spotlight on technology & technique
Standardizing LASIK
Among the goals of the LaFaci Surgical System: make steps reproducible to lessen complications.
By John Parkinson, Associate Editor

The LaFaci Surgical System creates a sanitary environment and offers an alternative way to perform many of the steps involved in LASIK procedures. The system provides several functions throughout LASIK to facilitate a smoother operation -- all through the use of a single handpiece.

The system consists of a handpiece; a surgical cart that includes a pivoting instrument tray, a tubing swing arm, and a bottle hanger bracket; a guarded plume evacuation switch; a guarded air/irrigation/aspiration (AIA) foot control; sterile and nonsterile disposable tubing; and smoke/fluid collection accessories, which include a fluid canister and plume smoke filter.

The system helps the surgeon perform all of the following functions during LASIK: surgical field containment, ciliary vessel tamponade, preemptive surgical field fluid removal, temporary flap placement, ocular fixation, stromal bed hydration control, proximal plume evacuation, aspiration, irrigation, flap repositioning, and flap adherence.

LaFaci, short for LASIK facilitator, was developed by Leon LaHaye M.D., president of Opelousas, La.-based Vision Pro, LLC. Dr. LaHaye says the development of the LaFaci was an evolutionary process. The foundation for today's instrument was laid several years ago when he was performing ALK. Years later, when LASIK became the most dominant refractive procedure, Dr. LaHaye turned his attention to decreasing the number of patient complications associated with that procedure and eventually developed the LaFaci.

Dr. LaHaye views LASIK as being divided into two stages. The first stage is the creation of a flap, and the second is from the time the flap is lifted until it is fixated. While he acknowledges technologies have made LASIK better, especially with flap-creation, he says surgeons are still dealing with patient complications that occur mostly in the second stage.

The complications associated with this stage include interface infections within the flap from contamination, noninfectious inflammatory conditions such as DLK, inconsistent or nonstandardized laser pulse etching because of masking by the laser plume, and other issues that could affect the patient's recovery and final outcome.

Along with attempting to decrease complications, another major factor in Dr. LaHaye's developing the LaFaci system was his desire to standardize LASIK in order to get more reproducible outcomes. Normally, LASIK must be performed using different tools and equipment. Having a solitary handpiece in place that carries out many of the separate tasks during the procedure can deliver consistency to the process, according to Dr. LaHaye. "It is very crucial in being able to achieve reproducible and consistently successful results," he says.

LASIK With LaFaci

Surgery with LaFaci begins with the placement of the handpiece on the eye. This should be done directly following the keratotomy but prior to lifting the flap. The handpiece is kept in place by an anatomically supported platform and is manually applied by the surgeon. While it isn't necessary for anyone besides the surgeon to hold the handpiece during the procedure, a technician can hold it.

Once in place, the handpiece facilitates several functions:

► Its conformed fit provides a means of controlling eye movements relative to the handpiece.

► The handpiece can suppress stromal bleeding caused by the keratotomy. The handpiece is designed to provide 360 degrees of nontraumatic pressure on the limbal ciliary vessels therefore allowing for hemostasis.

► Once the flap is lifted, the system's handpiece provides a non-metallic platform to support the flap. The platform is made of an FDA-approved polymer that has passed laboratory reprocessing and sterility validation testing.

► During LASIK, when fluids start to build up, surgeons use sponges to dry the stroma. The LaFaci provides a foot-switch-activated evaporation feature that provides air to the surgical field. The system delivers a uniform, symmetrical, sterile, laminar airflow to the stromal bed at a rate of 0.5 ml/sec to remove excess fluid.

► During the excimer laser phase of the procedure, the LaFaci handpiece removes the laser plume and particles with a laminar vacuum flow through seven ports within the handpiece. This function minimizes vertical plume and particle exposure, alleviating potential health issues and toxic odors.

► As irrigation is used at various times throughout LASIK, the LaFaci system streamlines the process by having the ability to hydrate the surgical field and then simultaneously aspirate excess fluids. The irrigation system is linear-controlled and sterile. This feature is controlled by a foot pedal.

► The LaFaci aspiration ports are designed to remove fluids from the lowest point within the cylinder body of the handpiece. The design of the port will prohibit any obstruction from conjunctival
tissue.

► Upon completion of the laser treatment, the platform that supports the flap during surgery will pivot and rotate, essentially flipping over, so that the flap will reposition onto the stromal bed.

► Lastly, the system will aid with flap adherence through the release of air from the handpiece. This may decrease the amount of time traditionally used by surgeons to observe flap adherence from minutes to seconds according to Dr. LaHaye.

Benefits

While there are a number of features and complexities to the system, Dr. LaHaye says that surgeons who use the system will benefit by standardizing their LASIK procedures, and at the same time decreasing complications that happen in the second stage of LASIK.

Additionally, because this system streamlines many aspects of LASIK, it helps save time. Dr. LaHaye reports that he has increased his operating room efficiency substantially. He says it generally takes him under 2 minutes from placement of the handpiece to completion of the surgery. He has performed LASIK using the LaFaci on approximately 90 eyes thus far.

Challenges

Doctors should be cognizant of a learning curve when first using the LaFaci. Just like getting acclimated to any new instrument, system, or technique, the introduction of the handpiece to the LASIK procedure can take some time. A big part of this learning curve is performing LASIK with fewer tools and equipment. However, surgeons will no longer need sponges, forceps, irrigating cannulas or other instruments associated with flap management and irrigation when working with LaFaci. Dr. LaHaye comments on the differences in using the handpiece as opposed to several different instruments throughout the procedure: "There's more hands-on [using the LaFaci], but you don't need anything else."

He also offers some pearls for using the system:

► During use of the air delivery feature it is important for the surgeon to learn to standardize his or her desired amount of hydration of the stroma before and after laser delivery. This is done by visualization of the target stroma through the operating microscope.

The stroma will appear shiny when excessive beam-masking fluid is present. The surgeon can deliver laminar flow sterile air across the target stroma via the handpiece by use of a micro-foot switch to titrate the desired amount of stromal dehydration.

► Flap repositioning does require an orchestrated manner. The surgeon, using his free hand, engages the platform at the designated point with the flap retractor. The surgeon then activates and controls the irrigation and aspiration functions of LaFaci by depressing the momentary, variable (linear) foot switch located in the AIA foot control.

Only 1 to 2 seconds of irrigation is normally required. Immediately following, the surgeon simultaneously ceases irrigation/aspiration and moves the platform on the controlled course observing the corneal flap sliding from the platform and onto the stromal bed.

Contact Information

The LaFaci system received FDA 510 (k) clearance in May 2004. To learn more about the system, call (337) 267-1153 or e-mail info@lafacilasik.com.