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Visante anterior chamber OCT debuts at AAO
Product introductions, consolidations and positive financial news highlight this roundup of business news from the AAO meeting.
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CHICAGO — Carl Zeiss Meditec Inc. introduced a device for noncontact anterior segment imaging during the American Academy of Ophthalmology meeting here. The Visante OCT allows high-resolution ocular coherence tomography imaging of anterior segment structures including the cornea, iris, angle and crystalline lens.
The Visante OCT can accurately measure corneal thickness without the need for immersion or anesthesia, according to information from Zeiss. The device can be used for full-thickness pachymetry as well as measurement of flap and stromal bed thickness immediately after LASIK, according to the company.
The device can also measure anterior chamber depth, anterior chamber angles and the angle-to-angle distance, the company said. In addition, IOLs and other implants in the anterior segment can be imaged and evaluated postoperatively.
The Visante OCT can measure LASIK flaps. Image: Vukich JA |
At a CME symposium sponsored by SLACK Incorporated and supported by an unrestricted grant from Zeiss, David Huang, MD, PhD, spoke about the physical principles of the Visante OCT. He said the device uses a laser wavelength of 1.3 µm, rather than the 0.8 µm wavelength used in posterior segment OCT imaging. This wavelength increases water absorption and decreases retinal exposure, allowing clear imaging of the anterior segment structures, Dr. Huang said.
At the same symposium, John A. Vukich, MD, reviewed the data from the U.S. clinical trial that led to Food and Drug Administration 510(k) approval of the device in October. In that multicenter trial, pachymetry measurements with the Visante were compared to those with a DGH ultrasound pachymeter and with the Bausch & Lomb Orbscan.
In 381 eyes, the Visante measured central corneal thickness consistently thinner than ultrasound and Orbscan, Dr. Vukich said, but the measurements correlated well. The researchers concluded that the Visante measurements were more precise than ultrasound and Orbscan, he said.
The ability of the Visante to detect LASIK flaps was also evaluated in the trial. The Visante had high sensitivity and specificity in detecting LASIK flaps, and is capable of producing images that are of use to the LASIK surgeon, he said.
IntraLase market penetration increased
More than 500,000 blade-free LASIK vision correction procedures have been performed since regulatory approval of the IntraLase, according to a spokesman for the company.
During a breakfast meeting before the AAO meeting, Robert J. Palmisano, president and chief executive officer of IntraLase, said the company attributes the milestone “to the technology of the IntraLase femtosecond laser,” which has been on the market for 4 years.
“Our theme is better medicine, better business,” Mr. Palmisano said.
There has been a 75% increase in LASIK procedures using the IntraLase method in the past year and an overall shift toward blade-free LASIK as a procedure of choice, he said.
Outside the United States, IntraLase will begin shipping its lasers to South American in early 2006 and recently received Chinese regulatory approval, Mr. Palmisano said.
Nidek combines U.S. operations
Nidek Co. Ltd. announced in a press release that it is combining Nidek Technologies America with Nidek Inc.
The parent company, based in Gamagori, Japan, announced in a press release distributed at the American Academy of Ophthalmology that it will merge and consolidate all business activities by its two wholly owned subsidiaries in the U.S. market effective April 1, 2006.
“This is an exciting time fore Nidek’s business operations in the U.S. as we continue our strong focus on harnessing business and product distribution synergies in the U.S.,” Hideo Ozawa, company founder and president, stated in the press release. “Bringing the two groups together will allow Nidek to offer one source for its advanced diagnostics and surgical ophthalmic instrumentation to the vision care professional in the U.S.”
Product marketing, sales, service and customer support will be transferred to Nidek’s Fremont, Calif., location, according to Philip M. Buscemi, OD, vice president and general manager of Nidek Technologies America.
Redesigned phaco system increases cutting power
A redesigned version of Advanced Medical Optics’ WhiteStar phacoemulsification system was introduced at the AAO meeting.
AMO’s WhiteStar Ice technology for its Sovereign phacoemulsification system is designed to allow surgeons to increase cutting power without increasing energy, the company said in a press release.
“The use of fluidics to complement ultrasound cataract extraction marks a paradigm shift that could allow surgeons to develop better techniques to improve patient outcomes,” stated Paul Rockley, AMO’s vice president of worldwide marketing for cataract equipment, in the release.
The user interface technology was improved to allow surgeons to customize the Ice pulse for different techniques, according to AMO. The technology also features chamber stabilization environment technology to enable optimized use of fluidics while reducing surge on occlusion break, the release said.
“Corneal clarity with WhiteStar Ice technology is the most ideal I have ever seen,” said Donald Nixon, MD, in the press release. “With WhiteStar Ice technology, we were able to achieve a more efficient removal of the cataract and still establish the same corneal clarity. We’ve gotten more and lost nothing in the exchange.”
New cataract/IOL and vitamin products from Alcon
Alcon introduced a number of new products to the U.S. ophthalmic market during the AAO meeting.
The AcrySof IQ is an aspheric IOL with a thinner central optic than other aspheric IOLs available, according to the manufacturer. Previously known as the AcrySof HOA, the IQ is a one-piece acrylic IOL designed to reduce spherical aberrations and provide improved image quality, according to Alcon. The AcrySof IQ has the same blue-light-filtering properties as the Alcon Natural IOL.
Additionally, the company announced that its presbyopia-correcting IOL, the AcrySof Restor, is now available with the same blue-light filtering chromophore. The AcrySof Restor is composed of the same biocompatible materials as the original AcrySof lens, the company noted.
