New Microkeratomes Still Coming to the Market

The launch of the Rondo mechanical microkeratome (WaveLight AG, Erlangen, Germany), comes during a time of great hype for the femtosecond laser. Still, Mario Klafke, Director of Product Management for WaveLight AG, sees the equipment as a complement to the refractive surgery market and not as a competitor of femtosecond technology.

"The use [of femtosecond lasers and mechanical microkeratomes] in the world is split fairly evenly," Mr. Klafke said at the XXV Congress of European Society of Cataract and Refractive Surgeons (ESCRS) in Stockholm, Sweden. "Although everyone is talking about femtosecond, the price difference keeps these two technologies from reaching a competitive level. There is no chance that femtosecond technology will reduce to a price that can compete with the cost of mechanical microkeratomes," he said.

The WaveLight Rondo, which features an elevated suction ring to work in very narrow eyes and oscillation speeds of up to 9,000 rpm, was built for the best predictability, safety, and precision, according to the company.

The microkeratome's cutting technology works with linear feed motion and is connected to the console for a permanent closed-loop control of the motor parameters (eg, oscillation, feed motion, power). Reaching a maximum of 9,000 rpm and 2.8 mm per second, the oscillation and driving speed can be individually adjusted by the surgeon. The Rondo's unique blade positioning concept eliminates production tolerances and fixes every blade in the same position on the cutting head, which leads to predictable flap thicknesses. Additionally, it is the only microkeratome on the market that features waved slide rails to guide the blade during surgery, resulting in less friction and lower abrasion, according to company literature.

Luis A. Ruiz, MD, of Bogotá, Colombia, has used the Rondo on more than 40 eyes; Dr. Ruiz told CRST Europe in an e-mail interview, that the microkeratome is "easy to use, safe in the eye, and provides an excellent quality of cut." This is a common response from surgeons who are using the Rondo for the first time, Mr. Klafe added.

Because of the lower cost (?39,000), compared with femtosecond technology, WaveLight believes that Rondo will be a competitive solution, even in markets such as India, China, and South America, Mr. Klafke said. "The microkeratome offers the same results as a femtosecond, at a fraction of the price," he added.

In addition to the price value, the WaveLight Rondo's appeal is also found in its preloaded blade system (Figure 1), which eliminates the risk of contamination and keeps the blade sterile and sharp, Dr. Ruiz said. This concept helps to ensure that the "cutting edge is in good condition. It is impossible to touch or damage the blade, so the thickness of the cut is more precise and corresponds to the given measurement."

Dr. Ruiz noted that on the first postoperative day of his 40 original cases with the Rondo, his patients had the best visual acuity rates of any surgery he had ever performed.

HANDPIECE
For gentle procedures, the Rondo handpiece (Figure 2) can be preassembled to minimize contact time with the patient's eye. The handpiece weighs 107 g; its design enables monitoring of the complete cutting process. Additionally, the surgeon can determine flap size, thickness, and hinge position. Even larger flap diameters are possible, and the Rondo's safety system ensures a minimum hinge width, according to the company.

DOCUMENTATION SYSTEM
The Rondo also includes an optional end-to-end registration and documentation system (Figure 3). Before the flap cut, each component is unambiguously identified by its data matrix code. The code is scanned by the barcode scanner and then transferred to the console. An integrated card reader checks the blade code to ensure that the blade is an original and has not yet been used.

All scanned components are also listed on the console and documented for each individual treatment. An integrated printer allows on-the-fly printouts for documentation. Additionally, advanced suction technology results in low intraocular pressure during the suction and blade pass, according to the company.

A PLACE IN THIS WORLD
With these and other improvements, Mr. Klafke believes that conventional microkeratomes can continue to capture a major share of LASIK procedures worldwide. This fact, says Mr. Klafke, is found in the value and efficiency that conventional microkeratomes—like the WaveLight Rondo—offer.

Mario Klafke, is Director of Product Managment for WaveLight Laser Technologie AG, in Erlangen, Germany. He may be reached at mario.klafke@wavelight.com.

Luis A. Ruiz, MD, is Scientific Director at the Centro Oftalmologico Colombia, in Bogotá, Colombia. He states that he owns the patent for the automatic corneal shaper, which is used in the original Rondo. Dr. Ruiz may be reached at luisantonio.ruiz@gmail.com.