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Up Front | Oct 2001

Complete Sterile Field LASIK

A new sterile microkeratome may hold the key to making LASIK a truly sterile procedure.

Sterilizing techniques are an inextricable part of the accepted standard of care for ophthalmic surgery. However, in recent months, the safety of the LASIK procedure has received negative press coverage concerning complications, which has undermined the public's confidence in the quality of the work ophthalmologists perform. Now that new technology is enabling ophthalmologists to perform completely sterile LASIK procedures, we need to take the necessary steps to continually deliver a zero infection rate.

LASIK SURGERY: TRULY STERILE?
Infection is the LASIK complication that most frequently leads to severe vision loss and corneal transplant. Unfortunately, there are many surgeons who omit using sterile techniques while performing LASIK surgery, and microkeratomes are the primary culprit. Most microkeratomes cannot be used in a sterile manner, primarily because the motor drives cannot be autoclaved and/or isolated from the surgical field. Because surgeons use these nonsterile instruments, the entire surgical field is compromised and is considered nonsterile. On occasion, the surgical field has even devolved further into a glove-free, street clothes, and unwashed environment that depends on topical antibiotics to provide the necessary infection control. Antibiotics, especially fluoroquinolones, are routinely used to prevent bacterial infections from developing. The fact remains that LASIK surgery is often conducted in a nonsterile environment, and the patient could potentially fall victim to a resistant strain of microbe.

The development of the single-use, preassembled, sterile microkeratome allows LASIK to be performed in a routine sterile manner. The newly redesigned Steritome™ System by Refractive Technologies, Inc. (Cleveland, OH) has opened the door to examining the way in which we perform LASIK. By using a sterile microkeratome in addition to sterile preparation, drapes, and gloves, surgical sterility can be achieved without excessive effort or cost.

AN IMPROVED MICROKERATOME
The Steritome™ System is a highly dependable second-generation instrument, evolving from the original FlapMaker™ microkeratome. The microkeratome's motors and electronics are isolated from the surgical field in the console. Its blades are computer-inspected; my colleagues and I have not rejected a microkeratome for blade defects in 2,500 consecutive uses. In addition, particle debris from the polycarbonate head is absent. The powered head advances at a constant 6.8 mm per second. The blade is set at a 26&Mac251; angle, and oscillates at 12,500 rpm. Whereas the older FlapMaker™ tended to have a slight downward torque, the new unit translates power tangentially to the cornea, eliminating epithelial defects and thinning/buttonhole defects. With only four moving parts, the microkeratome head looks deceptively simple. It does not exert any downward pressure on the eye, and does not require downward pressure to maintain suction while the blade passes.

The clear suction plate offers a full view of the cornea and eye during the entire flap creation process. Limbal blanching allows the user to visualize suction, which adds a valuable clinical sign for safely creating flaps.

By adopting a sterile technique, surgeons may enjoy secondary benefits other than those related to preventing microbe transmission. The Steritome™ has a zero incidence of DLK, possibly due to the lack of contaminant introduced into the surgical site. It has no sterilizer-related biofilms, tissue fragments, cleaning solvents, or lubricant residues.

NEVER SETTLE FOR LESS
Our practice philosophy is to offer the highest level of service to the public. We treat each eye as a separate case, even if we perform simultaneous, sequential surgery on both eyes in the same session. We also have a one-blade-per-eye standard. Using two microkeratome heads and two blades per patient assures me that there is no blade degradation after the first use, and that each flap will be perfect. In addition, I use separate sets of instruments for each eye. We also change drapes and gloves between eyes (Figure 2). This extra effort costs all of 5 minutes and $100. Our patients understand that this modest extra cost helps insure their safety. Sterility can translate in the public's mind into higher quality of care, which can help distinguish a practice and help dispel perceptions of careless doctors and substandard surgery.

Ronald Singal, MD, is in private group practice at the Acuvision Laser Centers in Jacksonville, Florida, where he serves as Director. Dr. Singal has been practicing in Jacksonville since 1977. He has no financial interest in, nor is he a consultant for, any product or company mentioned herein. Dr. Singal may be reached at (904) 751-3600; KCRider@aol.com
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