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The 25th Anniversary of Laser Vision Correction in the United States

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Laser Vision Correction (LVC) is an elective, self-pay and safe surgical procedure to correct myopia and hyperopia. Since FDA approval 25 years ago, there have been a progression of technological improvements leading to better outcomes and LVC is now one of the safest surgical procedures. With a potential pool of 50 million patients, 6000 trained ophthalmic surgeons regularly treating in over 1000 centers of which 65% are physician owned. Treatments remain low from an earlier peak of 1.4 million to less than 800,000 over last 10 years. The factors preventing patients undergoing surgery have not changed and include the cost of $2000 ± $1000 per eye and fear of laser surgery on their eyes. The latter is overcome by word of mouth referrals and positive social media messaging. In addition, press misinformation and lack of optometrists participating in co-management have not helped grow LVC procedures despite the positive results of the FDA's Patient Reported Outcomes with LASIK studies known as PROWL. The surgery is quick, and patients can be "in and out" in less than two hours with a rapid recovery, minimal postoperative restrictions and within 24 hours have 20/20 vision. Volume and price drives center and physician profitability with a scheduling capacity of two to four patients' treatments per hour. Laser vision correction and especially LASIK, remains the treatment of choice for myopic and hyperopic patients wanting to remove their dependency on glasses and contact lenses.
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PERSPECTIVES
The 25th Anniversary of Laser Vision Correction
in the United States
This article was published in the following Dove Press journal:
Clinical Ophthalmology
Stephen N Joffe
1,2
1
History of Medicine, Cedars-Sinai
Medical Center, Los Angeles, CA, USA;
2
Department of Surgery and Medicine,
University of Cincinnati Medical Center,
Cincinnati, OH, USA
Abstract: Laser Vision Correction (LVC) is an elective, self-pay and safe surgical procedure to
correct myopia and hyperopia. Since FDA approval 25 years ago, there have been a progression
of technological improvements leading to better outcomes and LVC is now one of the safest
surgical procedures. With a potential pool of 50 million patients, 6000 trained ophthalmic
surgeons regularly treating in over 1000 centers of which 65% are physician owned.
Treatments remain low from an earlier peak of 1.4 million to less than 800,000 over last 10
years. The factors preventing patients undergoing surgery have not changed and include the cost
of $2000 ± $1000 per eye and fear of laser surgery on their eyes. The latter is overcome by word
of mouth referrals and positive social media messaging. In addition, press misinformation and
lack of optometrists participating in co-management have not helped grow LVC procedures
despite the positive results of the FDAs Patient Reported Outcomes with LASIK studies known
as PROWL. The surgery is quick, and patients can be “in and out” in less than two hours with
a rapid recovery, minimal postoperative restrictions and within 24 hours have 20/20 vision.
Volume and price drives center and physician protability with a scheduling capacity of two to
four patients’ treatments per hour. Laser vision correction and especially LASIK, remains the
treatment of choice for myopic and hyperopic patients wanting to remove their dependency on
glasses and contact lenses.
Keywords: LASIK, excimer, optical, contacts, glasses, Covid-19
Introduction
In the twenty-ve years since the US Food and Drug Administration (FDA)
approval for laser vision correction (LVC) to treat myopia and hyperopia with
astigmatism there has been a progression of technological improvements from
unilateral Photorefractive Keratectomy (PRK), to bilateral Laser-assisted in situ
keratomileusis (LASIK) with wavefront or topographical guided treatments.
1–10
The ap initially created by a mechanical microkeratome now uses
a femtosecond laser.
11–13
Excellent clinical results with minimal side effects leads to extremely satised
patients.
We estimate over the last twenty-ve years only 20–25 million eyes were treated
with less than 800,000 eyes being treated each year for the last ten years. The
penetration of potential patients for treatment remains low at 0.2% per annum.
14
Word of mouth referrals and social media reviews have diminished the fear
factor, but cost remains an issue. The laser vision correction and particularly
LASIK remains the treatment of choice for myopic and hyperopic patients wanting
to remove their dependency on glasses and contact lenses.
6–10
Correspondence: Stephen N Joffe
Joffe Foundation, 4400 Drake Road,
Cincinnati, OH, USA
Tel +1 513 271 0670
Fax +1 513 271 8426
Email stephen@sjoffe.com
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http://doi.org/10.2147/OPTH.S299752
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Open Access Full Text Article
The manuscript is a personal perspective exploring the
potential market size for refractive surgery, ophthalmolo-
gists trained and performing the procedure, location of
lasers for treatment, pricing of treatment, economic impact
on a surgeon’s practice, clinical outcomes, and effect of
Covid-19 and teleophthalmology in the USA but can also
relate to the European market.
