More than 250 vendors displayed the latest technologies and products for ophthalmic surgery in the exhibit hall of the 2004 meeting of the American Society of Cataract and Refractive Surgeons in San Diego in May. I am always assessing new products for the outpatient centers I consult with - and I got a chance to look at some fascinating new technology. In the space that follows, I'll give you a tour of the ASCRS floor, highlighting what's new since last year.
Expanding IOL options
There's not much that's brand new when it comes to IOLs, but manufacturers have made several notable enhancements. Here are the updates, alphabetically by company.
- Alcon. Acrysof Natural's yellow coating blocks what the company says is dangerous blue light, which can damage the retina and could cause age-related macular degeneration. The IOL is an extension of the company's acrylic line and is priced as a premium IOL, but Alcon wouldn't give a price.
- AMO. AMO has launched its Clariflex and Array and will soon launch its Sensar and Clariflex lines of IOLs for extended diopter ranges. According to the company, the acrylic Sensar now has a range of '10D to 30D. Previously, the lowest acrylic on the market was '6D, according to an AMO representative. The silicone Clariflex and the silicone Array Multifocal now come in '10D to 30D; AMO says the lowest silicone diopter previously available was '4D. AMO says it is the only company to manufacture both acrylic and silicone extended-diopter lenses, which let a surgeon avoid putting same-material IOLs on top of each other. In addition, the Sensar, Clariflex and Array come in half-diopter increments, which can help correct smaller refractive errors and residual refractive errors. You may get reimbursed for implanting the IOLs to correct residual error after the first surgery, but you should have an ABN on file with the payer.
With the acquisition of Pfizer, AMO also gets the Tecnis Z900, which the FDA approved in March for several new label claims. According to Mary Ellen Esgro, the global senior product manager for Tecnis, the company took wavefront for corneal aberration, applied it to the IOL and came up with a modified prolate anterior surface. The result is the new claims, including better functional vision, low-light vision and visual acuity. "Older patients might not be driving at night," says Ms. Esgro, "but what about getting up at night to go to the bathroom? Or reading a menu in a dimly lit restaurant? Or driving on a rainy, foggy day?" Ms. Esgro wouldn't give a price but said the Z900 is priced as a premium lens.
- Eyeonics. The company's Crystalens is the only accommodative IOL on the market. The Crystalens was approved by the FDA Nov. 14 for adults with cataracts only. According to an Eyeonics representative, surgeons must be credentialed to use the lens; to earn that status, they must be within 10 points of post-op refractive targeted outcomes after lens-specific training. That way, your patients will have similar or better outcomes than documented in the lens's FDA trials. The company estimates the charge to patients for implantation of the Crystalens to be between $4,500 and $5,000 per eye.
- Staar. Staar has released a low-diopter, three-piece silicone piggyback lens ranging from 5D to '5D in one-diopter increments. These lenses are for use when there is a malfunction of the IOL implantation; instead of doing an IOL explantation, you can implant the piggyback lens over the original. According to a company representative, Medicare will reimburse the procedure as a second IOL; the low-diopter three-piece intraocular lens is priced around $200, about $30 over the extra reimbursement.
- Thin Optix. The company says it just received approval from the FDA to begin a study of its IOL in the works, the Thin Lens, in the United States and estimates the lens is about two years away from the U.S. market, if all goes as planned. The Thin Lens, available in Europe and South America since 1992, is rolled instead of folded and can be inserted through a 1mm incision. The key, says Jim Simms, the company's vice president of marketing and sales, is in the design; rings are cut into the IOL, which not only removes a lot of mass, keeping it thin, but also helps adjust for spherical aberration.
Capsular tension rings
The first capsular tension ring was approved for use in the United States last October, and the technology presents a new way to handle cases of weak zonules during cataract surgery. There are now two on the market, AMO's Stabileyes and FCI Ophthalmics' Morcher capsular tension ring, and both were on display at ASCRS. Both are indicated for use with complex cataract cases, such as missing or damaged zonules or lens subluxation and both help expand the capsular bag to stabilize the eye intraoperatively. Without the capsular tension ring, which is permanently implanted, the damaged or broken zonules could lead to implant dislocation resulting in refractive changes, decreased vision, or even implant dislocation requiring additional surgical intervention. Weak or broken zonules occur during surgery in 1 percent to 3 percent of cataract patients. Just about every cataract surgeon I talked to was buying capsular tension rings and taking courses on how to use them; in my opinion the CTRs were the among the biggest news and the most exciting newly FDA-approved products.