The company also launched the OZil torsional handpiece for oscillatory phacoemulsification on the Alcon Infiniti Vision System.
The OZiL uses ultrasonic oscillations at 32 kHz to efficiently remove lenses of all densities, according to the company. It also reduces repulsion for increased nuclear followability, maximizing surgical control with no change to existing technique, according to information provided by Alcon.
For more on the clinical capabilities of the OZiL handpiece, see the remarks of Takayuki Akahoshi, MD, on page 11 in the main AAO article in this issue.
Alcon also introduced an Age-Related Eye Disease Study (AREDS)-based MultiVitamin containing all the essential ingredients patients needed for both eye and body nutrition, according to the company.
The Alcon ICAPS MV Eye Vitamin Supplement formula matches the doses of vitamins and minerals that were used in the National Eye Institute-sponsored study, according to information supplied by the company.
WaveLight introduces Pentacam-based topographer
WaveLight Inc. introduced a second corneal topography system that can be used with its Allegretto Wave excimer laser. Through a licensing agreement with Oculus GmbH, WaveLight will distribute the Oculus Pentacam under the brand name Oculyzer, according to a press release from WaveLight.
The Oculyzer can be integrated with the Allegretto Wave laser through the OcuLink software package, according to WaveLight. The Oculyzer uses a Scheimpflug camera to provide five measurements of the anterior segment, including measurement of the central cornea. The Oculyzer joins the Topolyzer, also licensed from Oculus, as a second topography system that can be integrated with the Allegretto Wave.
WaveLight also announced during the AAO meeting that it has sold its 100th Allegretto Wave laser in the United States. Following premarket approval in 2003, WaveLight gained 20% of U.S. refractive laser sales in its first year, and from 2004 to 2005 its sales have nearly doubled, the company announced in a press release.
The day before the AAO meeting began, the German parent company of WaveLight Inc. released its financial report for the year ending July 31. WaveLight Laser Technologie AG reported revenues for the year of $98 million, a 30% increase from the previous year, according to a press release.
Solx receives IDE for trial of gold shunt
Solx Inc. announced on the last day of the AAO meeting that it had received approval from the Food and Drug Administration to begin U.S. clinical investigation of its DeepLight Gold Micro-Shunt implant for treatment of glaucoma. The randomized, multicenter study will evaluate the safety and efficacy of the device for lowering IOP in patients with primary open-angle glaucoma, according to a press release from Solx.
Multicenter trials of the device in Spain and Israel with up to 2 years of follow-up in 70 eyes have shown “excellent clinical results,” according to the press release.
The IDE approval follows CE Mark approval from European Union regulators for the device, which was received earlier in the week, according to the company.
At a press briefing held during the meeting, Robert Kershner, MD, described how the Gold Micro-Shunt works as part of the DeepLight Glaucoma Treatment System. The 0.5-mm wide shunt is implanted in the suprachoroidal space, Dr. Kershner said, with one end in the anterior chamber to facilitate aqueous outflow. If more outflow is desired, the 790-nm wavelength DeepLight TiSa laser can be used to open more channels in the implant.
Alternatively, the laser by itself can be used for trabeculoplasty procedures; its wavelength allows deeper tissue penetration than other lasers used in glaucoma procedures without causing thermal damage to the trabecular meshwork, according to Solx.
Lumenis introduces Selecta line
Lumenis debuted its Selecta family of lasers and other new products to the U.S. ophthalmic market during the meeting. The company recently received U.S. marketing approval for the devices, Lumenis announced in a press release.
The lasers introduced at the meeting include the Selecta 1064-nm Nd:YAG base platform, designed for anterior segment procedures such as elimination of posterior capsular opacification and creation of peripheral iridotomies. The Selecta Duo adds to the base model Nd:YAG with a 532-nm photocoagulator for posterior segment applications. The Selecta Duet upgrades the base model with a Q-switched, frequency-doubled 532-nm laser for selective laser trabeculoplasty. The Selecta Trio combines the Nd:YAG, diode-pumped solid-state 532-nm photocoagulator and Q-switched, frequency-doubled 532 nm laser.
The Novus 3000 is a “fully-integrated and powerful 532-nm operating room photocoagulator with reliable diode-pumped solid state technology that uses both a touch screen and remote control,” according to Lumenis.
Other product approvals include the Lumenis 1000 Integrated Slit Lamp, the Lumenis 950 Slit Lamp and the Coaxial Multicolor Laser Indirect Ophthalmoscope.
National Eye Bank Center will make donor eye transporting more efficient
The recently opened National Eye Bank Center operated by Tissue Banks International will more effectively evaluate, test and distribute donated eye tissue, according to the organization’s president.
Gerald J. Cole, president and CEO of Tissue Banks International, said the group has selected Memphis, Tenn., as the site for the center because of its proximity to the FedEx “hub” in Memphis.
“We can take advantage of FedEx’s worldwide hub and get tissue evaluated and sent out that same day” for transplantation and research, Mr. Cole said here in an interview with Ocular Surgery News.
Mr. Cole said that before the new center opened, donor corneas were tested and distributed through community-based donor programs throughout the country.
“We still have eye banks,” he said, but he noted that the new facility has different and more state-of-the art equipment to test the donor tissue.
For example, he said, IntraLase Corp. and TBI have agreed to use an IntraLase FS laser for preparation of corneal allografts for transplant. According to a press release issued jointly by TBI and IntraLase, “initial clinical work suggests that allografts prepared with IntraLase’s femtosecond laser are stronger than those prepared with traditional penetrating keratoplasty, with less induction of astigmatism.”