Materials and Methods
Literature searches were conducted in multiple databases
including Medline, PubMed, Scopus, Cochrane, Google
Search Engine and other internet and manual reviews of
citations and related articles. Other sources included indus-
try publications, paid subscriptions to research sources,
interviewing ophthalmologists, optometrists, and manage-
ment in the refractive industry, personnel at vision centers
and a personal perspective with involvement in various
capacities and in the laser vision correction industry.
In addition, SEC lings including industry quarter,
annual nancial reports from Companies afliated with
ophthalmology, optometry, medical devices, vision and
refractive surgery have been reviewed.
The material presented includes the refractive market,
ophthalmologists, procedures performed, pricing, clinical
outcomes, and effect of Covid-19 pandemic in the USA.
Results and Discussion
The Refractive Market
It is estimated that 75% of adult Americans or over
230 million people have some vision problem requiring
correction. Eyeglasses are worn by 50% of the population
and up to 14% or 46 million individuals wear contact
lenses. Some individuals wear contacts for social occa-
sions and glasses at work.
Myopia (Nearsightedness) is the most common refrac-
tive disorder occurring in 28% of the USA population and
an additional 15% are hyperopic with or without presbyo-
pia. The cause of myopia is unknown, but incidence varies
with age, gender, geography, race, genetic lines, education,
early reading, time spent outdoors and computer activities.
Myopia is found more frequently in younger white females
with graduate education and higher socio-economic status.
Up to 80% of Chinese children are myopic and references
are made to an “epidemic” occurring.
The 45 million (14%) myopic patients who wear con-
tact lenses tend toward soft and disposable lenses. Myopia
accounts for over 80% of LVC procedures.
14
The second category for LVC is hyperopia
(Farsightedness) which is found cumulatively in 15% of
an older adult population. Nearly all patients undergoing
LVC have astigmatism which is corrected simultaneously.
Figure 1 shows the various categories of vision disorders
and the percentage of patients with these issues as adapted
from the MarketScope Report.
14
(See Figure 1)
As shown in Figure 2, adapted from the MarketScope
Report, glasses and contact lenses are the treatment of
choice with a very low (0.2%) penetration for LVC.
15
(see Figure 2)
The vision correction market generated in professional
service fees of over $5 billion in 2016 and by 2019 it
increased to $6.3 billion mainly provided by independent
eye care providers. Sale of contact lens is approximately
$4 Billion; eyeglass frames $6 Billion and prescription
lenses have sales of $9 Billion per annum in USA.
The revenue from cataract surgery, which is the most
common surgical procedure, is estimated at $11 Billion
with 3.7 million procedures performed in 2020 by 9000
ophthalmic surgeons in USA.
16
This is in contrast to less than 800,000 laser refractive
procedures being performed by approximately 3000
ophthalmic surgeons with an estimated revenue of $1.5
Billion in 2020.
15
Other ophthalmic surgical procedures include the use
of retinal photocoagulation, vitrectomies and glaucoma
treatments with lasers, lters, and shunts.
Figure 1 Vision disorders in USA. This gure demonstrates in a pie chart the
percentage of patients with normal vision (30%), myopic (28%), hyperopic (15%) and
presbyopic (26%).
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The population of suitable candidates for LVC in years
2020–2021 is 150 million myopic and 50 million hyperopic
patients.
If consideration is taken relating to age, severity of
refraction, FDA approvals and affordability, of the
200 million potential candidates we estimate that the num-
ber decreases by 75% to 50 million as being the potential
patient pool. This pool annually grows faster than patients
being treated due to annual birth rates.
The two main factors causing patients to delay or not to
have LVC over the last 25 years remains fear and cost or
affordability. More recently professional misinformation
from optometrists and adverse media articles have also
caused patients to hesitate to have LVC.
17–19
In 1995 following much anticipation and excitement,
the Excimer laser was approved for refractive surgery by
the FDA. Initially, the Summit Technology Inc., Apex
excimer laser was approved on March 18, 1995 and on
September 29, 1995 the VISX excimer system manufac-
tured by AMO LLC was approved.
