Femto Cataract Surgery: Is it Ready for Prime Time?
Even impressive technology can fall short if it adds an onerous financial burden.
The lust for money has forever plagued the human condition. As insurance payments for cataract surgery have decreased over the years, this has compelled surgery centers to seek additional revenue streams. Enter femtosecond cataract surgery and “premium” IOLs, both of which come with large out-of-pocket costs for the patient, who is in almost all cases a senior citizen. While there are indeed many people ecstatic with their vision with so-called premium IOLs, a substantial amount of others are frustrated with their compromised vision from these same lens implants. When outcomes are highly variable and the price tag is high, doctors have a duty to be conservative in our recommendations.
Drs. Melton, Thomas and Vollmer expand on their commentary about FLACS in response to previous letters. Click image to enlarge. |
We raised such concerns last year in the 2021 edition of our annual publication, Clinical Perspectives on Patient Care—and were taken to task in letters to the editor published in the October 2021 and November 2021 issues. Among other things, it was argued that because we are generalists rather than specialists in surgical comanagement, our impressions matter less than those with direct experience. We wish to delve into the topic some more to share the thoughts of surgeons on the front lines as well as our take on what these experts have been telling us, anecdotally and in peer-reviewed journals.
Numerous studies have found that femto and traditional phaco yield virtually clinically equivalent outcomes. The enabling reasoning offered by surgeons who promote these products and services is that “premium” IOLs that aim to correct astigmatism or presbyopia are a precise technology and must be placed in the eye with equal precision—thus the “need” for femto-assisted cataract surgery. A cataract surgeon at a prestigious medical center recently said to an ophthalmologist friend of ours, “femto is a device that prints money!”
The technology of “premium” IOLs may not be in its infancy, but it is still in its adolescence. Postoperative glare, halos and inadequate near vision correction are all so widespread that they require aggressive pre-op counseling of patients just to keep expectations somewhat reasonable. Ultimately, this technology may very well become standard of care, but such is not the case currently. I (Dr. Thomas) recently had a consultation with a lady who had been “sold” a $4,000-per-eye surcharge from a slick-talking “premium” cataract surgeon in a large city. One of our surgeons, who performs standard phaco and standard monofocal IOL implantation, was consulted at my request. This lady is now thrilled with her vision and thanked me profusely for saving her $8,000!
In a point-counterpoint debate that took place at the 2021 American Society of Cataract and Refractive Surgery annual meeting, one surgeon stated that his femto laser broke down after over one thousand cases, forcing a return to manual surgery. “What I found was that we were doing one less eye per hour with femto,” he was quoted as saying. “A little more anesthesia and pre-treatment with NSAIDs also were required for femto. Manual surgery is more efficient and decreases the cost for equivalent outcomes.”1 In a follow-up personal correspondence with this surgeon, he stated, “Even after doing one thousand consecutive femto cases, I could still find no cogent reason to continue. It’s a costly burden at best, and I haven’t done one in years.”
International Voices Join The ChorusIf the above-quoted papers aren’t enough to document the serious misgivings that many in the ophthalmology community have, there are plenty more available to those who want to look. Here are a few from our colleagues overseas: • A retrospective study of 50 FLACS and 50 conventional phaco surgeries performed in Egypt concluded: “Femtosecond laser-assisted cataract surgery was a safe and precise procedure, but enhanced visual outcomes only minimally when compared to conventional cataract surgery in experienced hands. Both FLACS and manual surgeries can achieve high efficiency, predictability and safety with slight superior outcomes in FLACS.”1 • In a cost effectiveness study conducted in the UK, research found that FLACS is “non-inferior” to phaco cataract surgery (PCS) in terms of vision and safety. While FLACS did clear that rather low bar, it was not considered cost effective enough to recommend. “We did not find evidence for a change in practice to adopt FLACS in preference to PCS,” the authors stated. In a summary intended for the public, they explained it as follows: “We found that the outcomes were almost identical for eyesight, quality of life and complications. Overall, the evidence suggests that the new technique is not worth the additional costs.”2 • A study of 704 eyes and 685 PCS eyes conducted for the French Ministry of Social Affairs and Health concluded: “Despite its advanced technology, femtosecond laser was not superior to phacoemulsification in cataract surgery and, with higher costs, did not provide an additional benefit over phacoemulsification for patients or healthcare systems.”3 1. Shaheen MS, AbouSamra A, Helaly HA, et al. Comparison Between Refractive Outcomes of Femtosecond Laser-Assisted Cataract Surgery and Standard Phacoemulsification. BMC Ophthalmology. 2020;20:1. |
Thumbs Down from the Academy
Defenders will argue that, in their centers, results are fantastic and patients are elated. That surely is true in some places, but we think it’s very telling that femto cataract has not yet been endorsed by the largest and most prestigious organization in ophthalmology. In October 2021, the American Academy of Ophthalmology released its latest position paper on cataract surgery, which states:2
“Femtosecond laser-assisted cataract surgery (FLACS) increases the circularity and centration of the capsulorhexis and the precision of the corneal incisions. It may also reduce the amount of ultrasonic energy required to remove a cataract. However, the technology is not yet cost-effective, and the overall risk profile and refractive outcomes have not been shown to be superior to that of standard phacoemulsification.”
