As a consultant to ambulatory surgery centers, I've got a strong interest in new products that can be of use to my clients. Last March, I walked the exhibit hall at the 2006 meeting of the American Society of Cataract and Refractive Surgery in San Francisco. The Moscone Convention Center played host to almost 300 exhibitors. From replaceable corneal inserts and a torsional phaco handpiece to a corneal biochemical property analyzer, here are a few of the products on display that caught my eye.
Intraocular implants
The buzz in this year's exhibit hall fell short of the excitement generated last year over the unveiling of two new multifocal IOLs: the ReZoom by Advanced Medical Optics and Alcon's AcrySof ReStor. Both companies continue to tout the benefits of their products, but only Eyeonics made recent modifications to its IOL, creating the Crystalens SE. The SE now features a 360-degree square edge on its posterior side, reducing the risk for epithelial cell migration and posterior capsular opacification, says Eyeonics.
AMO's foldable aspheric Tecnis IOLs are now available in acrylic, in addition to silicone. The Centers for Medicare and Medicaid Services recently approved Tecnis IOLs for New Technology Intraocular Lens reimbursement status. A company representative told me that the Tecnis IOLs provide an additional half-second of driving response time when compared to the response times of drivers with spherical lens implants. (On May 21, Alcon announced that its AcrySof IQ IOL also received NTIOL classification of Reduced Spherical Aberration.)
Introduced eight months before the show, Bausch & Lomb's SofPort AO is another IOL with aspheric design that aims to improve vision in low light. Bausch & Lomb says its IOL's unique shape avoids the negative spherical aberration of aspheric designs, with a modified prolate anterior surface.
Alcon's AcrySof Toric IOL corrects astigmatism and provides cataract patients with freedom from glasses for distance vision. In clinical trials, the AcrySof Toric IOL rotated an average of less than four degrees six months after implantation. That stability is attributed to AcrySof's biomaterial and biomechanics. The AcrySof Toric IOL Calculator enhances results, I was told, by pinpointing the optimal axis location for IOL implantation.
Staar Surgical's Visian ICL with collamer technology is a removable phakic implant that is particularly suitable for patients with dry eyes, thin corneas and others who aren't good candidates for corneal ablation, as well as those with inflammatory conditions of the anterior chamber. Approved in the United States early this year for treating myopia, the Visian ICLs cost $800 per lens. Almost 100 percent of patients report satisfaction three years after implantation of the Visian ICL, according to an FDA clinical trial.
Don't expect the IOL field to become less crowded in the near future. In the next few years, the FDA will likely approve hydrophilic acrylic IOLs from Eyekon, Tekia and Human Optics, among others.
Also in the OR
During my travels around the exhibit hall, I discovered several new IOL injectors. I also sneaked a peek at a few other phaco products that will soon impact cataract surgery, particularly Alcon's new torsional handpiece. Here's a brief description of each.
Before I even hit the trade show floor, attendees were talking about Alcon's new Ozil torsional phaco handpiece. Some consider it a revolutionary method for delivering ultrasound to the eye through a 2.2mm incision. A company representative described the torsional phaco's oscillatory movement as shearing the lens, which prevents the longitudinal jackhammering and turbulence created with linear ultrasound. The Ozil also decreases repulsion of nuclear material and reduces heat at the incision, helping with healing, I was told. Another benefit is that the handpiece can deliver either traditional ultrasound or torsional oscillations, or both, allowing for customized treatment.
The Easy-Load injector is part of the Bausch & Lomb SofPort system, which includes the SofPort AO Optics Aspheric Lens. A company representative told me that the system is unique because practitioners snap on a holder and close the injector's drawer, loading the lens into an inserter without having to touch the lens. The goal of this feature is to improve surgical efficiency and minimize the risk for lens damage and contamination.
Duckworth & Kent also introduced a new injector, an alternative to the Alcon Monarch II titanium handpiece. The DK Injector features a plunger instead of a screw mechanism, allowing fast, single-handed delivery of the Alcon AcrySof acrylic foldable IOL. The front-loading cartridges, which are secured with one quick rotation of the sleeve, aren't supplied with the product.
