December 01, 2004
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Zeiss intends to add LDT’s GDx to its diagnostic arsenal

With the announcement of its intention to purchase Laser Diagnostic Technologies, Zeiss hopes it will have complementary glaucoma diagnostic platforms.

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NEW ORLEANS – Days before the American Academy of Ophthalmology meeting, Carl Zeiss Meditec announced its intention to purchase Laser Diagnostic Technologies. If the deal is completed, a Zeiss official said, it is hoped that the purchase of LDT’s GDx glaucoma diagnostic technology will add to the strength and depth of the Zeiss glaucoma diagnostic line.

“With no arrogance, in functional and structural evaluation and management of glaucoma, we have the portfolio from beginning to end,” said Jim Taylor, president and chief executive officer of Carl Zeiss Meditec Inc. He spoke to Ocular Surgery News at the AAO meeting regarding the strategy behind his company’s pending addition of LDT’s GDx technology to its lineup.

For functional glaucoma testing, Zeiss offers a complete line of autoperimetry devices including the Humphrey FDT Visual Field Instrument and the Humphrey Field Analyzer II, which was upgraded last year with progression analysis software and this year with the Swedish Interactive Test Algorithm for Short Wavelength Automated Perimetry (SITA-SWAP). On the structural side, the company manufactures the Stratus OCT diagnostic device for optical coherence tomography of the posterior segment.

“We do believe that the retinal nerve fiber layer is where the action is in terms of change and progression of glaucoma and detection of glaucoma. Both these devices [Stratus OCT and GDx] look at the nerve fiber layer but look at it differently,” Mr. Taylor said. “It is possible that in certain patients OCT will pick up things earlier than GDx, and in other patients GDx may pick it up earlier.”

Zeiss is not looking at the two options — GDx and Stratus OCT — as a “low-cost/high-cost alternative,” Mr. Taylor said. Rather, he noted, the ophthalmologist can make a choice based upon the needs of his or her own practice.

Aside from the financial and business impact the acquisition would have, Mr. Taylor said, Zeiss looked at the addition of LDT’s technology from the clinician’s perspective.

“We had to decide from a clinical standpoint whether the products were complementary as opposed to competitive; whether together they were better in our portfolio than individually,” Mr. Taylor said. “I think we have convinced ourselves of that.”

Zeiss will be looking at the possibility of combining the structural and functional test results in the attempt to provide more valuable diagnostics, according to Mr. Taylor. “Not making them necessarily the same product, but taking a look at the outputs and figuring out how they can be used together for better clarity in the overall diagnosis,” he said.

Zeiss will continue to invest in both technologies because both have a place in glaucoma diagnosis, Mr. Taylor said. “Both need investment and evolution, and we are excited about doing it,” he said.

The purchase of LDT by Zeiss is expected to close by the end of 2004, providing shareholders for both groups approve, according to a joint press release from the two companies. Financial terms were not disclosed at the time of the announcement.

Zeiss introduces two devices

In other news, Zeiss introduced two devices here at the meeting, an anterior segment imaging and biometry device and a perimeter for use in age-related macular degeneration.

The Visante OCT customizes the Zeiss optical coherence tomography technology for the anterior segment by introducing a long-wavelength light source with a faster imaging speed, according to information from the company.

Prof. Georges Baikoff has used the machine extensively in the field of phakic IOLs, company literature noted. It allows the clinician to preoperatively measure the patient’s anterior segment anatomy, including internal angle-to-angle diameters, anterior chamber depth and crystalline lens location.

The Visante is currently in development and not available in the United States, the company said.

The PreView Preferential Hyperacuity Perimeter (PHP) is designed not for glaucoma, but retinal diagnosis, the company said.

The PreView PHP identifies elevations in the retinal pigment epithelium that are consistent with findings present in the macula during conversion from intermediate to advanced wet AMD.

“With this system in a clinician’s arsenal, practitioners are more likely to be able to intervene with treatment at an earlier stage of advanced AMD than might have been possible without the results from the PHP,” said Neil M. Bressler, MD.

Dr. Bressler said the test’s sensitivity was shown to be 82% and the specificity 88% in a study including 122 subjects: 57 with intermediate AMD with at least one large drusen and 65 with CNV diagnosed within the past 60 days.

B&L launches aspheric IOL

An IOL with aspheric optics on both its anterior and posterior surfaces was introduced here by Bausch & Lomb.

