This article is more than 5 years old. Information may no longer be current.

Flapmaker single-use microkeratome found efficient

The plastic device compares well with a similar metal unit, according to a surgeon’s study.

ByMarvin L. Kwitko, MD

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

MONTREAL — The Flapmaker disposable microkeratome from Refractive Technologies is just as precise and consistent in creating corneal flaps during LASIK as the Moria LSK-One reusable microkeratome, according to a retrospective analysis of 150 eyes in 137 patients.

From 1995 to 1996, I used the metal LSK-One and have been very happy with it. When Refractive Technologies introduced a plastic, completely assembled disposable keratome in 1998, I purchased it to be used by the three or four occasional LASIK surgeons who used my laser center because one of the surgeons once dropped one of my metal keratomes, ruining it.

I began using it so I could instruct my colleagues. It turned out to have important features that convinced me to use it myself. The only question was if it produced a flap equal to the LSK-One reusable instrument, which was the first microkeratome Moria introduced. I had kept track of parameters of the thickness of the corneal flap and the host cornea, the dimensions of the flap and the quality of the flap when I used the LSK-One and now performed the same examinations with the Flapmaker.

I have performed close to 10,000 refractive surgery procedures since 1979. I have used various reusable microkeratomes and have done over 250 eyes with the Flapmaker.

The prevailing thought was that because the single-use device is made of plastic, it might not create as high a grade quality stromal bed or reproducible flap thickness. Our results showed that the actual dimension and thickness of the flap was just as predictable as what we achieved with the metal microkeratome. In fact, the actual qualitative assessment of the flap — how they looked to us, felt and acted as well as the actual bed — was just as good, if not better, than the reusable unit.

Consistent results

For the study, 75 eyes of 68 patients had been treated with the LSK-One manual linear keratome, and 75 eyes of 69 patients were treated with the automated disposable Flapmaker. Corneal flap thickness was measured by subtracting the intraoperative corneal bed thickness (after creating the flap) from the preoperative central corneal thickness using the Sonogage Corneo-Gage Plus 2 pachymeter.

The mean flap thickness using the reusable Moria manual LSK-One 160-µm head was 162 µm, with a standard deviation of 30 µm, ranging from 102 to 205 µm. When we calculated the average flap thickness with the automated Flapmaker 160 µm head, it was 163 µm, with a standard deviation of 24 µm ranging from 115 to 203 µm. The average flap thickness was basically identical between the two groups.

During my term as chairman of the Advisory Committee on the Excimer Laser for Health Canada, the committee evaluated the excimer laser from 1990 to 1995, when it was approved for use throughout Canada. I have advised the Canadian department to create another such committee to evaluate all of the new keratomes that are being sold in Canada.

Flapmaker features

The unit is pre-assembled with the microkeratome already engaged in the suction ring so there is no need to engage the keratome in the proper grooves of the suction ring just prior to making the cut, thus saving a step in the procedure of perhaps 10 to 15 seconds.

The keratome is engaged in a track; there are no gears that could get blocked with a lash or mucus or jam.

The company also provides keratomes with a narrower diameter (or footprint) for smaller or deeper set eyes, as well as keratomes of 130 µm, 160 µm, 180 µm and 200 µm. In this study, we used the 160-µm keratome.

The transparency of the suction ring allows visualization of a large blanching area of the limbus, which indicates suction has been achieved. Also, one can see the pupil dilate as vacuum stabilizes.

Ocular pressure is measured with a pneumotonometer.

The entire handpiece and cutting head is pre-sterilized, thus problems associated with sterilization are eliminated.

Diffuse lamellar keratitis cases are rare (one case in 2 years with this device). The rare event of transferring bacteria, viruses or fungi with a reusable keratome is eliminated.

When the suction release pedal is engaged, the pressure comes down gradually over about 5 seconds which is preferred physiologically over a sudden drop in intraocular pressure with some other keratomes.

For Your Information:

• Marvin L. Kwitko, MD, is an associate professor of ophthalmology at McGill University. He can be reached at 5591 Cote des Neiges, Suite 1, Montreal, PQ, H3T 1Y8, Canada; +(1) 514-735-1133; fax: +(1) 514-731-0651. Dr. Kwitko has no direct financial interest in the products mentioned in this article, nor is he a paid consultant for any companies mentioned.
• Moria Inc. can be reached at 4030 Skyron Drive, Unit G, Doylestown, PA 18901 U.S.A.; +(1) 215-230-7662; fax: +(1) 215-230-7670; e-mail: moriausa@ moriausa.com; Web site: www.moria-surgical.com.
• Refractive Technologies Inc. can be reached at 30799 Pinetree Rd., Suite 210, Cleveland, OH 44124 U.S.A.; +(1) 216-514-1914; fax: +(1) 216-514-1920.
• Sonogage, Inc. can be reached at 26650 Renaissance Parkway, Suite 3, Cleveland, OH 44122 U.S.A.; +(1) 216-464-1119; fax: +(1) 216-831-3444; e-mail: Flapmaker@ prodigy.net.