20
The expectations by ophthalmologists, optometrists, the
nancial community, and laser manufacturing companies in
the 1990’s was that there were ‘millions of patients’ waiting
to be treated with high expectation of a pent-up demand.
21
Within three years of FDA approval over 65 Companies
were registered in the USA to provide the LVC procedure in
newly established free-standing centers in the USA. These
Companies ranged from solo physician practices purchasing
or leasing the equipment, to facilities offering open access
similar to ambulatory surgery centers. Capital was raised
both privately and publicly with estimated projections of
billions of dollars in revenue annually.
Unfortunately, the projections never reached these opti-
mistic projections. There were multiple reasons for these
estimations being so wrong including patients fear of
lasers being used on their eyes, to the cost of the procedure
which was up to $3000 per eye.
Furthermore, many ophthalmologists were reluctant to
operate on a “normal” cornea with refractive errors. The
lack of referrals from optometrists wanting to maintain
their patients for annual eye examinations and continuing
to sell glasses and contact lenses also played a part.
The FDA approvals progressed through multiple stages
from photorefractive keratectomy (PRK) on a single eye
with minimal astigmatism correction, to bilateral PRK and
nally the less painful procedure of bilateral laser-assisted
in situ keratomileusis (LASIK) for myopia and hyperopia
including treating various forms of astigmatism.
1–13
Figure 2 Method of vision correction in USA. This gure demonstrates in a pie chart how vision is corrected on adults in the USA. Majority of adults wear glasses (50%),
contact lenses (14%) and very few undergo laser vision correction (0.2%) each year.
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A total of 72 FDA labelling approvals have occurred
for the laser manufacturers AMO, Carl Zeiss, VISX,
LaserSight, Nidek, and Bausch and Lomb since 1995.
22–24
Improvements in ap creation occurred as well with
replacement of the mechanical microkeratome and its
inherent ap risks to use of femtosecond laser for
a “bladeless” or laser/laser refractive surgery.
11–13
LASEK or Laser-Assisted Sub-Epithelial Keratectomy
has similar disadvantages as PRK but probably less pain
and more rapid healing but has obtained minimal penetra-
tion. Epi-LASIK is also infrequently performed.
25,26
Newer developments have led to wavefront-guided and
wavefront-optimized treatments that have minimized
induction of higher order aberrations after refractive
surgery.
27–31
Topography guided ablations have provided the ability
to treat irregular corneal topographic patterns and some
studies have shown they may achieve even better uncor-
rected vision with normal topographic patterns.
28
Other procedures began developing such as small inci-
sion lenticule extraction (SMILE) and phakic intraocular
procedures with lens implanted either in front or behind
the iris (IOLS).
32–37
Ophthalmologists and LVC
There are over 19,000 licensed and practicing ophthalmol-
ogists both Medical Doctors (MD) and Doctors of
Osteopathy (DO) in the USA. Over the last 25 years at
least 6000 or a third have undergone some form of LVC
training either in residency, fellowship or post-graduate
courses organized by the manufactures and professional
societies.
By 2020 nearly 4000 ophthalmologists were reported
being refractive surgeons giving a ratio of one surgeon per
90,000 population.
14
Further ndings show that 700 ophthalmologists per-
form nearly 80% of the LVC procedures. The majority
perform approximately 2000 to 2500 procedures per
annum with only approximately 100 to 200 surgeons
focusing their practice exclusively on LVC.
During the nancial crises, many ophthalmologists
stopped performing LVC and began focusing on building
a cataract or general ophthalmology practice.
As with all surgical procedures, there is a learning
curve and results would indicate more experienced sur-
geons focusing exclusively on high volume LVC practices
obtain best outcomes with the least number of unhappy
patients and less potential or actual litigation.
Centers Performing LVC
The majority of LVC are performed in a xed site facility
of which there are over 1000. These include approximately
65% being Surgeon-owned facilities, Corporate owned in
25% and less than 10% are hospital or military LVC
treating centers.
14,38
Currently there are no publicly traded companies per-
forming LVC. From the initial Corporate companies started
in the 1990s only several remain including LCA-Vision, Inc.
The latter investors in 2020 acquired the Laser Vision
Institute and TLC Vision centers from the Vision Group
Holdings (VGH) bankruptcy, NuVision is predominately in
California and the mobile laser company Sight Path offers
a mobile “roll on, roll off” service for both LVC and cataracts.
