz ablation was performed using PRK or LASIK, with a Nidek EC-5000 excimer laser (Gamagori, Japan). All measured eyes had decentered ablations, small optical zones, decreased BSCVA, and asymmetrical astigmatism. After CATz ablation, 13 patients (15 eyes) were satisfied with the outcome, six patients (seven eyes) stated that the outcome was lower than expected, and four patients (four eyes) stated they were dissatisfied. Authors concluded that residual or induced refractive errors may need to be corrected with a second operation after CATz.

Cell Count Examined With Viscoelastics
The endothelial cell count was higher after cataract surgery when a dispersive hyaluronate viscoelastic was used versus a cohesive viscoelastic, according to a study published in Acta Ophthalmologica Scadinavica.

Allan Storr-Paulsen, MD, and colleagues from Frederiksburg University Hospital, in Denmark, compared hydroxypropyl (Celoftal; Alcon Laboratories, Inc., Fort Worth, Texas), sodium hyaluronate (Vitrax; Advanced Medical Optics, Inc., Santa Ana, California) and sodium hyaluronate (Healon; Advanced Medical Optics, Inc.) for any effect on endothelial cell count after in-the-bag phacoemulsification and IOL implantation.

According to the report, three groups of 20 eyes showed equally significant improvements in visual acuity and a decrease in endothelial cell count, at 3-months postop. Cell count decreased by 6.97% in patients with Vitrax, while it decreased 18.03% and 18.46% when surgeons used Celoftal and Healon, respectively. A dispersive ophthalmic viscoelastic device could protect the endothelial cells, while suppressing the formation of free radials, authors concluded.

"This may be the reason for the superior protective effect on the corneal endothelial cells of Vitrax compared with Celoftal and Healon," they wrote.

Lens Exchange Due to Incorrect Corneal Power
Incorrect corneal power determination was the most frequent reason for IOL exchange, according to a retrospective review published in Ophthalmology. The study, which evaluated patients who had IOL exchange for unexpected postoperative refractive errors, determined the sources of the errors and derived an empiric approach to estimating the power for IOL exchange.

Of the 22 eyes that underwent in-the-bag IOL exchange, investigators found keratometry errors in five cases (23%), incorrect axial length in three cases (14%), and wrong IOL implanted in three cases.

After IOL exchange, 18 (82%) of eyes were within 0.50 D and 19 eyes (86%) were within 1.00 D of emmetropia. UCVA was 20/40 of better in 82% of eyes, and BSCVA was 20/40 or better in 95% of eyes (P=.002).

Award Granted to Carl Zeiss
Carl Zeiss Meditec AG (Jena, Germany) won the Innovation Award of German Industry in the large company category. The prize honored the development of leading edge optics, which enables fabrication of latest generation microchips. They also received the Decade Award as the finalist with the largest number of submitted innovations over the past 10 years.

"The Innovation Award and, in particular, the Decade Award for sustainability confirm that we are on the right track with our strategic initiatives in the field of innovation. Successful innovations are the foundation of our sustained growth, and this safeguards jobs in Germany," said Carl Zeiss President and CEO, Dieter Kurz, MD, who is also responsible for research and development. A total of 238 submissions were received for this year's Innovations Award of Germany Industry. Among the companies participating, Carl Zeiss was successful with its innovation—Innovation Optics-Water Revolutionizes Chip Fabrication—from its subsidiary, Carl Zeiss SMT AG.

Ellex Medical Lasers Acquired Diagnostic Ultrasound System
Ophthalmic laser systems manufacturer Ellex Medical Lasers, Ltd. (Adelaide, Australia) acquired Innovative Imaging, Inc., (Sacramento, California) for $1 million. Innovative Imagining, Inc., designs and manufactures ophthalmic ultrasound systems, with more than 1,300 systems worldwide.

Under the terms of the agreement, Ellex will also make annual payments for 3 years, based on the performance of the business. The company's current headquarters will remain and continue to operate as an engineering and manufacturing center focused on the I3 System sales and service support network.

"The acquisition of Innovative Imaging is in keeping with Ellex's stated strategy to grow by focusing on direct marketing of Ellex products to ophthalmologists around the world," said Ellex CEO, Peter Falzon. "Innovative Imaging provides an essential technology to Ellex's target customers, and the products and technology fit well into Ellex's manufacturing, sales, marketing, and service capabilities. We expect to translate into significant benefit of synergy over time."

Alcon Warns of Central Islands
Alcon Laboratories, Inc., issued a safety alert for the Ladar 6000 excimer laser.

