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<h1 class="meta-article-title ">Femtosecond Laser-Assisted Cataract Surgery—Conclusive Evidence of Lack of Incremental Value</h1>
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<span class="wi-fullname brand-fg"><a href="/searchresults?author=Oliver+D.+Schein&q=Oliver+D.+Schein" rel="nofollow" target="_blank">Oliver D. Schein, MD, MPH<sup>1</sup></a></span>
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<div class="meta-author-name"><sup>1</sup>Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland</div>
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<span class="meta-citation-journal-name">JAMA Ophthalmol. </span><span class="meta-citation"> 2023;141(7):629-630. doi:10.1001/jamaophthalmol.2023.1828</span>
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<div class="related-article-title sb-tc">Cost Utility and Value of Information Analysis of Femtosecond Laser–Assisted Cataract Surgery</div>
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<div class="related-article-authors">Antoine Bénard, MD, PhD; Remi Sitta, MSc; Antoine Pierre Brezin, MD, PhD; Beatrice Cochener, MD, PhD; Dominique Monnet, MD, PhD;
Philippe Denis, MD, PhD; Pierre-Jean Pisella, MD, PhD; Nathalie Hayes, MSc; Cedric Schweitzer, MD, PhD; FEMCAT Study Group; Laurent Piazza; Nicolas Georges; Stéphanie
Roseng; Anne Gimbert; Sophie Regueme; Jérome Galet; Fabien Daniel; Joseph Colin; David Touboul; Olivier Chatoux; Emilie Bardet; Catherine Bourreau;
Romain Nicolau; Margaux Guillard; Catherine Cochard; Emilie Merce; Florence Galliot; Laurent Kodjikian; Minh Nguyen; Vincent Fortoul; Jean Rateau; Guillaume Vandenmeer;
Thomas Habay; Jean-Louis Arné; Jean-Jacques Sarragoussi ; Cati Albou-Ganem</div>
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<p class="para"><span class="drop-cap">B</span>énard and colleagues<sup><a href="#eic230023r1" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">1</a></sup> report a detailed cost-utility study of femtosecond
laser-assisted cataract surgery (FLACS) in comparison with standard phacoemulsification cataract surgery (PCS) and did not find FLACS to be cost-effective. FLACS was introduced into cataract surgical practice about 12 years ago
with much excitement and anticipation. Here was an elegant procedure with the promise of greater precision and enhanced clinical outcomes compared with conventional ultrasound phacoemulsification for cataract surgery, the most
performed operation. For many years, achievement of that promise was claimed based on small studies from enthusiastic early adopters. However, the strength of evidence showing no incremental benefit is now substantial. In fact, I
believe that there are now more high-quality clinical research studies assessing the comparative outcomes of these competing procedures than available for any other ophthalmic surgical procedure in recent decades. In addition to
large and well-controlled observational studies, such as that from a European registry,<sup><a href="#eic230023r2" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">2</a></sup> there have been 2 recent,
well-powered, randomized clinical trials (RCTs) with similar results. From the UK, Day et
al<sup><a href="#eic230023r3" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">3</a></sup><sup>,<a href="#eic230023r4" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">4</a></sup>
reported 3- and 12-month results of an RCT with 785 participants randomly assigned to either FLACS or PCS and found FLACS to be noninferior, with no difference in masked assessments of unaided distance vision, corrected visual
acuity, patient-reported outcomes, and achievement of the refractive target within one-half diopter. From France, Schweitzer et
al<sup><a href="#eic230023r5" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">5</a></sup> reported their RCT in which 907 participants were also masked using a sham laser procedure for those randomly
assigned to PCS. No statistically significant difference in surgical success, defined as a composite of 4 outcomes at 3 months after surgery (absence of severe complication, best-corrected visual acuity, an absolute refractive
error of 0.75 diopters or less, induced corneal astigmatism of 0.5 diopters or less, and axis of astigmatism change of 20° or less) was found. Additionally, no statistically significant difference in the outcomes of each of their
individual composite measures was noted. Not surprisingly, in the absence of demonstrated clinical benefit, FLACS was not found to be cost-effective in either the UK or the French study.</p>
<a class="article-section-id-anchor" id="249124724"></a>
<p class="para">In the domain of pharmaceuticals, we have come to expect and demand the performance of several well-run RCTs using clinically relevant outcomes before concluding that one drug is superior to another for a specific
indication. Sometimes, when 2 drugs are equivalent in efficacy, one might still be considered superior based on a lower adverse effect profile, reduced cost, or perhaps a shorter treatment course. However, when 2 surgical
procedures are equivalent in rates of both favorable clinical outcomes and complications, there is only 1 obvious conclusion when one costs more.</p> <a class="article-section-id-anchor" id="249124725"></a>
<p class="para">The concept of value in health care certainly depends on one’s perspective, which sometimes may differ depending on whether the perspective is that of an insurance payer, a population balancing competing demands with
a fixed budget, a patient, or a clinician. I like the very pragmatic and widely recognized approach proffered by Porter and
Lee,<sup><a href="#eic230023r6" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">6</a></sup> which defines value as health outcomes achieved that matter to patients relative to the cost of achieving those
outcomes. What do most patients getting cataract surgery want? That is not a difficult question. They want an uncomplicated course with the achievement of a specified visual target in a setting that is safe and comfortable. They
also want to limit out-of-pocket costs. In many ophthalmology practices, patients are flooded with messaging—some overt and some indirect—that the choice of FLACS over PCS is one of premium vs ordinary or optimal vs acceptable.