The J&J Visx and Alcon Wavelight account for over
90% of the installed base of over 1200 excimer lasers in
the USA.
14
Other companies manufacturing LVC lasers include
Bausch & Lomb, Nidek, Carl Zeiss, Schwind, LaserSight
and Summit Autonomous Laser, bought by Alcon which
was subsequently withdrawn from the market.
Procedures (LASIK) Performed
We estimate a total of 20 to 25 million laser vision correc-
tion procedures or 10 to 15 million patients were treated in
the past 25 years.
Figure 3 is the graphic representation of annual LVC
treatments performed over the last 25 years adapted from
various sources.
14,15
(See Figure 3)
LASIK will be the procedure of choice for many years
to come and accounts for 80% to 85% of the procedures,
PRK for 10–15% with the newer procedures such as
SMILE, corneal inlay and other intraocular and phakic
procedures are less than 5%.
To the consumer “LASIK” is the generic name for all
types of LVC surgeries.
From 1995 LVC procedures increased to 1.4 million
procedures by 2000 where it maintained this level for
several years and then declined related mainly to the
economy which it has closely tracked. In the last 10
years procedural volume has been relatively at ranging
from 600,000 to 800,000 treatments per annum.
Nearly 45% (340,000) of procedures are performed by
independent surgeons in their own ofces or in free-
standing surgery centers.
Corporate companies with less centers perform
a similar 45% (345,000) procedures in their facilities.
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The military including and other hospital-based institu-
tions account for under 10% (60,000) of the procedures.
38
Covid-19 and the elective surgical “shutdown” includ-
ing LVC caused a dramatic fall off in procedures in the 1
st
and 2
nd
quarters of 2020 but there has been a rebound at
the end of 2
nd
quarter, strong in 3rd quarter and in the 4th
quarter in certain geographical areas declined due to “lock-
downs” and increased fear of Covid-19 patients were
reluctant to have elective surgery. This indicates that pro-
cedural volume for 2020 year will be less than 2019.
Pricing of LVC
LVC is an elective surgical procedure and is rarely covered
by insurance and for the majority of patients it is a self-pay or
private pay procedure. Federal Savings Account (FSA) and
Medical Savings Accounts (MSA) can be used for payment.
The recommended fees and nal charge to a patient
varies tremendously by geographical market, physician
experience, name recognition, the refractive prescription,
type of excimer laser used such as traditional, custom
wavefront or wavefront guided, if punctal plugs were
inserted and if the ap is created by mechanical blade or
using a laser method.
Prices advertised to the consumer varies on various
websites and the price ultimately paid by the patient, the
Average Selling Price (ASP), maybe higher or lower
depending on the various factors listed above.
Some facilities charge a xed fee to include the pre-
operative examination, surgical procedure including drugs
and disposables and postoperative visits which can vary
from one to three visits or can be part of a “lifetime” plan.
Enhancements which have declined over the years, may
also be performed without cost for several years.
Discounts are often offered to entice patients to sche-
dule visits for preoperative evaluation and for subsequent
treatment.
Payments are made using cash (rare), credit cards
(often), checks and especially by signing up for nancing
offered by commercial banks and nancial institutions
such as CareCredit.
The websites of the various corporate providers such as
Laser Vision Institute (LVI), TLC Vision, LasikPlus and
NVision offer prices varying from $1000 to $4000 per eye
with promotions offering discounts either as a percentage or
a reduction of a xed dollar amount with an average ASP just
under $2000 per eye. Private practitioners charge an addi-
tional $500 to $1000 more per eye depending on experience
and geographical locations The MarketScope 2020 reports an
average price of $2632.00 per eye in USA.
14,15
Price is no indicator of quality or outcomes. Many corpo-
rate providers and high-volume surgeons have obtained
a large amount of clinical experience. Some low-cost private
providers may use older technologies with less preoperative
evaluations and shorter postoperative follow-ups.
Figure 3 Estimated laser vision correction (LASIK) procedures in USA 1996–2020. This gure is composed of multiple sources including personal experience and the
publications of both private and public companies of how many laser vison correction procedures are performed each year in the USA since FDA approval.
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Income for Ophthalmologists from LVC
The cumulative revenue for ophthalmologists performing
LVC is less than 5% compared to nearly 30% from catar-
act surgery due to the larger number of annual cataract
procedures.