Last month, Alcon directed surgeons to discontinue using the laser for CustomCornea myopia procedures, after seven surgical centers reported an increased presence of topographically-observed central islands in myopic patients undergoing this procedure, said Alcon spokesperson, Kathleen Golden, in a telephone interview with Cataract and Refractive Surgery Today Europe. No safety alerts were issued for other procedures performed with the Ladar 6000, Ms. Golden said.

The Ladar 6000 first received US Food and Drug Administration (FDA) approval in May 2006.

Alcon also alerted the US FDA of the central islands, and has submitted a Pre-Market Approval supplement, which proposed that the issue could be resolved by reversing the direction of the ablation pattern and resetting the repetition rate to 60 Hz.

Approximately 100 units have been affected by this alert, including 12 in Spain, Portugal, Italy, and Asia, Ms. Golden said.

"We are currently asking physicians to provide any information they have that might help further our investigation," Ms. Golden said. "We will continue to work diligently with the FDA to resolve the issue."

FDA Approval Not Likely For Visian ICL in 2007
The FDA approval for the Visian Toric ICL (TICL) is unlikely for 2007, according to a news release from STAAR Surgical (Monrovia, California). FDA staff indicated that STAAR's amended application would be submitted to the Ophthalmic Devices Panel of the Center for Devices and Radiological Health for further evaluation, because the TICL is the first FDA-reviewed toric phakic IOL.

In November 2006, the FDA requested additional data on transitory rises in the rate of excessive ICL vaulting, which STAAR Surgical reported last year.

"We had hoped for faster review, but based on this feedback, we believe that approval of the TICL will be unlikely in 2007," said David Bailey, president and CEO of STAAR Surgical, in a news release.

The Visian TICL has already received approval for use in Europe and some Asian nations, according to a company news release.

Risk of Error Examined
Cutting junior doctors' working hours and giving them more rest breaks will not, by itself, reduce fatigue or the attendant risk of error, a study published in Occupational and Environmental Medicine concluded.

An anonymous questionnaire on work patterns, sleepiness, and errors related to tiredness was sent to more than 2,000 junior doctors who were working 40 or more hours a week in accordance with schedules designed to cut weekly working hours, ensure adequate rest breaks, and reduce the associated risk of errors. Almost 1,400 responses were received, and each participant was given a fatigue risk score by combining 10 aspects of work patterns and sleep in the preceding week.

Approximately 30% of respondents were classified as "excessively sleepy," according to a recognized sleepiness scale. One in four said that since becoming a doctor, they had fallen asleep at the wheel of their car while driving home. Two-thirds said they had come close to falling asleep at the wheel in the previous 12 months, and one in five said that this had happened on at least five occasions. The doctors were twice as likely as the general population to score as excessively sleepy and more than twice as likely to report nearly falling asleep at the wheel as British male drivers.

Two-thirds of doctors surveyed said that they had made a mistake associated with fatigue at some point in their careers, while more than four of 10 said that this had happened in the preceding 6 months.

Night shifts and unscheduled changes to rosters were more consistently linked to sleepiness and errors than the total number of hours worked, after taking account of age and other factors. Conversely, regular access to supervision reduced the likelihood of sleepiness and errors, irrespective of the total hours worked. "We conclude that long work hours are not the only aspect of work patterns that need to be managed to reduce sleepiness and fatigue related clinical errors among junior doctors," the authors wrote. "The findings support the view that a more comprehensive risk management approach is needed to reduce doctors' sleepiness and improve patient safety."

Doctor/Author Received Charles Kelman Award
Robert H. Osher, MD, was the recent recipient of the Charles Kelman Award at the 11th European Society of Cataract and Refractive Surgeons (ESCRS) Winter Refractive Surgery Annual Meeting, in Athens.

Anne Kelman, the widow of Charles Kelman, presented the award, which was given to Dr. Osher for his outstanding contribution to the field of cataract surgery. Dr. Osher is a Professor of Ophthalmology at the University of Cincinnati, and the Medical Director Emeritus of the Cincinnati Eye Institute, which he founded.

Dr. Osher was recognized as a leader in cataract surgery—designing many contemporary IOLs, instruments, and new techniques, as well as producing prize-winning surgical videos. He has also authored several children's books.

A special book signing by Dr. Osher to benefit the American Society for Cataract and Refractive Surgery (ASCRS) Foundation will be held in the exhibition hall at the ASCRS meeting in San Diego, April 28 to 30.

"I enjoy using my stories to raise money for good causes, and I know the ASCRS Foundation is very worthwhile," Dr. Osher said in an interview with Cataract & Refractive Surgery Today, CRST Europe's sister publication. "I am thrilled to be able to donate these books and personally sign them ... during the ASCRS meeting."