The new Staar Indigo Injector System from Staar Surgical lets surgeons implant single-piece IOLs through a sub-3mm incision. The semi-reusable, one-handed injector and disposable cartridge and tip are supplied for each case by Staar.
AMO's Sovereign phaco system has a new software upgrade, called WhiteStar ICE (increased control and efficiency). The company says it increases cutting efficiency with cavitation power, reducing trauma to the eye. Another key feature the company highlighted is stability in the anterior chamber due to a significant reduction in post-occlusion surge.
Claiming the title of the first new viscoelastic of the century, DisCoVisc Ophthalmic Viscosurgical Device combines the benefits of a dispersive OVD, along with the space maintenance and easy removal of a cohesive product, according to Alcon. The chondroitin sulfate/sodium hyaluronate product is packaged as a single 1ml latex-free syringe.
Knives and instruments
As always, there was a plethora of new surgical instruments on display at the show. Most were enhancements or extensions of previous product lines. A few introduced new concepts. Here is a sampling of what I saw.
Asico had a prolific year, introducing 10 new products at the ASCRS show. One of those products, the Inamura Eagle Prechopper, handles the division of dense nuclei without counterforce because the instrument's narrow tip allows for easier insertion. It also makes nucleus rotation easier in the capsular bag.
Two new eye markers work for Alcon's AcrySof Toric IOL. Featuring a radial pattern at the 3 o'clock, 6 o'clock, and 9 o'clock positions, the Toric Reference Marker allows an approach to the patient from the temporal position. This means you can perform pre-op marking on either the right or left eye with a single instrument. The fixed axis marks on the Toric Axis Marker are easily aligned with these pre-op reference marks; its rotatable marker barrel then lets surgeons determine the precise location of the steepest meridian, while its built-in keratometer quickly confirms this measurement.
With the need to get patients astigmatism-free before insertion of multifocal lenses, limbal relaxing incisions have become an important part of cataract surgery. Asico's Zaldivar LRI/Axis Marker and Koch LRI/Axis Marker have an axis extension to easily align with the steepest meridian, and a degree gauge for precise alignment. The Zaldivar marks the cornea at 10.5mm, while the Koch marks at 10mm. Both can correct astigmatism of one and two diopters.
At last year's show, BD Ophthalmics introduced the Cataract Safety Knife System, with its shielded, retractable blades - a step forward in the quest to reduce sharps injuries. Renamed the BD Beaver Safety Cataract Knives, the collection has expanded to offer two new sizes: the 3.2mm, angled, single bevel and the 2.2mm slit for coaxial micro-incision phaco.
For the vitreoretinal surgeon, Iridex adds the IRIS Medical Stepped EndoProbe handpieces to its existing line of disposable endophotocoagulation probes. With a non-mechanical, ergonomic design, it has a gently tapered needle, which permits its angled tip to be inserted through standard 25-gauge, 23-gauge, and 20-gauge cannulas. The 25-gauge to 30-gauge model is the only fixed angle probe available for 25-gauge surgery.
Oasis Medical's Terry-Schanzlin Astigmatome is a disposable microsurgical cutting instrument used for corneal relaxing procedures. Employed in the office or operating room, it can correct astigmatism during or after cataract or lens implant surgery, corneal transplants, corneal grafts or other applications. Boasting superior results over freehand limbal cuts, the Astigmatome offers 10 cutting templates with predetermined arc lengths (zero degrees to 360 degrees, 30 degrees, 45 degrees, 60 degrees and 90 degrees) to create uniform lengths for both 8mm and 10mm optical zones, says the company.
Providing multiple approaches for nucleus separation, the new Kim Chopper by Pelion Surgical combines - on the same handle - a traditional, horizontal phaco-chopping tip with a unique, triangular-shaped tip for performing a modified horizontal quick chop. According to a company representative, the new AMO Lens Loading Forceps has a curved front to pick up the lens, therefore making the lens easier to manipulate.