Surgeons either stop performing LVC altogether and
change to other procedures eg, cataracts if income decreases
or perform both LVC and cataract surgeries, or exclusively
perform LVC. The LVC surgery is performed either in their
own private practice ofce(s) or by providing services to
Corporate practices on a part-time or full-time basis.
Table 1 shows an estimated nancial model of an LVC
Center. The variables inuencing protability are the aver-
age selling price, the number of treatments performed,
costs associated and efciencies in patient conversion.
The Table also illustrates the dramatic effect of doubling
the surgical volume from 42 to 83 eyes per month which
causes a seven times increase in gross prot.
Similarly, an increase in price by $400 per eye has 2 to
3 times increase in gross prot. (See Table 1)
As surgeons become more established the word of
mouth referral increases and the marketing costs can
begin to decline.
The LVC Centers have great surgical capacity advan-
tages. Fixed costs can stay the same with changes in
volume and only the variable cost increases or decreases
proportionately with volume changes.
Experiences and skilled surgeons performing LVC for
over 20 years are reporting cumulative treatment volumes
of 50,000 to 125,000.
The surgical procedure is relatively fast, and patients
can be “in and out” following an LVC treatment in less
than two hours. Surgeons should not be pushed to go to
fast and make mistakes.
Experienced surgeons treat up to four patients with
bilateral LASIK in an hour and if staff is efcient, the
centers can perform 60 to 80 treatments in a day. Certain
surgeons, require a 30-minute period for each surgery and
will not perform more than 10 to 20 treatments in a day
depending on surgical experience and use of either the
quicker microkeratome or slightly slower laser for creation
of the ap.
Outcomes and Patient Satisfaction After
LVC
LVC is an elective self-pay procedure with increased
expectations from the patient regarding outcomes.
Minimal requirements for LVC is freedom from glasses
and contacts but more realistically is the desire for the
equivalent or better vision often referred as 20/Happy.
39
Patients expect a “red carpet or ve star” professional
experience and near perfect vision outcomes without pain
or complications and a rapid recovery.
Multiple studies report outcomes from the initial FDA
studies to large randomized and meta-analysis studies that
show 99.5% of patients achieve 20/40 vision and 90% to
95% achieve 20/20 or better vision. The earlier complications
of ghosting, halos, glare, difculty with night vision do not
occur. In 40% of contact lens wearers, dry eyes is reported
which improves with LVC and intensive eyedrop regime.
39–49
Ectasia is now treatable and preventable with corneal
cross-linking and strict preoperative screening for subcli-
nical keratoconus with topography and tomography.
Neuropathic pain post-treatment is very rare.
50–57
Table 1 Impact of Volume and Average Selling Price on Gross Prots
Average Selling Price (ASP) $ 1850 $ 1850 $ 2250 $ 2250
Procedures per annum 500 1000 500 1000
Revenue $ 925,000 $ 1,850,000 $ 1,125,000 $ 2,250,000
Variable Costs ($350/eye) $ 175,000 $ 350,000 $ 175,000 $ 350,000
Contribution Margin $ 750,000 $ 1,500,000 $ 950,000 $ 1,900,000
Fixed Costs $ 500,000 $ 500,000 $ 500,000 $ 500,000
Marketing Costs ($300/eye) 150,000 300,000 150,000 300,000
Gross Prot $ 100,000 $ 700,000 $ 300,000 $ 1,100,000
Notes: This table shows the two possible selling prices per eye of laser vision correction (LVC). By deducting the variable and xed costs, a LVC center can have an annual
gross prot of $100,000 to over a $1 million. The two major variables are the average selling price and the annual surgical volume. Fixed costs do not change until there is
a much larger volume of cases. Variable costs include licensing fee, disposables, drops, blades. Fixed costs include rent, staff, depreciation (1,000 eyes per annum).
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Postoperative instructions for LASIK have become
more simplied with patients returning to most activities
within hours of surgery and by using a “common sense”
approach.
Litigation is the worst outcome of LVC. Fortunately,
LVC is one of the safest surgical procedures and many
practices incorporate proactive methods to prevent litiga-
tion. A 20/unhappy patient is a dissatised customer even
if the uncorrected vision is 20/20 or even 20/15.
The issue of needing reading glasses for presbyopia
remains an issue for patients due to the advertising mes-
sage of “freedom from glasses and contacts.” Similarly,
monovision or blended vision for older patients requires
education and pretreatment trials with only 50% of
patients being candidates for surgery.