Using a capsular tension ring during cataract surgery qualifies the procedure as complex cataract surgery, CPT 66982 - so your facility may get paid extra for using the device, coded as HCPCS L8699 (prosthetic implant, not otherwise specified). You might also be able to get reimbursement for the ring separately as a prosthetic device if your facility is an ASC. You'll decrease denials by including supporting documentation - such as the ring's necessity to the surgery - with the claim.
It wasn't hard to spot a trend developing in cataract surgery toward bimanual phaco, which requires smaller incisions, and there was no shortage of new micro-incision knives. Just about everyone who makes ophthalmic knives - diamond, metal, reusable, disposable - was touting a micro line. Here's an alphabetical listing of the new knives and a couple highlights for each.
- Asico. The Clear Path Diamond Knife has an intercolonial valve and a 1.5mm shelf, which eliminates the need for a change of hand position as you make a cut. The $2,200 price tag includes a sterilization tray.
- BD Ophthalmics. BD is offering a safety-handle knife that is available with a wide variety of blade sizes. The one-handed activation of the safety device is something I especially liked. A BD representative said the safety handle means a slightly higher price over non-safety BD knives, but wouldn't give specifics.
- Cytosol. The Exactetch line comprises several sizes and blade shapes of chemically etched single-use stainless-steel knives that were among the lightest ones I encountered. The company says the chemical process makes the blade sharper and more precise.
- Diamatrix. The company now offers smaller blades in metal, diamond and sapphire that can be mounted on the Saf T Guide handle. The company says the feature, which you activate by twisting with both hands, is the only active sharps safety knife on the market.
- Huco. The 0.9mm Fud diamond knife has a trifacet blade with vertical cutting edges, which increases its maneuverability in all ophthalmic applications, the company says.
- Oasis. The Premier Edge line of single-use knives come in 1.0mm, 1.5mm and 3.0mm sizes. A non-grinding process is used to form the point on the stainless-steel blades. One knife of note in the line was the hex-agonal knife, which the company says is like three in one.
- Pelion. The Universal diamond cataract knife with Triamend tip was the highlight of this company's line. The tip is microfaceted and truncated, but shaved down so that it is both sharp and less vulnerable to chipping. I found that the titanium handle made the knife light. In addition, the knife was easy to manipulate because of its self-locking mechanism for each depth setting.
- Rhein. The 3-D Bi-Manual Phaco Blade is a 1.2mm to 1.4mm single-use knife.
- Rumex. The Side Port Micro Incision diamond knife is specially designed for cold phaco technique and for incisions between 1.5mm to 1.8mm, the company says.
- Stephens Instruments. The Extra-Edge Angled Knives are stainless steel and chemically sharpened.
- Surgical Specialties. The Sub-2mm Series boasts 10 knives (soon to be 12), which the company says is the largest offering on the market.
- Surgistar. The company offers a complete line of stainless-steel microsurgical knives.
There were plenty of big-ticket items at the show to grab your attention, too. Some were updates of old equipment and some were brand new; here's the rundown.
- Accutome. The Accusonic A-Scan's software was recently upgraded to make it easier to measure IOLs more precisely, according to the company. It has a 7.5-inch LCD screen, yet is compact and portable, and desktop-, slit lamp- or wall- mountable. The A-Scan's real-time waveform display and eight-times zoom help pinpoint tissue boundaries; it continuously displays axial length, ACD, lens thickness and vitreous dimensions, Accutome says. In addition, the device instantly calculates IOL powers for dozens of lenses and can compare measurement results for all modern formulas (such as Hoffer X, Holladay and SRK/T) on a single screen.
- American Optisurgical. AOI purchased the Mentor phacoemulsification line from Paradigm Medical and has redesigned the modules of that company's SIStem phaco machine. According to the company, the SIStem provides more features more cheaply than similar phaco machines, including up to 12 user programs, multi-modular phaco settings, a closed aspiration network, infrared remote control and automated surge suppression. You also have an option of disposable or reusable non-invasive tubing, according to AOI.