Sometimes these messages are conflated, at least in patients’ minds, with intraocular lens choice. Not infrequently I hear from patients seeking second opinions that they thought they had to choose FLACS to achieve the best
outcome, have their astigmatism addressed, or get the full benefit of an implant with extended range of focus attributes. The prevalence of such messaging and its misunderstanding raises concerns about professionalism.</p>
<a class="article-section-id-anchor" id="249124726"></a>
<p class="para">In the UK or France where the government-funded health care systems supported first-rate research into the relative benefits of FLACS vs PCS, the estimated per case difference in costs was in the range of $200 to
$350. Given the results of the research by our colleagues in France and the UK, it remains unlikely that FLACS in its current incarnation would be funded by federal or private insurers in the US. Ironically, were that to happen,
the rate of FLACS procedures in the US would likely fall precipitously. From the perspective of the surgeon, an extra $300 per case would probably not justify the extra time and expense of FLACS, especially in the known absence of
clinical benefit.</p> <a class="article-section-id-anchor" id="249124727"></a>
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<p class="authorInfoSection"><strong>Corresponding Author:</strong> Oliver D. Schein, MD, MPH, Wilmer Eye Institute, Johns Hopkins University School of Medicine, 800 N Wolfe St, Wilmer 120, Baltimore, MD 21287-9012
(<a href="mailto:oschein@jhmi.edu" target="_blank">oschein@jhmi.edu</a>).</p>
<p class="parapublished-online"><strong>Published Online:</strong> May 18, 2023. doi:<a href="https://jamanetwork.com/article.aspx?doi=10.1001/jamaophthalmol.2023.1828" target="_blank">10.1001/jamaophthalmol.2023.1828</a></p>
<p class="parafinancial-disclosure"><strong>Conflict of Interest Disclosures:</strong> None reported.</p> <a class="article-section-id-anchor" id="249124728"></a>
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2013;91(10):50-70.<a class="google-scholar-ref-link" href="https://scholar.google.com/scholar_lookup?title=The%20strategy%20that%20will%20fix%20health%20care.&author=M%20Porter&author=T%20Lee&publication_year=2013&journal=Harv%20Bus%20Rev&volume=91&pages=50-70" target="_blank" xmlns:helper="urn:XsltStringHelper">Google Scholar</a>
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<a href="#" class="comment-expand-all fw-b right text-small sb-sc">EXPAND ALL</a>
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<div class="comment-item--date-submitted">July 21, 2023</div>
<div class="comment-item--title thm-col fw-b sb-pc">Does the corneal endothelium matter to the patient?</div>
<div class="comment-item--author">
<span class="author-name fw-b">Wm Prendergast, MD</span> | Clincal Asst. Prof. Ophthalmology, OHSU, retired
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<span class="comment-item--text-limited ellipsis">The one thing that I find missing in this study, others I've seen and those you reviewed is the impact on the corneal endothelium. If and when there is a serious one in the
course of cataract surgery, the clinical complications that ensue often occur well beyond the one year follow-up range of most of these studies. Certainly a seriously negative impact on the corneal epithelium is going to be
uncommon if not rare. And more likely with the less experienced surgeon, resident in training, brunescent nucleus, etc.. But it is at these margins that I</span>
<span class="comment-item--text-remaining"> wonder if the femtosecond laser doesn't show its value with its potential for increased speed and precision.</span>
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Invited Commentary
May 18, 2023
FEMTOSECOND LASER-ASSISTED CATARACT SURGERY—CONCLUSIVE EVIDENCE OF LACK OF
INCREMENTAL VALUE
Oliver D. Schein, MD, MPH1
Author Affiliations Article Information
* 1Wilmer Eye Institute, Johns Hopkins University School of Medicine,
Baltimore, Maryland
JAMA Ophthalmol. 2023;141(7):629-630. doi:10.1001/jamaophthalmol.2023.1828
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* Original Investigation
Cost Utility and Value of Information Analysis of Femtosecond Laser–Assisted
Cataract Surgery
Antoine Bénard, MD, PhD; Remi Sitta, MSc; Antoine Pierre Brezin, MD, PhD;
Beatrice Cochener, MD, PhD; Dominique Monnet, MD, PhD; Philippe Denis, MD,
PhD; Pierre-Jean Pisella, MD, PhD; Nathalie Hayes, MSc;
Cedric Schweitzer, MD, PhD; FEMCAT Study Group; Laurent Piazza; Nicolas
Georges; Stéphanie Roseng; Anne Gimbert; Sophie Regueme; Jérome Galet;