Rhein Medical's new line of single-use sterile instruments, called Eco's, carry quality and durability to rival their reusable counterparts, say company representatives. The stainless steel ophthalmic instruments are packaged sterile or non-sterile to accommodate the regulatory requirements of hospitals. They come six to a box and include steel rotators, manipulators, choppers, forceps, needle holders, scissors and speculums - all the bread and butter ophthalmic instruments, says the company. Although they're labeled single-use, they can withstand multiple autoclave cycles, says the company. Benefits range from lowering cross contamination to lowering costs for repair of expensive instruments. A Rhein Medical rep says surgeons can simply throw damaged instruments away and open a new one from the supplied box of six.
Katena Products highlighted several new instruments at their booth. The Burnstine Lacrimal Cannula features an end opening port for direct irrigation and tapered tip for ease of entry into an undilated punctum, Katena says. For inserting donor tissue during lamellar surgery, the company now offers its Rosenwasser Donor Lamella Inserting Forceps. The instrument is designed so the tips cannot completely close, ensuring the tissue is held and not crushed. Katena says its Giannetti HydroChopper is suited for both nucleus division and manipulating fragments within the capsular bag, while the 23-gauge Fukasaka HydroChop Cannula features a vertically flattened tip for easy insertion into the central core of the nucleus.
Diamatrix also entered the mix with several new instruments. The Mann UltraTrap Diamond Knife is designed for use with Alcon's new MicroSmooth Ultra Infusion Sleeve and the Monarch II cartridge, and is suitable for any MICS application where a sub-2.5mm incision is required, the company says. This instrument lists for $2,300 and is available in straight, angled or stepped titanium handles. In addition to an entire line of instruments released for use with the Staar Visian ICL, Diamatrix also displayed its Wright LDS Diamond Sideport Knife, a blade that sizes incisions to the correct width (1.3mm) for bimanual phaco without engaging the anterior capsule. The blade lists for $850.
A new addition to Surgical Specialties' Sharpoint line, the IQ Geometry Slit Knife, merges two micro-thin radii to create an edge that contacts tissue at only two points. Forty-percent thinner than typical slit blades, the IQ Geometry Slit Knife reduces penetration force and causes less friction, creating a better self'sealing wound, according to a company representative.
Capital equipment for eye rooms
There wasn't a shortage of big-ticket items on display in the exhibit hall. From laser systems to scopes to imaging systems, here's a look at some of the latest choices available.
Leica displayed its new surgical scope, the M820 F19, an apochromatic optical system with the halogen bulb in the optical head. This direct illumination system gives the surgeon a sharper and more homogenous image than a fiber optic system, says Leica. A unique feature: Surgeons can program predefined levels of light, focus and zoom used during a typical surgical procedure. Later, in the midst of surgery, those settings can be activated with a button on the scope's foot switch.
With exclusivity in the U.S., the Lumenis Selecta 1064 provides a unique modular and upgradable laser platform for treating the anterior segment of the eye, secondary cataracts and peripheral iridotomies. Depending upon the makeup of your practice, you can add the Selecta Duo ($29,000) - which combines the Nd:YAG with 532nm photocoagulator combination laser - to the basic platform. This allows your surgeon to do procedures involving both the anterior segment and posterior pole. You can also add the Selecta Duet ($89,900), which lets you treat open-angle glaucoma with a selective laser trabeculoplasty. The third option is the Selecta Trio ($109,900), a single platform featuring an Nd:YAG, photocoagulator and SLT combination laser. A company representative made a point of highlighting the platform's wheelchair-accessible table and fully integrated slit lamp.
At the time of the 2006 annual meeting, Optronics was three weeks away from releasing its new Firewire-based, digital, 3CCD Microcast - the first medical grade digital camera developed specifically for surgical microscopes. Highlighting its user-friendly qualities, a sales representative told me that the Microcast system was easy to install on any surgical microscope and could be used with little training because of its intuitive on-screen menu. Providing 36-bit RGB real-time image processing, the system allows you to broadcast your surgery throughout the operating room, the company says. And remote control programming is possible using either a tactile keypad or buttons on a lightweight camera head. The system's list price is $9,495.