BBI Contributing Editor
ORLANDO, Florida — A number of ophthalmic device manufacturers used the 2002 annual meeting of the American Academy of Ophthalmology (AAO; San Francisco, California), held at the sprawling Orange County Convention Center in October, as a forum to introduce their newest product lines.
The most notable market leader at the AAO this year was Lumenis (Santa Clara, California), which showcased four new lasers — the Novus TTX, an 810-nm solid-state infrared diode photocoagulator; the Novus Spectra, a 532-nm green diode-pumped solid state photocoagulation laser; the Selecta Duet, a combination laser system integrating Lumenis' patented Selective Laser Trabeculoplasty (SLT) platform with advanced photodisruptor Nd:YAG laser technology; and the NovusVaria multicolor photocoagulation laser system.
The Novus TTX combines the power of an 810-nm infrared laser with Lumenis' exclusive and adaptable user interface in a system weighing in at only seven pounds. It features four energy delivery modalities (Quad Mode) — normal-pulse, CW, micro-pulse and timed — that allow the user precise control over the amount of exposure released during each customized laser treatment. Using Normal Mode for transpupillary photocoagulation, surgeons can vary pulse duration between 10 milliseconds (ms) and 10 seconds and interval time for repeat pulses from 10 ms to one second. In CW Mode, the single exposure time can extend up to 60 minutes. Using the micropulse (burst) mode for treating diabetic macular edema and diabetic retinopathy, pulse duration can be varied over the range of 50 ms to 100 ms and pulse interval time from 50 ms to 100 ms. Timed exposure mode allows single pulsing over a period of one second to 60 minutes when treating ocular melanomas.
Other new advanced features are found on the Novus TTx, including a distal feedback monitor that verifies the actual light energy delivered during treatment; a direct coupled spot size designed to automatically adjust laser power to the physician's selected spot size and thereby deliver the desired laser power density to the treatment area; contact lens adjustment; and a user interface touch screen permitting immediate modification and treatment customization.
The unique laser combination found in the Selecta Duet provides anterior segment surgeons a cost-effective, convenient, single-platform solution for treating glaucoma and secondary cataracts. Its 532-nm glaucoma laser system is approved for performing SLT plus a range of other glaucoma procedures. The device also incorporates the Lumenis 1064-nm infrared Nd:YAG laser for performing posterior capsulotomy.
Both the Novus Varia and Novus Spectra carry FDA approval for marketing in the treatment of the following retinal disorders: age-related macular degeneration, diabetic retinopathy, diabetic macular edema, retinopathy of prematurity, and retinal vein occlusions. The Spectra is a compact, portable device, weighing less than 18 pounds. Based on semiconductor technology, it offers high energy delivery potential, up to 2.5 watts of power, without needs for external hook-ups, frequent maintenance or special cooling that accompany argon-based laser systems.
The Novus Varia is an energy-efficient, solid-state, multi-wavelength laser that also is able to operate on any standard electrical outlet. Like the Spectra, it too is devoid of the regular maintenance and special cooling requirements of competing multicolor photocoagulation lasers that are based on krypton or argon dye. Using the convenient color touch screen of the Novus Varia, operators can instantly switch the beam between green, yellow and red light as well as change power settings.
WaveLight Laser Technologie (Erlangen, Germany), a strategic partner with Lumenis in the refractive market, previewed a prototype refractive surgery system integrating excimer laser and diagnostic technologies. This laser features an extremely fast, 500-Hz pulse frequency with an optimized 3-D eyetracker that records both eye rotation and iris structure. The system also includes a pachymeter allowing for interoperative measurements of corneal thickness plus technology for monitoring the fluorescence behavior of the cornea to afford better control of ablation depth based on detection of blood or tear fluid in the stroma bed. Although it will take some time to finalize the design and commercialize this system, industry observers view it as a prototype for what may be considered the ultimate refractive surgery system. Lumenis plans to begin marketing the WaveLight Allegretto refractive laser system in the U.S. pending FDA approval, which is expected in 2003.
Iridex (Mountain View, California) also introduced a combination system for use in glaucoma and retinal photocoagulation procedures. Known as the OcuLight Symphony, this system features the OcuLight GLx 532-nm, diode-pumped, frequency doubled, solid-state laser with the OcuLight SLx 810-nm, diode solid-state laser and allows delivery of 532-nm, 810-nm and large spot 810-nm treatment. The control consoles for these two lasers are found on a single custom cart that can be readily moved from room to room. Purchasers have the option of buying a system with a dual fiber slit-lamp adapter that allows 532-nm and large spot 810-nm treatments or a multifiber adapter permitting standard 810-nm treatment as well.