B&L representatives said the SofPort AO lens will be available to surgeons immediately. Except for its aspheric optics, the new foldable silicone IOL has the same design as its predecessor, the company’s SofPort SE lens.

Louis D. Nichamin, MD, who said he has implanted about 35 of the new IOLs, said the double-aspheric design “is more forgiving” for surgeons than other aspheric IOLs such as the Tecnis from Advanced Medical Optics. He said the Tecnis, which induces negative spherical aberration to counter the naturally occurring positive spherical aberration in the cornea, can create higher-order aberrations if it is decentered, he said.

The SofPort AO is designed to have no spherical aberration.

“Until we have the ability to create customized IOLs to account for all the errors in the patient’s visual system, we need a lens that is neutral, that will not add to patients’ existing higher-order aberrations,” Dr. Nichamin said.

Heidelberg cornea module

The Rostock Cornea Module, a laser microscope for corneal imaging, received U.S. regulatory clearance, according to manufacturer Heidelberg Engineering. This new component for the company’s confocal laser microscope was on display here at the meeting.

The Rostock device uses laser scanning technology to directly image a patient’s cornea. The module, which can be connected directly to the HRT II, the company’s laser imaging instrument for glaucoma, displays magnified images of the internal structures of the cornea, allowing the clinician to view the cell layers and individual cells in real time.

“The images generated by the confocal laser microscope are the clearest corneal images now available for eye care practitioners,” said Travis Lindsay, chief operating officer for Heidelberg.

The company said it expects the microscope to be particularly useful for recognizing parasitic infections, an increasing problem for long-term contact lens wearers.

Massie launches adult camera

A device for imaging the anterior and posterior segments of adult patients, with applications for the detection and monitoring of primary open-angle glaucoma, was launched here by Massie Laboratories Inc.

Administering an examination with the ADIS-9000 takes less than 5 minutes, compared with standard imaging technologies that can take almost 30 minutes, said Mike Napier, chief business officer at Massie, the device’s maker. Capturing these types of images was formerly possible only in a few institutions and required a skilled technician, he said.

The ADIS-9000 offers high-resolution, hand-held versatility for a number of ophthalmic subspecialties in a private practice setting, according to a company press release. The learning curve is short, the release noted.

The camera has the potential to benefit large multispecialty group practices, as well as cornea, retinal and glaucoma specialists, according to the release.

“That’s what we do. Provide to clinicians innovative technology and then step back and allow them to incorporate it effectively into their practice,” said Bert Massie, PhD, founder, chairman and chief executive of Massie Laboratories, in an interview with Ocular Surgery News.

Massie Laboratories is also the developer and manufacturer of the RetCam II, which is widely used for retinal imaging in pediatric patients.

WaveLight ‘significant’ in first year in U.S. market

In its first year in the U.S. market, WaveLight Inc. achieved a 20% share of all new U.S. refractive laser sales, according to independent market analyst Market Scope. WaveLight announced the finding in a press release at the meeting.

“Despite a late start in the U.S. market, WaveLight has captured a significant share of new laser sales during the past year,” said David R. Harmon, president of Market Scope, in the press release from WaveLight.

The WaveLight Allegretto Wave excimer laser system gained FDA approval in October 2003.

The company also announced that it received an investigational device exemption from the FDA in September to conduct further U.S. clinical studies with its laser, including expanded treatment ranges and wavefront-guided LASIK.

WaveLight has been the leader in new refractive laser sales internationally for 2 years in a row, the company said.

New vision testers

Three vision testers, two for adults and one for children, were introduced here by the Clear Vision Foundation.

The Central Vision Screener (CVS) is designed for use in the exam lane for rapid screening of central vision, replacing the need for a paper or projected acuity chart. The Multi-axis Vision Evaluation System (MAVES) measures multiple components of central vision through a central 20° visual field mapping device. Kidsight is an interactive video game that measures vision in 3- to 8-year-olds, according to the Clear Vision Foundation, which developed all the tests.

The CVS measures vision under six stressful but routinely encountered conditions of illumination and contrast. These include high-contrast, dim background; high-contrast, glare background; and blue on yellow. The automated test instructs the patient to select from a button pad the direction that the letter “C” is facing in a range of backgrounds. The central vision test takes about 1.5 minutes to run on both eyes.