Malpractice claims peaked in LVC in year 2000 and
with a steep decline since then. Ophthalmic Mutual
Insurance Company (OMIC), the insurer of nearly a third
of ophthalmologists stated that the majority of their claims
are settled are for less than $100,000. The PRK claims
occur less frequently but have greater payments.
58
Over the past decade since the great recession (2007–
2009) there has been a concerted effort by optometrists to
misinform patients not to get laser vision correction by
telling them astigmatism could not be treated, presbyopia
could not be helped and other reasons given to misinform
patients. Recently, half the phone calls to a Californian LVC
ofce were asking if astigmatism could be treated.
Furthermore, negative news stories brought on by the cam-
paign by Morris Waxler PhD, the former FDA advisor from
1996 to 2001 initially involved in the approval of Lasik was
now discrediting LASIK in the press resulting in a negative
impact on procedure numbers. Misinformation programs
are also one of the reasons for the lack of increase in laser
vision correction procedures.
To overcome negative press an assessment of post-
refractive symptoms was carried out by the FDA in colla-
boration with the National Eye Institute (NEI).
A questionnaire was developed for patients following
LASIK at the US Naval Medical Center in San Diego
with 262 participants and completed in 2014 was called
PROWL-1 an acronym for the Patient Reported Outcomes
with Lasik and an additional study in 312 civilian post-
operative patients was called PROWL-2.
In each of the PROWL studies, less than 1% of patients
experienced difculty performing their usual activities
following LASIK surgery due to any one symptom and
more than 95% were satised with their vision.
59–63
As so few patients experienced debilitating symptoms, the
FDA decided with its limited resources not to conduct a larger
clinical study to estimate prevalence of complications more
accurately or nd useful predictors in post-LASIK patients.
Patients besides assessing the risk versus benets of
LVC, should also include expected cost savings. The indirect
and direct expenditure is equal to 8 to 10 years of purchasing
glasses, contact lenses, solutions and eyecare visits.
64
Consideration of time to insert lenses and benets of
“lens free” occupations for reghters, police, healthcare
workers, safety for mothers and athletic benets for swim-
mers, runner and bikers.
Consolidation and Buyouts in
Ophthalmology
Private equity has been purchasing many ophthalmic pri-
vate practices often at premium prices. In the future, these
private practices will need to increase and nd alternative
sources of revenue. One area is enlarge the refractive
practices by advertising and increasing the optometric co-
management referrals. Mergers will continue and new
companies will enter the refractive market as the myopic
epidemic continues.
At end of 2019, there were 29 private equity rms
actively investing in ophthalmology. A total of 228 ophthal-
mic and optometric practices were purchased between 2012
and 2019 which included 1466 clinical locations.
65,66
Covid-19 Pandemic and Telemedicine in LVC
With forced closures for elective LVC centers due to
Covid-19 pandemic from late March 2020 to slow reopen-
ing in early June 2020, the practice of LVC changed.
67
Teleophthalmology consultation during center closure
went from minimal to nearly 80% with potential patients
scheduling surgery without an examination.
Patients appeared knowledgeable of their vision pre-
scriptions and had minimal questions besides asking about
potential dates for surgery, recovery time and if any
experience of pain. Cost appeared less of a problem with
money being available to pay for the procedure.
Factors motivating patients were glasses fogging up
with wearing masks, known as “glass fog”, increased
risk of wearing contact lenses due to facial hygiene with
less touching and patients physical facial appearance on
internet communication such as Zoom and Microsoft
Teams.
68
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As a result, similar to cataracts there is a pent-up
demand for LVC.
Following reopening of surgery centers in areas no
longer under lockdown, there has been an increase in
LVC and other procedures including facial aesthetic
surgeries.
69
Plotting the back log of LVC surgery post-covid using
the Monte Carlo stimulation applied to elective cataract
surgery study, we estimate an optimistic additional
300,000 LASIK surgeries in years 2021 to 2022.
16
LVC can be performed safely with Covid-19 precau-
tions including requesting all patients to wear masks,
restrict distances in waiting rooms, asking family and
friends to wait in cars outside, extensive cleaning proce-
dure rooms between each patient and using transparent
physical barriers where appropriate.
67
Despite all these new procedures, treatment efciencies
are being maintained after the initial learning curve. Pre-
operative and postoperative visits are by telemedicine if
possible, with minimal physical contact between LVC staff
and patients.
