As LASIK (laser-assisted in situ keratomileusis) continues to grow in popularity, every advance in microkeratome design and safety becomes more valuable -- helping to shorten procedure time, increase patient comfort and improve the percentage of excellent outcomes.

In keeping with that trend, the latest microkeratomes boast a number of impressive features, not the least of which is that they can be used with one hand. One of the leaders of this new generation is the Amadeus from Allergan Surgical.

Preventing complications

The Amadeus, which was approved by the FDA last winter, consists of a handheld unit, a computerized control console and two foot pedals. It's been designed to eliminate many factors that have traditionally been the source of errors and accidents:

�         No on-eye assembly. A key factor in producing good outcomes is consistent suction, which helps to create consistent flap thickness. Assembling the microkeratome on the eye after suction has been established risks compromising the vacuum seal, which can lead to an uneven cut. The Amadeus is assembled beforehand, so it's ready to go as soon as a good vacuum is established.

�         Creation of a "protected space." The Amadeus's suction ring is designed to hold the patient's eyelashes and lids away from the cutting area. This creates a "protected space" in which the keratectomy takes place.
Dr. Lee Nordan, of San Diego, Calif., finds this feature to be of major importance. "With some microkeratomes, the blade must pass over the speculum and lid," he says. "Sometimes you need to have a technician pull the lower lid out of the way.
"In contrast, the Amadeus's protected space ensures that you won't hit the speculum, lid or conjunctiva."
Because the Amadeus's suction ring is designed to hold all tissue away from the cutting area, the Amadeus can even be used without a speculum, if necessary.

�         Completely enclosed gearless drive. In addition to the "protected space," this helps to eliminate any chance of the instrument jamming.

�         Multiple built-in safety checks. The Amadeus monitors keratome function throughout the procedure, controls the vacuum level and displays the level on-screen. If a problem occurs, blade excursion stops instantly.

�         Power in reserve. The Amadeus has a backup battery and a vacuum reserve so you can complete your resection, even in the event of a power failure.

�         The same assembly for right or left eye. You don't have to realign any parts to work on the other eye.

�         Hard to damage. The Amadeus is made of titanium, which is lighter and stronger than steel. It also comes with a protective holster you can place the instrument in between cases.

�         Foolproof blade insertion. The blade can only be inserted one way, and it has a plastic guide to keep it from getting "dinged" during insertion.

Delivering precision and consistency

Studies indicate that the Amadeus is highly reliable in terms of producing the flap diameter, flap thickness and hinge width that you set it for. "In my experience, consistency of cut thickness, hinge length and flap diameter have been excellent," says Dr. Nordan.

Dr. Ralph Chu, of Minneapolis, Minn., agrees. "The quality of the Amadeus cut is excellent. The stromal bed is very smooth and the edge of the flap is consistent."

Making your job easier

The Amadeus's design helps to make your job (and your technicians' jobs) easier, while minimizing the likelihood of human error:

�         Assembly is foolproof. The handheld one-piece unit is made up of three components that snap together, and can only be put together in one way. (In fact, the unit won't operate unless it's assembled correctly.) Because assembly is so simple and foolproof, your technicians can handle setup. Your staff can even test the instrument before handing it to you.

�         Turnover time is short. Dr. Nordan describes the turnover time as "spectacular." "Only two parts need to be changed," he says. "This usually takes less than 45 seconds."

�         Extremely short learning curve. Dr. Chu says the Amadeus has the shortest learning curve of any microkeratome he's used. Dr. Nordan concurs. "Some microkeratomes take hundreds of cases to really learn. In my experience, the Amadeus learning curve is one or two cases."

�         Ergonomic design. "The titanium is lightweight and durable, and parameters are easy to change," says Dr. Chu. "The simplicity of the design makes my job easy."
Dr. Nordan adds that Amadeus's vertical design makes it easier to center the ring while looking through the microscope.

�         Audio signals tell you what's happening. In addition to the video display, the Amadeus features sound-activated checkpoints that tell you when its self-check is completed, when a good vacuum has been established, and when the blade's pass is complete.

�         Allergan provides software updates. Allergan responds to feedback from the field by periodically upgrading Amadeus's software to improve the look and performance of the instrument. These upgrades are provided free to surgeons for 1 year after purchasing the instrument.

�         No wasted blades. The disposable blades for the Amadeus are produced in Switzerland. They go through a triple sterilization and cleaning process, and they're checked under a microscope before packing to prevent surgeons from having to discard unused blades.

Giving you greater control

The Amadeus allows you to customize treatments, increasing the likelihood of an excellent outcome:

�         You can set all parameters. Amadeus's console allows you to choose vacuum level, speed of blade oscillation, blade traverse rate and hinge size using the console touchscreen. (The console clearly displays the parameters once you've chosen them.)

�         You have two procedure control options. You can operate the Amadeus using the LCD touchscreen or two color-coded foot pedals (green for go and red for stop). A single tap on the green foot pedal runs the unit through its complete cycle.

�         The flap is visible during the entire procedure. This allows you to abort the procedure if you're not happy with the way the flap is turning out.

The bottom line

Overall, early response to the Amadeus has been positive. As Dr. Chu puts it: "In my practice, we're looking for two things: quality of cut and ease of use. Amadeus gives us both. This is my microkeratome of choice."

The current price for the complete Amadeus system is $59,000. For more information, contact Ron Bache, U.S. marketing director for refractive surgery at Allergan Surgical, at (714) 246-2495.

Are you aware of new products or technology that have made (or are likely to make) a significant difference in practice? Contact Christopher Kent at kentcx@boucher1.com to find out about possible coverage in a future issue.