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Cover Focus | Sep 2016

Not Yet Commercially Available: Should I Invest?

Marketing considerations with a new device.

Patients increasingly request laser surgery, even for cataract removal. For many patients, lasers represent high technology and precision. They have heard about laser use in cataract surgery, and they want that for their own eyes.

Up to now, femtosecond laser technologies have not really treated the cataract. In laser-assisted cataract surgery (LACS), the femtosecond laser can make the incisions, cut the capsulotomy, and even fragment the nucleus, but it does not take out the lens material. On top of that, femtosecond lasers are quite costly to purchase, and the disposables are expensive. And, despite the added precision, there is divided opinion about whether the laser technology actually benefits the patient over and above the excellent results seen today with traditional ultrasound phacoemulsification.

These are some of the reasons I never purchased a femtosecond laser but instead recently invested in a nanosecond laser for cataract surgery. The Cetus Nano Laser (A.R.C. Laser) performs 100% photofragmentation of the nucleus with potential for real advantages over ultrasound. In comparison with ultrasound, the laser disburses only 5% of the energy into the eye.1 Additionally, it has been shown that visual recovery is faster, with less loss of endothelial cells and less change in the morphology of endothelial cells compared with ultrasound.2 On top of these clinical advantages, the nanosecond laser is less expensive than femtosecond lasers, both in initial investment and in ongoing prices per case.

For all of these reasons, I became interested in obtaining a nanosecond laser, both as a clinical and as a marketing tool. Even though the laser will not be made widely available by the company until 2017, I was able to obtain one for my practice, and, since this past August, it has made a big difference in patients’ perceptions of my practice.

In order to educate myself about this technology, I went to observe the surgery of Gangolf Sauder, MD, of Stuttgart, Germany, who has perhaps the most clinical experience with the Cetus laser. I was pleased to see that the nanosecond laser is quite effective with medium-grade cataract, although it is less so with very hard cataracts, of approximately lens opacification classification system grade 3 or greater.

As far as a learning curve, one’s surgical procedure does not have to change. I use a small-incision chopping technique, and then once the nucleus has been chopped I emulsify the pieces of the lens with the nanosecond laser. So my approach to surgery, which I described in two earlier articles (see Blind Chopping: Managing Small Pupils Without Pupil-Expanding Devices, September 2013, http://crstodayeurope.com/2013/09/blind-chopping-managing-small-pupils-without-pupil-expanding-devices, and Small-Incision Bimanual Phaco Chop, April 2008, http://crstodayeurope.com/2008/04/0408_14.php/), has not changed. In my experience after 200 cases, I can confirm that most eyes are calm on day 1 postoperative. Patients’ visual recovery is faster, and there is only a moderate loss of endothelial cells. However, in the beginning, I had to cope with some ruptures of the posterior capsule.

The machine has a small footprint, so it can be placed on top of or next to the vitrectomy-phacoemulsification system. The laser fiber connects to the vitrectomy output of the system, and that provides the pulses to the laser. The laser works only in cooperation with the irrigation and aspiration system of the phaco machine.

As mentioned above, I purchased the nanosecond laser as a marketing tool also. Patients want laser cataract surgery, and I wanted to distinguish my practice from others around me that offer only femtosecond LACS. I am convinced of the clinical usefulness of the nanosecond laser; however, it does not efficiently address the hardest of cataracts, as it take too much time to ablate the lens. This often means that patients end up with corneal edema. But still, patients know that I offer laser cataract surgery, and, even if they do not qualify for that surgery themselves, I can still provide excellent surgical outcomes for them with traditional ultrasound phaco. Because the laser is part of my phaco machine, it is not intended to replace phacoemulsification. I am also told that future iterations of the system will have the capability to remove harder cataracts.

At the same time, while this technology distinguishes me from my competitors, it also costs me much less than a femtosecond laser would. The machine cost me a little more than 70,000, but this is much less than the 350,000 or 400,000 that companies charge for a femtosecond laser. Further, the disposables cost about 55 per eye, which is, again, much less than the 350 that some companies dare to ask for their disposables for the femtosecond laser. With the nanosecond laser, the whole procedure can be performed in a fully disposable way, and it is the only cataract procedure today that can be carried out completely with disposable products. This will minimize the risk of infections. Additionally, there is no click fee, as there are for many laser systems in the United States. So, in buying this machine, I have obtained an affordable laser for cataract surgery that sets me apart from all the competing practices in my region.

Up to now, the Cetus device has been placed only in selected centers in Europe. I will be involved, along with these other centers, in a European multicenter study to build on the work of Kanellopoulos,1 Mastropasqua,2 and Tanev,3 regarding energy distribution in the eye, time to visual recovery, and endothelial cell preservation. We will assess, in a larger number of patients, the effect of the laser on loss of and changes in endothelial cells, in comparison with ultrasound. We hope to show that the nanosecond laser is an effective device with no additional complications compared with standard-of-care phacoemulsification. I look forward to sharing those results at a future time. n

1. Kanellopoulos AJ, Dodick JM, Brauweiler P, Alzner E. Dodick photolysis for cataract surgery: Early experience with the Q-switched neodymium:YAG laser in 100 consecutive patients. Ophthalmology. 1999;106:2197-2202.

2. Mastropasqua L, Mattei PA, Toto L. All-laser cataract surgery with femtosecond and nanosecond devices. CRST Europe. 2016;2:26-28.

3. Tanev I, Tanev V, Kanellopoulos AJ. Nanosecond laser-assisted cataract surgery: Endothelial cell study. J Cataract Refract Surg. 2016;42(5):725-730.

Jérôme C. Vryghem, MD
• Medical Director, Brussels Eye Doctors, Belgium
• Member, CRST Europe Editorial Board
• Financial interest: None acknowledged