Fabien Daniel; Joseph Colin; David Touboul; Olivier Chatoux;
Emilie Bardet; Catherine Bourreau; Romain Nicolau; Margaux Guillard;
Catherine Cochard; Emilie Merce; Florence Galliot; Laurent Kodjikian; Minh
Nguyen; Vincent Fortoul; Jean Rateau; Guillaume Vandenmeer; Thomas Habay;
Jean-Louis Arné; Jean-Jacques Sarragoussi ; Cati Albou-Ganem
Bénard and colleagues1 report a detailed cost-utility study of femtosecond
laser-assisted cataract surgery (FLACS) in comparison with standard
phacoemulsification cataract surgery (PCS) and did not find FLACS to be
cost-effective. FLACS was introduced into cataract surgical practice about 12
years ago with much excitement and anticipation. Here was an elegant procedure
with the promise of greater precision and enhanced clinical outcomes compared
with conventional ultrasound phacoemulsification for cataract surgery, the most
performed operation. For many years, achievement of that promise was claimed
based on small studies from enthusiastic early adopters. However, the strength
of evidence showing no incremental benefit is now substantial. In fact, I
believe that there are now more high-quality clinical research studies assessing
the comparative outcomes of these competing procedures than available for any
other ophthalmic surgical procedure in recent decades. In addition to large and
well-controlled observational studies, such as that from a European registry,2
there have been 2 recent, well-powered, randomized clinical trials (RCTs) with
similar results. From the UK, Day et al3,4 reported 3- and 12-month results of
an RCT with 785 participants randomly assigned to either FLACS or PCS and found
FLACS to be noninferior, with no difference in masked assessments of unaided
distance vision, corrected visual acuity, patient-reported outcomes, and
achievement of the refractive target within one-half diopter. From France,
Schweitzer et al5 reported their RCT in which 907 participants were also masked
using a sham laser procedure for those randomly assigned to PCS. No
statistically significant difference in surgical success, defined as a composite
of 4 outcomes at 3 months after surgery (absence of severe complication,
best-corrected visual acuity, an absolute refractive error of 0.75 diopters or
less, induced corneal astigmatism of 0.5 diopters or less, and axis of
astigmatism change of 20° or less) was found. Additionally, no statistically
significant difference in the outcomes of each of their individual composite
measures was noted. Not surprisingly, in the absence of demonstrated clinical
benefit, FLACS was not found to be cost-effective in either the UK or the French
study.
In the domain of pharmaceuticals, we have come to expect and demand the
performance of several well-run RCTs using clinically relevant outcomes before
concluding that one drug is superior to another for a specific indication.
Sometimes, when 2 drugs are equivalent in efficacy, one might still be
considered superior based on a lower adverse effect profile, reduced cost, or
perhaps a shorter treatment course. However, when 2 surgical procedures are
equivalent in rates of both favorable clinical outcomes and complications, there
is only 1 obvious conclusion when one costs more.
The concept of value in health care certainly depends on one’s perspective,
which sometimes may differ depending on whether the perspective is that of an
insurance payer, a population balancing competing demands with a fixed budget, a
patient, or a clinician. I like the very pragmatic and widely recognized
approach proffered by Porter and Lee,6 which defines value as health outcomes
achieved that matter to patients relative to the cost of achieving those
outcomes. What do most patients getting cataract surgery want? That is not a
difficult question. They want an uncomplicated course with the achievement of a
specified visual target in a setting that is safe and comfortable. They also
want to limit out-of-pocket costs. In many ophthalmology practices, patients are
flooded with messaging—some overt and some indirect—that the choice of FLACS
over PCS is one of premium vs ordinary or optimal vs acceptable. Sometimes these
messages are conflated, at least in patients’ minds, with intraocular lens
choice. Not infrequently I hear from patients seeking second opinions that they
thought they had to choose FLACS to achieve the best outcome, have their
astigmatism addressed, or get the full benefit of an implant with extended range
of focus attributes. The prevalence of such messaging and its misunderstanding
raises concerns about professionalism.
