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Newest technology may not be the best fit for all surgeons
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In my last commentary, which accompanied part 1 of the round table discussion on femtosecond laser-assisted cataract surgery in the Dec. 10 issue, I made the argument that it is now possible for nearly every cataract surgeon in the continental United States to access a femtosecond laser one way or another. In this commentary, I would like to share my current thoughts regarding the utility, cost and politics of femtosecond laser-assisted cataract surgery, or FLACS. I suspect my comments will be controversial to some, and for that I again apologize. I would also like to disclose that I consult or have consulted for several companies involved in FLACS, including Alcon/LenSx, AMO, Bausch + Lomb, Lensar, Sightpath and Precision Lens.
The femtosecond laser is, to me, an extremely precise computer-driven scalpel. It is incumbent on the surgeon and his or her assistants to formulate a surgical plan, program the laser and properly dock it to the patient’s eye. However, once the treatment is started, the surgeon’s primary responsibility, other than reassuring the patient and helping to steady the eye, is to monitor the treatment and abort if something untoward occurs, such as a loss of suction.
While this might sound simple, I personally did not find that FLACS was less stressful or made the surgery easier. Significant skill is required to perform a flawless FLACS, both during the laser treatment and the subsequent cataract removal and lens implantation. For me, there was a learning curve, and about 25 cases were required before I was comfortable, and my skills and judgment continued to increase to as many as 100 cases. In addition, FLACS definitely did not make my surgery faster or less expensive, with each case at my volume costing me about $750.
I performed FLACS using a two-room approach and found that the femtosecond laser room time was pretty much the same as the cataract and lens implant time — usually 6 to 10 minutes depending on the complexity of the case for a total of 15 to 20 minutes for most patients. So, in addition to the cost in dollars, there was a cost in time, and because time is money for most surgeons in most settings, this cost needs to be borne by the patient or surgeon.
In the U.S., this patient-shared responsibility for the extra cost is only allowed if the patient has opted for refractive cataract surgery that includes the management of astigmatism. I personally think this requirement is inappropriate and perhaps even unconstitutional, as in my perhaps controversial opinion, an American citizen should be allowed to spend his own money as he sees fit, including on access to advanced medical technology such as FLACS. After all, we are purported to be the “the land of the free and the home of the brave,” and our citizens are to be guaranteed the right to “life, liberty and the pursuit of happiness.” To me, this should include the right to purchase any U.S. Food and Drug Administration-approved treatment that a patient and his doctor believe will be in the patient’s best interests.
Unfortunately, today, if a patient with a complex cataract such as a hypermature lens, loose or missing zonules, Fuchs’ dystrophy or an extremely dense cataract wishes his surgeon to use a femtosecond laser, he cannot be charged and the surgeon must personally bear the cost. At $750 per treatment, this is significantly greater than the surgeon fee, putting the ophthalmologist who believes FLACS would be safer for his patient in a very difficult position. Should he do what he thinks is right for the patient and risk bankruptcy, charge the patient and risk the wrath of regulatory bodies, or compromise and do his best with manual methods? To me, this is ethically and morally wrong and deserves correction. Simply allowing the patient and doctor to make the decision in the patient’s best interests and when affordable, allowing the patient to share in the cost, would solve this unjust problem.
On to the merits of the procedure. FLACS can make the primary and secondary incisions, perform standard or intrastromal corneal relaxing incisions, create an anterior and/or posterior capsulotomy, and incise or fragment the nucleus. I am well aware of the published literature, but it is not my goal in these commentaries to generate a review article. I will just share a few impressions of an early although relatively low-volume adopter.
The primary and secondary incisions I can make with a high-quality metal or gem blade are superior to those that are generated by the laser. I like the potential promise of generating a more reproducible incision one case to another and one surgeon to another with FLACS, but so far I prefer to make these incisions manually.
The capsulotomy generated by the laser is close to perfection, and I cannot do as well manually. I have not experienced even one anterior capsular rim tear using the LenSx laser (Alcon) despite using hydrodissection and a supracapsular phacoemulsification approach in most patients. The capsulotomies look great on the table and postop, but the eventual impact on spherical refractive outcomes is at best subtle. The idea of revisiting primary posterior capsulotomy with FLACS is intriguing, but to date, I have not personally done any. If proven safe and effective, capsular opacity will be history for the patient who can access FLACS, which is a very exciting potential opportunity.
Corneal relaxing incisions are magical and beautiful to the surgeon and referring doctor’s eye when viewed at the slit lamp. Careful attention to axis of placement, length, depth and optical zone is as critically important as it is when using a diamond knife. I found an 8.5-mm optical zone, 85% depth and incisions no longer than 60° to be very effective. Using a Mastel keratoscope to pre-mark the steeper and flatter meridian, intraoperative aberrometry to fine-tune the spherical IOL power selection and astigmatism incisions (opening and extending with a diamond knife when appropriate), in a series of 25 consecutive cases with up to 3 D of astigmatism, I achieved 92% within 0.5 D of target in a group of non-toric multifocal IOL patients. These are the best refractive outcomes I have ever generated, but it required a full-court press of technology. Still, I prefer a toric IOL whenever possible, and with the recent recommendation for approval of a toric multifocal in the U.S., I believe the indications for a corneal relaxing incision will be rare. It is usually an on-axis incision for low astigmatism, which I perform with a blade, or a toric IOL starting at 0.75 D of cylinder. So a great corneal relaxing incision is, for me, of declining value.
On to nuclear fragmentation. For the denser lens, this is a useful adjunct. I could not personally see a meaningful difference in corneal clarity at 1 day postop, but phaco times, energy utilized and fluid through the eye are reduced, and this is likely a good thing. On the negative side, all patients have some subconjunctival hemorrhage, but this was not a complaint generator for me. The pupil often constricts, significantly in some younger patients, but for me it redilated with intracameral non-preserved Xylocaine (lidocaine) and epinephrine. I did not have any major complications in about 100 eyes, but if I had continued to grow my series, I am sure I would encounter them.
I like FLACS, found it fun to do, and was pleased with the aesthetics of the anterior capsulotomy and corneal relaxing incisions. Unfortunately, I personally could not reach the critical mass of cases required to justify acquiring a laser, especially when its use is restricted to refractive cataract surgery and I cannot offer it to all-comers.
I am looking forward to the day when the laws and economics improve, and I am confident they will. Until then, I remain a manual cataract surgeon and am comfortable that my skills afford my patients an excellent outcome. Still, if FLACS were free, I would be using it on a lot, perhaps most, of my patients. Such is the nature of today’s ophthalmology practice. As the song lyrics say, “You can’t always get what you want.”