Thank you very much. Welcome, everyone. It's our pleasure today to host our Investor and Analyst Day. This is our 2nd the last was in November of 2017. Our goal today is to give you a look at where we've come from, but more importantly, most of our time will really be spent on where we're headed and why.
And I'm very pleased to today welcome surgeons who are joining us to talk about their experience with the ICL, as well as to talk about the future direction of the ICL. So you'll be hearing from them and I will mention them during my presentation. So the future of refractive surgery is lens based. The time for STAR is now. Recently, I attended our experts meeting and the European Society of Cataract and Infractive Surgery meeting in Paris.
And while I was there, one of the most influential leaders in ophthalmology globally, Doctor. John Vukish, talked to me for the first time about his new venture. He is here in the United States. You can read about his background in the material in front of you. But Doctor.
Vukic has been responsible for over 16 clinical trials as a medical monitor. He is believed to be and has earned the designation as one of the top innovators in ophthalmology. And we invited him to be here with U. S. Surgeons to talk to you, but he was unable to attend and sent his regrets.
But he also sent the following paragraph, which I would like to read to you because I think it really does bode well for what we're talking about in terms of the future of refractive surgery being lens based. Intraocular refractive surgery is the next wave of growth in the eye care space and STAAR is the clear leader in this technology. The success that STAR has demonstrated in Asia is a leading indicator for what I expect to happen in the U. S. Market.
I am opening 2 new practices in Milwaukee and Minneapolis in January, and the ICL is a cornerstone of our business plan. I will not be offering LASIK and we'll have the 1st fully intraocular refractive surgery clinic in each location. We are on track to open 4 additional clinics in major metropolitan areas within the next 24 months. There are significant tailwinds that I believe will drive ICL growth. While the LASIK market has contracted, the desire to be free of glasses has not gone away and there is pent up demand that will fuel ICL growth.
The distinction between cataract and refractive surgery is blurring as all intraocular surgeries now have a refractive endpoint with the expectation of clear, spectacle free vision. The ICL is a natural fit for anterior segment surgeons who offer premium IOL options. The future looks bright for the ICL in the U. S. And I anticipate accelerated growth as the EVO models become available.
So, we believe as we've seen in China, Germany, Japan, other markets in Europe and now it's beginning in the U. S, intraocular based surgery clinics. So, we're going to be talking about this large and growing addressable market. Our proprietary lens technology and business model, which is driving industry leading growth and our strong financial performance, including expanding margins and cash generation. So the total available market as we see it really includes now for STAR both myopia and presbyopia.
And you're looking at 1,900,000,000 myopes globally and 1,700,000,000 presbyopes. Today, refractive surgery really encompasses about 4,000,000 eye procedures, but the opportunity is far greater. The way we see it, there are 35,000,000 MYOPS who really pass all of the criteria in terms of interest, age, ability to pay, demographics and even more in presbyopia. We believe there are over 55,000,000 presbyopes. So, STAR has a huge opportunity with this wave to lens based technology being in the leading position we enjoy.
So we also believe, unfortunately, that myopia will continue to progress and is becoming more and more worrisome around the world. So that as you can see there in a chart by 2,050, the expectation is there will be over 5,000,000,000 MYOPS globally. And so the need to be able to provide excellent technology, curb the progression of the disease and help those to have visual freedom will become a greater and greater need over time. And 75% to 80% of 45 to 54 year olds are using some correction today for presbyopia. So the numbers are truly astounding.
And the number of individuals who tell us they do anything to get rid of their reading glasses continues to get greater and greater. And every year today for vision correction, over $70,000,000,000 is being spent. You can see it in eyeglasses, contact lenses and refractive is a small portion of that. It's our goal and intention to switch those numbers around for refractive surgery to be a leader or at least the intermediate choice. Our lens based technology as you are all aware is colimer.
Colimer is extraordinary. Colimer performs exceptionally well. You'll hear about that from Doctor. Mark Packer today. He follows me as he talks about the clinical evidence that supports the paradigm change to lens based technology being the primary focus in refractive surgery.
99.4% of patients would elect STAR's EVO implantable, columnar lens again. This is an extraordinary and exciting capability in terms of individual support and individuals on social media who talk so excitedly about our technology. And the reason why is because ICL advantages are exceptional. The lens is removable, eco friendly, biocompatible, no dry eye syndrome, upgradable, there's no capital investment, it's additive, provides excellent night vision, UV protection and is quiet in the eye. And the proprietary color material helps give us this extraordinary capability and the quality of vision is exceptional.
So industry leading growth, what's been happening? Since 2016, we have been growing very, very well. And since 2017 to what we project through 2019, we a 22% compound average growth rate. And you can see here how nicely this performance is benefiting STAAR when you look at the ICL unit growth being the real engine. Through 9 months of the year, you can see that Japan is up 54%, China 50%, Korea 49%, and a total of 35% globally.
But we thought we'd add a few markets you're probably unaware that we participate in rather aggressively. So, we've been up in the UAE by 30%, Malaysia 29%, Italy 27% and down the list. But all over the world, we have representation and we have interest and we're growing. So how are we growing? We're growing very well and very profitably.