In the UK or France where the government-funded health care systems supported
first-rate research into the relative benefits of FLACS vs PCS, the estimated
per case difference in costs was in the range of $200 to $350. Given the results
of the research by our colleagues in France and the UK, it remains unlikely that
FLACS in its current incarnation would be funded by federal or private insurers
in the US. Ironically, were that to happen, the rate of FLACS procedures in the
US would likely fall precipitously. From the perspective of the surgeon, an
extra $300 per case would probably not justify the extra time and expense of
FLACS, especially in the known absence of clinical benefit.
Back to top
Article Information
Corresponding Author: Oliver D. Schein, MD, MPH, Wilmer Eye Institute, Johns
Hopkins University School of Medicine, 800 N Wolfe St, Wilmer 120, Baltimore, MD
21287-9012 (oschein@jhmi.edu).
Published Online: May 18, 2023. doi:10.1001/jamaophthalmol.2023.1828
Conflict of Interest Disclosures: None reported.
References
1.
Bénard A, Sitta R, Brezin AP, et al; FEMCAT Study Group. Cost utility
and value of information analysis of femtosecond laser-assisted cataract
surgery. JAMA Ophthalmol. Published online May 18, 2023.
doi:10.1001/jamaophthalmol.2023.1716
ArticleGoogle ScholarCrossref
2.
Manning S, Barry P, Henry Y, et al. Femtosecond laser-assisted cataract
surgery vs standard phacoemulsification cataract surgery: study from the
European Registry of Quality Outcomes for Cataract and Refractive Surgery. J
Cataract Refract Surg. 2016;42(12):1779-1790.
doi:10.1016/j.jcrs.2016.10.013PubMedGoogle ScholarCrossref
3.
Day AC, Burr JM, Bennett K, et al; FACT group. Femtosecond
laser-assisted cataract surgery vs phacoemulsification cataract surgery (FACT):
a randomized noninferiority trial. Ophthalmology. 2020;127(8):1012-1019.
doi:10.1016/j.ophtha.2020.02.028PubMedGoogle ScholarCrossref
4.
Day AC, Burr JM, Bennett K, et al; FACT trial group. Femtosecond
laser-assisted cataract surgery compared with phacoemulsification cataract
surgery: randomized noninferiority trial with 1-year outcomes. J Cataract
Refract Surg. 2020;46(10):1360-1367.
doi:10.1097/j.jcrs.0000000000000257PubMedGoogle ScholarCrossref
5.
Schweitzer C, Brezin A, Cochener B, et al; FEMCAT study group.
Femtosecond laser-assisted versus phacoemulsification cataract surgery
(FEMCAT): a multicentre participant-masked randomised superiority and
cost-effectiveness trial. Lancet. 2020;395(10219):212-224.
doi:10.1016/S0140-6736(19)32481-XPubMedGoogle ScholarCrossref
6.
Porter M, Lee T. The strategy that will fix health care. Harv Bus Rev.
2013;91(10):50-70.Google Scholar
Comment
1 Comment for this article
EXPAND ALL
July 21, 2023
Does the corneal endothelium matter to the patient?
Wm Prendergast, MD | Clincal Asst. Prof. Ophthalmology, OHSU, retired
The one thing that I find missing in this study, others I've seen and those you
reviewed is the impact on the corneal endothelium. If and when there is a
serious one in the course of cataract surgery, the clinical complications that
ensue often occur well beyond the one year follow-up range of most of these
studies. Certainly a seriously negative impact on the corneal epithelium is
going to be uncommon if not rare. And more likely with the less experienced
surgeon, resident in training, brunescent nucleus, etc.. But it is at these
margins that I wonder if the femtosecond laser doesn't show its value with its
potential for increased speed and precision.
CONFLICT OF INTEREST: None Reported
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CITATION
Schein OD. Femtosecond Laser-Assisted Cataract Surgery—Conclusive Evidence of
Lack of Incremental Value. JAMA Ophthalmol. 2023;141(7):629–630.
doi:10.1001/jamaophthalmol.2023.1828
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