From the Show Floor: What I Saw at ASCRS

Share:

Reviewing the new products for cataract surgery.


As the medical director of a busy ophthalmology-based ASC, I'm always interested to see the latest developments in the field. The exhibit hall at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators' annual meeting in Washington, D.C., in April didn't disappoint. About 300 exhibitors put their products out for inspection, and more than a few may make a big impact on our procedures.

Here's my rundown of some of the products for better patient care, instruments for more precise procedures and just plain neat technology I saw there.

Accommodative IOLs
Presbyopic correction with cataract surgery or refractive lens exchange is becoming more feasible with advances in IOL design. The biggest news at the ASCRS exhibit hall was the rollout of two new presbyopia-correcting IOLs, Advanced Medical Optics' ReZoom and Alcon's AcrySof ReStor, both of which had been FDA-approved in the weeks leading up to the conference. (The FDA approved CrystaLens from Eyeonics, the first accommodative IOL on the market, in November 2003.) Both ReZoom and ReStor offer near and distance vision - an improvement over standard implants, which only give one or the other - but each delivers it through different methods.

AMO's ReZoom is a second-generation refractive multifocal acrylic IOL that the company says provides cataract patients with greater independence from glasses than monofocal IOLs. The three-piece lens achieves its multiple focus ability by distributing light over five optic zones, arranged in concentric rings like a target, that alternate between distant- and near-dominant vision.

Alcon's AcrySof ReStor, on the other hand, is an apodized diffractive IOL that seeks to free patients from their glasses. Apodization, a company rep explained, is the gradual reduction or blending of diffractive step heights. The ReStor lenses' steps are arranged into 12 concentric rings, each narrower than a human hair or red blood cell. Because it distributes light to near and distant focal points at the same time, you get a full range of visual function within each ring.

I just want a product that patients will be pleased with routinely, and the two companies were quick to address that concern as well. AMO's reps said that 92 percent of ReZoom recipients "never or only occasionally wear glasses," while Alcon had clinical studies showing that 80 percent of ReStor patients "never needed glasses" after bilateral cataract surgery.

Some observers have raised questions about the lenses' performance at intermediate distances, such as reading a computer screen or a car's dashboard, or about the incidence of nighttime glare and haloes. An Alcon rep pointed out, however, that with this type of lens and procedure, you're going to spend a lot of time counseling and educating the patient on what's to be expected. That's an especially important point, since Medicare makes these new multifocal IOLs - each of which costs $895 - available to patients only if they're willing to bear the extra cost of the new technology. Medicare reimburses ASCs $200 for the new-technology IOLs; patients must pay the extra costs out-of-pocket.

Staar Surgical also presented an IOL, the Collamer three-piece posterior chamber lens. It's an injectable, biocompatible lens made out of a collagen-copolymer material that the company describes as similar to the eye itself. Staar claims this IOL is self-healing in the event that a laser or needle pierces it, and studies have shown it induces fewer higher-order aberrations than other lens materials. The Collamer lens costs $125.

Pharmaceutical news
This year's conference also saw the return of hyaluronidase to the market after a four-year hiatus. A purified protein enzyme, hyaluronidase helps to speed and spread the effects of regional anesthetics injected around the eye.

As you may recall, Wyeth Pharmaceuticals manufactured Wydase, a patented formulation, until 2001. Since its withdrawal, the only available option was to ask your pharmacist to mix you an expensive single-use dose of the drug, and that was only if your state's laws or hospital's rules allowed the use of compounded products. In Ohio, where I practice, they didn't.

At the exhibit hall, two firms presented newly FDA-approved, ready-to-use formulations of hyaluronidase: Amphastar Pharmaceuticals' Amphadase and Ista Pharmaceuticals' Vitrase.

Amphadase markets itself as the exact same formulation as Wydase, a preparation of purified bovine testicular hyaluronidase. The company has priced the product at $20 per 1ml vial and packaged in quantities of 10 and 25 vials.

Ista describes Vitrase as an improvement over Wydase. This hyaluronidase is ovine-, not bovine-based, coming from New Zealand sheep instead of cattle. In addition, it's thimerosal-free, sidestepping potential allergic hypersensitivity to the mercury-based preservative. A 1.2ml vial is $26 and sold in quantities of six.

In other drug news, Bausch & Lomb's Retisert could be big, even though the product itself is small. The intravitreal implant, which is about the size of a grain of uncooked rice, is designed to treat chronic, non-infectious uveitis, a sight-threatening inflammatory disease. Sutured in the posterior segment of the eye, the tiny drug reservoir delivers an anti-inflammatory corticosteroid for about 30 months, the company says. The list price for the implant is $18,250.

Knives and instruments
American healthcare workers suffer nearly 600,000 sharps injuries each year, according to the Centers for Disease Control and Prevention. The existence of bloodborne diseases makes those injuries a deadly risk. BD Medical's Cataract Safety Knife System aims to make some of them avoidable.