Carl Zeiss Meditec unveiled its new MEL 80 excimer laser, which is described as being small, fast, precise and mobile. It features an ultra-fast eyetracker that operates without the need for a limbus ring or dilation, along with a 0.7-mm spot with a Gaussian beam profile to produce precise, smooth ablations. Using the MEL 80, ablation times are markedly shortened relative to its predecessor, the MEL 70 GScan, and the extremely small footprint and wheel-mount assembly of the device make for easy maneuverability.
WaveFront Sciences (Albuquerque, New Mexico) introduced an upgraded version of its Complete Ophthalmic Analysis System (COAS). Known as the Complete Ophthalmic Analysis System-High Definition (COAS-HD), it combines the performance and dynamic range of the original COAS Shack-Hartmann wavefront analyzer with fourfold higher sensor spatial resolution. The COAS-HD obtains about 3500 measurements on an eye with a 7-mm pupil, and with its extremely high resolution is expected to be an asset for imaging eyes with a variety of pathologies affecting optical performance as well as for enabling technology for higher resolution customized refractive procedures.
Alcon (Fort Worth, Texas) said that the FDA approved its customized wavefront-guided laser eye surgery application, making it the first company to receive FDA approval for customized LASIK surgery using a wavefront measurement device and an excimer laser. Using the LADARVision 4000 excimer laser and the LADARWave wavefront measuring device, Alcon brings an integrated system approach to customized laser eye surgery. High and low order aberrations unique to each patient's eye are captured by the LADARWave aberrometer. This information is then transferred to the LADARVision 4000 laser, where it is electronically registered and computer matched to create the precision ablation required in customized laser eye surgery.
"Wavefront-guided customized laser surgery has the potential to improve visual acuity and enhance overall vision quality as compared to today's conventional LASIK. Treating optical aberrations, which impact low-contrast visual activities such as night driving, will improve the patient's quality of vision," said Dr. Stephen Brint, associate professor of ophthalmology at Tulane University School of Medicine (New Orleans, Louisiana), one of the five surgeons participating in the clinical investigations.
Clinical trials are ongoing for the treatment of myopic astigmatism, hyperopia with and without astigmatism and other ocular irregularities.
Biolitec (Bonn, Germany/East Longmeadow, Massachusetts) showed one of the most comprehensive ranges of solid state, diode-based retinal lasers, accessories and endo-probes in the industry. The complete range includes a 532nm green, 689nm PDT laser for age-related macular degeneration treatment and an 810nm for transpupilliary thermo therapy and transcleral applications.
Most excitement centered around the launch of a new, 670nm Red photocoagulator, which closely resembles the krypton red laser in terms of beam tissue interaction and transmission characteristics, coupled with all of the economic and reliability benefits associated with solid state diode based technology. The laser was developed by Biolitec in co-operation with Dr. P. Lanzetto and Professor. F. Bandello of the University of Udine (Udine, Italy) and Professor Menchini from Florence, Italy.
Refractec (Irvine, California) unveiled post-launch results for conductive keratoplasty (CK), the first non-laser procedure for treating farsightedness (hyperopia) in people over age 40. A total of 3,860 CK procedures were performed through the first week of October following CK's approval by the FDA in mid-April. Some 54 U.S. physicians were trained and performed the procedure during CK's introductory period. The three-minute CK procedure uses radio waves instead of a laser or scalpel to treat farsightedness; there is no cutting and no removal of tissue. CK is performed in-office with only topical (eye drop) anesthesia.
Following FDA approval, Refractec orchestrated a limited rollout of CK among U.S. ophthalmologists to allow for close monitoring of patient results and to ensure the successful implementation of this new technology by physicians. The company's decision to limit the number of physicians offering the CK procedure proved successful. "The demand for CK has grown at a very rapid pace, compared to past vision correction procedures," said Mitchell Campbell, president and CEO. "In under six months, CK physicians have averaged 15 procedures per month — a milestone which took physicians performing photorefractive keratectomy (PRK) laser surgery more than a year to achieve after that procedure was introduced in 1995."
The results for CK and corresponding demand for the procedure from physicians and patients spurred Refractec to step up its plans for a national rollout. The company said that the number of ophthalmologists offering CK will top 250 by year-end, and that it will have trained an additional 100 physicians to perform the procedure by the end of the first quarter of 2003. Refractec also said it has tripled its field force to support the increased demand.