“New technology in cataract surgery, including the use of advanced technology IOLs and femtosecond lasers, represents an increased out-of-pocket expense for cataract patients. Currently, these technologies are used in a small portion of total cases, but their use is expected to increase over the coming years. Also, [while] some benefits of new technology are clear, others remain ambiguous. Their use does add to the patient’s economic healthcare burden.”
There you have it: the voice of organized ophthalmology in America says FLACS is not, in fact, ready for prime time.
A previous letter to the editor noted that American journals and surgeons represent the gold standard for outcomes and interpretation of femto’s surgical merit, so let’s look at a few.
An article published in JCRS in 2020 concludes: “Both femto and phaco are effective and safe. Femto requires less ultrasonic energy and a more precise treatment. However, mid-term visual acuity did not show any difference between both methods.”3
In the October 2019 issue of AJO, we find the following quote: “Our study supports the well established similarity between femto and phaco with regard to visual and refractive outcomes in a very large, consecutive cohort. However, our results support the potential role for femto in more difficult cases, although large randomized studies in such cases are needed to further delineate this trend. Surgeon experience and comfort, patient preference and economic considerations remain critical factors of consideration for the choice of cataract surgery modality.”4
An article found in the August 2020 issue of Ophthalmology offers these conclusions: “The results of this trial with three-month postoperative data found that phaco is as good as femto in terms of vision, patient-reported health and safety outcomes at three months. Longer term outcomes in terms of clinical and cost-effectiveness are awaited. Additional randomized clinical trial data and meta-analysis are required to further investigate possible differences between the surgical methods because of the low complication rates and apparent similar efficacy.”5
Our Take on Femto
According to a preponderance of the literature, the advantage of “premium” IOLs and femtosecond surgery is evolving. FLACS is definitely no worse than conventional phaco and we do see the value it can offer in astigmatism reduction at the time of cataract surgery—corneal incisions can indeed be made very precisely with the laser. For patients with endothelial compromise, the femto laser allows for less ultrasound energy to be used. Dense cataracts can be chopped more easily with the laser. Some premium IOL patients get marginally better visual outcomes.
But none of that addresses FLACS’s added cost, especially in light of its only modest clinical gains. Based on the humanitarian principle of caring for others in a manner in which you would like to be cared for, we feel femto and “premium” IOLs are not delivering a premium experience for most patients.
For many years, there has been a quest for reducing healthcare costs to American citizens. With finite healthcare resources, it is our responsibility to practice cost-effective, evidence-based medicine. Need more be said?
—Randall Thomas, OD, MPH
Concord, NC
Ron Melton, OD
Charlotte, NC
Patrick Vollmer, OD
Shelby, NC
1. 2021 American Society of Cataract and Refractive Surgery, Las Vegas, NV. As quoted in “LACS vs. Manual Surgery,” EuroTimes, October 1, 2021. Available at www.eurotimes.org/lacs-vs-manual-cataract-surgery.
2. Miller KM, Oetting TA, Tweeten JP, Carter K, Lee BS, Lin S, Nanji AA, Shorstein NH, Musch DC; American Academy of Ophthalmology preferred practice pattern cataract/anterior segment panel. Cataract in the Adult Eye Preferred Practice Pattern. Ophthalmol. 2022;129(1):1-126.
3. Kolb CM, Shajari M, Mathys L, Herrmann E, Petermann K, Mayer WJ, Priglinger S, Kohnen T. Comparison of femtosecond laser-assisted cataract surgery and conventional cataract surgery: a meta-analysis and systematic review. J Cataract Refract Surg. 2020;46(8):1075-85.
4. Nithiandan H, Jegatheeswaran V, Dalal V, et al. Refractive laser-assisted cataract surgery versus conventional manual surgery: comparing efficacy and safety in 3,144 eyes. Am J Ophthalmol. 2019;206:32–39.
5. Day AC, Burr JM, Bennett K, et al. Femtosecond Laser-assisted cataract surgery versus phacoemulsificalion cataract surgery (FACT). Ophthalmol. 2020;127:1012-19.