Conclusion
Laser vision correction (LVC) has now reached its 25th
anniversary since FDA approval in the USA. We estimate
20 to 25 million eyes have been treated giving a very low
0.2% penetration of treatments per annum for the refrac-
tive conditions of myopia, hyperopia with astigmatism.
The compounded annual growth rate for LVC is under
2% which is too low for a procedure which is safe, cost
effective and reliable.
Word of mouth from satised patients, co-
management, internet patient reviews and consumer mar-
keting are the main drivers for LVC treatments.
Cost and fear are still the major factors delaying treat-
ments. Fear has become less with the Covid-19 epidemic
due to masks fogging up glasses.
More telehealth consultations are needed with less
ofce visits pre- and postoperatively. Reduction in pricing
to make LVC more affordable will help considerably.
Surgical outcome results have improved dramatically
over the 25 years especially in high volume facilities
where processes have become standardized and best
practices instituted reducing errors by staff and
ophthalmologist.
To increase the current low penetration of refractive
surgery, word of mouth referrals and social media reviews
from past patients’ needs to spread the message of the
availability of a relatively painless procedure at an afford-
able price being available to correct an incapacitating
refractive error. Treated patients will not need to wear
their glasses or contact lenses for their nancially and
professionally productive years until they become pres-
byopic with advancing years.
Acknowledgments
I would like to thank Lisa Blaker of Joffe Foundation,
Cincinnati, Ohio, USA, for medical writing assistance
and preparation of the manuscript and Lewis Groden,
MD, Dean Ellis, MD and Lou Probst, MD Medical
Directors of LasikPlus Vision Centers, and LCA-Vision,
Inc., Cincinnati, Ohio for clarication of LVC treatments.
Disclosure
The author reports no conict of interest in this work.
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Актуальність. Для корекції аметропій використовують методи рефракційної хірургії, з яких Laser In Situ Keratomileusis (LASIK) у 80%–85% – процедура вибору. Синдром сухого ока (ССО) – найчастіше ускладнення LASIK, частота якого сягає 20% через 6 місяців після втручання. Персистуючий ССО після LASIK здатний викликати гіперплазію епітелію, що може бути пов’язана з міопічним рефракційним регресом.Мета: дослідити вплив персистуючого синдрому сухого ока після ексимерлазерної корекції міопії на віддалені функціональні результати.Матеріали й методи. Спостерігали за 65 пацієнтами (130 очей), яких поділили на 2 групи залежно від методу ексимерлазерної корекції (ЕЛК) – LASIK і FemtoLASIK. 40 людей (80 очей) – контрольна група. Пацієнтам перед операцією і протягом спостереження аналізували маніфестну рефракцію, кератотопографію, AS-ОСТ, сльозопродукцію, стабільність слізної плівки, профарбовування очної поверхні. Термін спостереження – 6 місяців.Результати. У пацієнтів з діагностованим ССО спостерігався міопічний регрес у межах 0,5±0,1 D. Його частота серед усіх пацієнтів – 10,7% через 6 місяців після ЕЛК. У них спостерігалося потовщення епітелію на 7,9±0,25 мкм у центральній ділянці, у зоні 5–7 мм потовщення епітелію було 2±0,3 мкм, посилювалася іррегулярність рогівки під час виміру іррегулярності рогівки (CIM – Corneal Irregularity Measurement) на кератотопограмі, що зросла до 3,01±0,12 мкм, і ступінь профарбовування поверхні ока підвищився з 0,22±0,08 до 2,3±0,08. Серед пацієнтів, які не мали ССО, не відмічали рефракційного регресу, профарбовування поверхні в термін 6 місяців після ЕЛК міопії, СІМ був у межах 0,49–1,68 мкм. Товщина епітелію в центрі перевищувала периферичну не більше ніж на 2,5±0,3 мкм. Маніфестна рефракція коливалася в межах +0,12±0,1 D. Висновки. Виявлено 10,7% серед усіх пацієнтів із персистуючим ССО після ЕЛК міопії, у яких зафіксували рефракційний регрес у межах 0,5±0,1 D. Потовщення епітелію в центрі рогівки після ЕЛК у пацієнтів без ССО менше на 37,5%, ніж у пацієнтів із персистуючим ССО. Товщина епітелію рогівки менша при міопії на 6,4%, ніж за відсутності аметропій. Кератотопографічні дані виявляють нерегулярний астигматизм при ССО, який знижує якість зору, і пов’язані зі змінами товщини епітелію, рефракційним регресом після ЕЛК міопії. Профарбовування поверхні рогівки – доказ пошкодження епітелію рогівки при персистуючому ССО після ЕЛК міопії.
