Customized flap possible with mechanical microkeratome

January 1, 2005

Paris-The Amadeus II microkeratome (Advanced Medical Optics) builds on the advantages of its predecessor with new features that enhance safety, efficiency, and ease of use, said Eric D. Donnenfeld, MD, at the XXII Congress of the European Society of Cataract and Refractive Surgeons.Dr. Donnenfeld presented a study in which he evaluated the Amadeus II in a series of 100 eyes of 50 patients.

"While we have been very happy using the Amadeus microkeratome for 4 years, the Amadeus II is a technologically advanced instrument that is even more user-friendly and more versatile in allowing for customization of flap parameters on a case-by-case basis," said Dr. Donnenfeld, national medical director, TLC Laser Eye Centers and founding partner of Ophthalmic Consultants of Long Island, New York.

"My experience shows that it consistently maintains suction and produces flaps with excellent symmetry and contour quality that fit well into what is an extremely smooth, underlying stromal bed," he said.

Flap thickness was calculated by subtraction pachymetry and the results showed good predictability with both heads. Mean ±SD flap thickness for the 140-µm head was 133.89 ±12.92 µm (range, 101 to 178 µm) and was 143.16 ±14.36 µm (range, 119 to 185 µm) for the eyes on which the 160-µm head was used. With few exceptions, the achieved flap thickness was ±20 µm of the labeled value in the 140-µm group. In the 160-µm group, the vast majority of flaps measured <160 µm.

The only complications encountered were two small epithelial abrasions, and there were no significant complications, such as buttonholes, irregular flaps, free flaps, or striae.

Revolutionary advances Like the Amadeus, the Amadeus II offers titanium construction and variable oscillation and translation speeds. In addition, it still provides surgeons the ability to create nasal-hinged flaps and to customize hinge widths.

The new model, however, is even lighter and so more ergonomic and easy to control. In addition, it comes with a greater selection of flap sizers and spacers along with new features to enhance safety. Automatic assembly guides eliminate the risk of improper assembly, and there is new software providing surgeons with voice-confirmation feedback during use. That system reports to the surgeon when the safety pretest is done and calls out each step of the procedure as it is performed.

The Amadeus II platform comes in three widths-normal, narrow, and Asian-that allow it to rest safely and comfortably in a wide range of eyes regardless of orbit configuration. Like the Amadeus, it can create flaps measuring 8.5, 9, and 9.5 mm in diameter, but it also brings the option for a larger 10-mm flap.

All of the mechanical components of the Amadeus II are internalized, and the instrument weighs in at about 70% lighter than the Amadeus by virtue of its smaller handpiece and lighter, more flexible cords.

"The Amadeus II offers greater ease of use and also traverses the eye more easily. With its unique features, surgeons can use this microkeratome with increased confidence about safety and flap quality," Dr. Donnenfeld said.

The Amadeus II has also been designed with an upgradable platform that allows it to be used with an epi-LASIK head for separating the corneal epithelium from the stroma.