- Carl Zeiss. The company had three new ophthalmic scopes on display: the Visu 140, Visu 160 and Visu 210. The 140 is specific to the ophthalmic market and is streamlined for cataract surgery; it has all the mechanical and optical quality you want, but it's easier to use and affordable (about $32,000 - roughly the price of a refurbished scope), the company says. Basically, they've taken off the knobs and adjustments you don't need if you're planning to use the microscope only for cataract surgery. The 160 has a depth-of-view management system optimized for light transmission and higher resolution, Zeiss says. It automatically adjusts and has focused slit illumination, which lets the surgeon see the back of the capsule, according to Zeiss. The 210 is the Cadillac of the three. It has magnetic brakes, a fully integrated, stereo assistant's microscope, and the arm can be moved by a non-sterile person. And the 210 has xenon instead of halogen bulbs for whiter light, better contrast and better detail recognition, the company says. Overall, I really liked these scopes' user-friendliness.
- Haag-Streit. The Moller Eibos is a non-contact ophthalmoscope that will allow for simultaneous observation of the fundus and incision area, the company says. The attachment is available on the new Moller Hi-R 900 operating microscope and most other scopes and has a swing-away position that won't interfere with cataract surgery. The Hi-R 900 provides high resolution and red reflex, according to the company; you can opt for the assistant scope attachment, which has the same zero-degree viewing and stereo vision, but separate magnification and focusing mechanisms. The Eibos, which the company says is ideal for quick inspection of the posterior segment and is safe for the eye because of its spring-loaded suspension, and the Hi-R 900 are distributed in the United States by Platinum Medical.
- Laserex. The Ultra Q Laser is upgradeable for glaucoma, or you can leave it as is for doing YAG capsulotomies. According to the company, the machine's laser cavity, which is called the Ultra Q, lasts three times longer than any other YAG laser, getting from 300,000 fires to 400,000 fires instead of 100,000 before the cavity needs to be replaced. It was also 30 percent faster than other YAGs in trials, the company says. Because it costs between $8,000 and $10,000 to replace the laser cavity every three or four years (with the standard 100,000 shots), and because you only have to replace the Ultra Q every 10 or 12 years, the company says you can save at least $25,000 over the life of the Ultra Q. In addition, a wheelchair-accessible design is available; on it, the chin cup is at least four inches lower than that of any other on the market, says Laserex.
- Surgical Design. The Ocusystem ART phacoemulsification machine's software has been updated, the company says; it can now be used to perform cold phaco and can store nearly 3,200 auto settings. An enhanced adjustable rise time (ART) controlled by a microprocessor allows you to better maintain chamber stability, according to Surgical Design.
- UFSK International. The German company's 6000 XLE mobile operation chair is designed for ophthalmic surgery and was released to the U.S. market last winter. The chair lets you keep the patient on one surface in pre-, intra- and post-op. Features include a memory controller with four pre-set buttons, an undercover foot control, an adjustable head rest and electronic brakes. You can upgrade to an aluminum chassis to lighten the table by 20 percent, UFSK says.
There were plenty of products on display that don't fit into any category but this one: Things that will make your life a little easier. Here's a rundown:
- Appasamy Associates. I had heard about the company's Trypan Blue Dye before going to ASCRS, but this was my first chance to actually see it. According to the company, it's a non-sterile product and as such has an FDA exemption. The company says the blue dye produces a clearer stain than green, works well even on dense, white cataracts and is 75 percent cheaper than green dye. The VHA system is studying Trypan for its efficacy.
- Eyekon. The company has a new holder-folder called the Hydro Fold System that automatically folds the IOL; all you have to do is grab the IOL with it. I'm not used to folding IOLs, so it took me a while to get the hang of it, but I think this would help anyone who performs this task regularly.
- Impex. The Phillips-Mackhool headrest for temporal eye surgery is higher on one side, so it wraps around the head, stabilizing it while a surgeon makes an incision on the opposite eye. If you're doing both eyes during the procedure, you just switch the headrest around to the other side. I thought this was neat and, at $295, not overly expensive.
- Mastel Precision. Nursite is a magnification device that will help you better see what you're doing when you're loading IOLs into an injector - or help you just want to do a thorough visual inspection on instruments, the company says. It offers stereo depth of field for critical tasking, is sterilizable and lists for $395.
- Rhein. The Brown Silicone Lens Cutter can be inserted through a 2.6mm incision for the cutting of silicone lenses, a smaller size than previously, according to the company. You can use the cutter's jaws to grasp and remove lens fragments from the anterior chamber. It is reusable and autoclavable, says Rhein.