The collection offers single-use phaco slit knives equipped with Xstar blades in a range of sizes and an anterior chamber MVR knife with an EdgeAhead angled blade. Each knife is engineered with a locking, retractable safety shield designed to protect surgeons and OR staff throughout the procedure as well as to protect the blade from damage - and keep it impressively sharp - until it's needed. The knives are the same size and weight as conventional scalpels, so they feel good in your hand, and the shield is simple enough to retract and replace with one finger. The knives list from $10 to $20 each. While a company rep admitted that may be slightly more expensive than other single-use scalpels, he added that compared to the physical, financial and emotional cost of a sharps injury, it's not too high a price.

For more than 25 years, MicroSurgical Technologies was a silent supplier, manufacturing phaco tips and irrigating/aspirating handpieces for major phaco machine manufacturers. In recent years, they've been marketing their own brand of products, and at ASCRS they presented the Duet Forceps System. The system features an ergonomically designed universal handle and interchangeable heads for work in small incisions, including scissors, capsulorhexis forceps, micrograspers and microtyers. The interchangeable heads allow for easier cleaning inside the cannula as well as convenient equipment upgrades. The handpiece retails at $450 and the forceps tips at $450 to $900.

Rhein Medical showed its Seibel LRI Diamond Knife, a reusable, autoclavable titanium scalpel with a 1mm wide snub-nosed diamond blade and pre-set, spring-loaded blade extension settings of 0.5mm, 0.55mm, 0.6mm, full extension and full retraction. Rhein also offered the Ruminson Astigmatic Gauge and Marker, a 360-degree gauge for marking corneal incisions at any axis, and four variations of Dell LRI Markers for measuring limbal relaxing incisions and the exact placement of toric lenses. Rhein Medical wouldn't disclose prices for the tools.

Accutome also offers an adjustable knife, the Rubenstein LRI Diamond Knife. The Rubenstein, which has three pre-set extensions of 0.5mm, 0.55mm and 0.6mm, features a polished, low-profile, winged footplate that allows a full view of the blade during incisions and that "glides across the corneal epithelium," the company says. List price is $475.

Feather Safety Razor Co. introduced its Implant Knife with Guide, an angled stainless steel blade with a 1mm wide raised guide running down the center of the blade. The guide lets a surgeon widen a corneal incision from phaco tip to lens injector size without deviation. Distributed by Oasis Medical, the knife lists at $165 for five.

Intraocular hardware
At ASCRS' 2004 show, FCI Ophthalmics introduced the Morcher Capsular Tension Ring. This year FCI - the American distributor for German manufacturer Morcher - showed products that aim to build on the rings' success. Cionni Capsular Tension Rings support and center an implant in the capsular bag in the event of loose or missing zonules. The 11mm rings are available with a fixation hook on the left, right or both sides. Ahmed Capsular Tension Ring Segments offer similar support for a section of the zonules. Both the Cionni and the Ahmed are as yet awaiting FDA approval, but once they clear that hurdle, I anticipate that you're going to see a lot of them in use.

FCI's Morcher Pupil Dilator is already selling quite well, a company rep says. A single-use, temporary implant ring that expands the pupil during phaco procedures, this product is one that I've been watching surgeons use and I want to try on my own patients. List price is $149.

Also at FCI's booth was the Self-Retaining Bicanalicular Stent, a silicone tube for the treatment of punctual stenosis or canalicular obstruction. The company says it can be inserted into the lacrimal ducts while the patient sits in an examination chair under topical anesthesia. The stent, which lists for $89, is 0.64mm wide and 25mm, 30mm or 35mm long with flexible flaps at each end that insert into and then anchor at the lacrimal sac.

Imaging equipment
It's entirely possible that the main reason you won't buy Leica's M844 Ophthalmic Surgical Microscope just yet is because the Leica Wild M690 scope you bought, new or refurbished, is still working flawlessly; I've found Leica scopes to be incredibly reliable. The M844, the company's next-generation, high-resolution cataract and retinal scope, features direct halogen illumination, not fiber optics, for a sharper field and crisper image. A touchscreen control unit does double duty as a video monitor, removing the need for a separate video cart, and programmable settings allow quick changes between different steps of the procedure and different users. The M844 lists for about $90,000.

In cases where patients have particularly dense cataracts that obscure intraocular examination, getting a view inside might help a surgeon more accurately assess other aspects of optical health before determining courses of action. Zeiss's StratusOCT employs optical coherence tomography - a process similar to ultrasound, but using a laser instead - to capture real-time, cross-sectional images of a patient's retina, the company says. The resulting vivid false-color images offer the opportunity to measure and evaluate retinal structure, health and damage without cutting into the eye. Cataract surgeons could use this device in conjunction with other technologies to manage pre- and post-operative retinal analysis more effectively. The list price for the StratusOCT is $50,000.

Related Articles