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Small incision lenticule extraction (SMILE) is a new paradigm for refractive surgery, and was first performed by Sekundo and Blum in 2008. It uses only a femtosecond laser to carve out a lenticule within the corneal stroma, and then achieves refractive correction by extracting the lenticule through a small incision. A number of studies have shown that SMILE leads to stable and efficacious outcomes, combined with high safety. Long-term studies also indicate that SMILE has excellent outcomes combined with high safety. Although relatively safe, SMILE can have some intraoperative and postoperative complications, including suction loss during the procedure, lenticule tears, incision tears, epithelial ingrowth, diffuse lamellar keratitis, and residual refractive error. Studies indicate that SMILE leads to less postoperative dry eyes. It is thus preferred over laser-assisted in-situ keratomileusis (LASIK) in cases wherein there is mild dry eye preoperatively. It is also preferred over LASIK in cases wherein the patient is likely to engage in contact sports. LASIK may be preferred over SMILE for the treatment of hyperopia, and in cases of significant higher order wavefront aberrations or topographic irregularities.
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Purpose: Laser in situ keratomileusis (LASIK) and small-incision lenticule extraction (SMILE) are popular refractive surgeries. The objective refractive outcomes of LASIK and SMILE have been studied extensively; both procedures have comparable safety, efficacy, and predictability. However, owing to various psychosocial factors, refractive patients may report dissatisfaction despite good postoperative vision. Hence the importance of studies on subjective patient-reported outcomes. This review discusses the role of psychometric-technique-based validated questionnaires when evaluating subjective outcomes. It also summarizes the literature on patient-reported outcomes for LASIK and SMILE. Design: A literature search was performed on PubMed database to identify studies that have assessed patient-reported outcomes for LASIK and SMILE. Results: Several studies have looked into patient-reported outcome measures for LASIK, but the number of equivalent studies for SMILE is limited. Questionnaires (validated and non-validated) are used to evaluate patient-reported outcomes. Validated questionnaires are designed based on psychometric techniques, such as Classic Test Theory, Item Response Theory, and Rasch analysis. The Quality of Life Impact of Refractive Correction (QIRC) questionnaire, a validated questionnaire administered to both LASIK and SMILE patients, suggests that both groups have comparable vision-related quality of life in the first few months postoperatively; but SMILE might confer a slight advantage in the later postoperative period (postoperative month 6). Conclusions: Future LASIK-SMILE comparative studies utilizing standardized validated questionnaires for patient-reported outcome measures with longer follow-up durations would be a welcome contribution to this important aspect of refractive surgery.
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Post-LASIK dry eye is the most common postoperative dry eye after ophthalmic surgeries. The clinical signs of post-LASIK dry eye include positive vital staining of the ocular surface, decreased tear breakup time and Schirmer test values, reduced corneal sensitivity, and decreased functional visual acuity. The symptoms and signs usually last for about 1 month after LASIK. A small number of patients continue to experience symptoms more than 1 year postoperatively. It has been suggested that the loss of corneal innervation caused by flap-making is the major cause, affecting the corneal-lacrimal gland, corneal-blinking, and blinking-meibomian gland reflexes, resulting in decreased aqueous and lipid tear secretion and mucin expression. A new type of corneal refractive surgery, SMILE, which has less impact on corneal nerves, induces less postoperative dry eye, supporting the association between corneal denervation and postoperative dry eye. As LASIK enhancement by flap-lifting induces fewer dry eye symptoms and signs than initial surgery, factors other than neurotrophic effects may be involved in the mechanisms of post-LASIK dry eye. Post-LASIK ocular surface pain is a type of postoperative chronic pain and discomfort, and is thought to be a different clinical entity from dry eye, possibly induced by abnormal reinnervation or neural sensitization of peripheral nerves and the central nervous system after LASIK. Treatments include tear supplements, anti-inflammatory agents, meibomian gland dysfunction management, ointment and eye patches, punctal plugs, and autologous serum eye drops. For patients with preoperative dry eye, careful patient selection, and preoperative ocular surface management are mandatory.