Our gross margin has gone from 68.4% in 2015 to 74 0.7% year to date 2019. We told you that when we were transforming the business from 2015 through 2017 that it would be at an expense that would require us to have negative operating margin. But we also said that when we were finished with that big rebuild that we would begin to generate cash and have positive operating margin and we would be able to sustain it, which we have. So we've now moved from a negative 7% to a positive 8.5% year to date. And our GAAP earnings per share has gone from negative $0.17 up to positive $0.16 while we have been growing and changing this business.
The cash from operations has moved from negative burn to positive cash generation of $16,000,000 year to date this year. And on the balance sheet, we're happy to say that we have 112 $300,000 $78,000,000 of which we raised a few years ago. Our global eye print, as we like to call it, continues to expand. The way that we'll approach these markets will begin to move more closely to hybrid to direct over time. Today, our direct markets are the United States, Canada, the U.
K, Germany, Spain and Japan. Our hybrid markets are China, South Korea and India. This is where we have star personnel that do the majority of the work around clinical, training, practice development, as well as selling and marketing. Potential future hybrid markets include Western Europe and other major countries around the world. Our ICL global market share has gone from less than 2% to 6% we estimate to date in 2019.
Our largest shares are in Japan at 23%, China at 14% and South Korea at 12%. In China, we're often asked, what's going on? Well, we've captured 14% market share, and we've seen the peak summer season with thousands of ICLs implanted daily. You can see here on the left the hospital waiting room and the right, there's a picture from WeChat posting of EVO patients excited and ready for surgery. We've also been doing a lot of with our partners in China, consumer marketing propelling our EVO growth.
We also have told you about EVO only clinics opening. Well, this has moved from a single clinic in a high profile Shanghai shopping center to a commitment to dozens of these clinics opening over the next few years. So the paradigm change here is not only that we're moving from laser based to lens based, but that people are actually walking in during a shopping experience to learn more about this technology and choosing to have a procedure. While we were at our experts meeting, there were a number of excellent presentations. And many of you ask and rightly so, how can we get access to some of this information or to some of these individuals?
So with their permission, I'm going to play a short segment of what was presented at our experts meeting. And first, we'll be hearing from Doctor. Zheng Wang from China.
Some of you, think, probably have already known that the IRi Hospital Group is a huge hospital chain, which has over 400 hospitals worldwide and over 30,000 employees globally, including 3,000 and 600 doctors. In the past few years, the volume of iCL has been growing tremendously, which is much faster than that of the laser vision corrections. And as of last year, iCELL was performed in 145 hospitals by 100 surgeons in the IR group. Yes, there are more ICL centers than number of ICL surgeons in the group. In other words, some surgeons are practicing doing ICL surgeries in multiple hospitals.
So the demand for ICL surgeons is very, very high. The training of the trainers is the critical part of standardization. So we have trainers, trainers' trainers courses and all the trainers have to go through this test, this process, which has test for relevant knowledge and surgical skills too. This year alone, over 100 doctors have been trained in these 5 centers for ICL surgeries.
Next, we'll talk about what's going on in Japan. With surgeon support and consumer marketing, celebrity driven awareness and evil ICL only clinics, Japan has really embraced the ICL. As you know, the Japanese Ophthalmological Society has approved going down the diopter range to minus 3. We have had the benefit, which David Kromansky, our Head of Consumer Marketing will talk about more definitively during his presentation in terms of getting excellent uptake from influencers and celebrities in Japan, we definitely will be part of the consumer experience at the Tokyo 2020 Olympics. Now we'll hear from Doctor.
Yoshihiro Kidezawa.
First, I'll explain why I moved to an IONIQ practice. And after that, I will explain early clinical results of the EVO and the plus VISION cell future KA cell cohort in an isogenic practice. This graph shows the degree of myopia of ICEL patient at my previous Quebec and I clinic. In 2008, most of the patients were in high to extreme high myopia range. But recently, low end myopia patient increased, and the average dropped to -6.81 diopters in 2018.
There are some reasons why the number of iCell surgery increased in Japan. The first one is iCell has become recognized by Japanese ophthalmologist. This graph shows the survey during the past 10 years among JHL members. The percentage of doctors offering RACE has decreased, while those offering ICL has increased. We have currently over 200 clinics offering ICEL in Japan.
In the next graph, you can see that ICEL has replaced LASIK as the most used reflective option in the future. JCL's members were also asked what the defect options they would choose for their own eyes. Again, the risk percentage has decreased, while eyes are increased. Based on the increasing recognition among Japanese surgeons, they now offer iCell to even more patients in low diopters. JAPA iCell Study Group performed a mild center study to compare low to mild with high myopia patient, which was published in BZERO in 2018.
Based on this study, JACR submit a request to JOS. And in 2019, JOS modified the refractive surgery guideline starting from minus 3 diopters instead of minus 6 diopters. Based on the safety of EVO vision AI cell, recognition among Japanese surgeons and the patient awareness has increased. There are some reports of serious complications of race counterarchisms. And also, patients are now selecting the best brand.
It has enabled iCell to become a main diffractive option. Take home message. Based on the safety and the efficacy of the Evo and Evo vision ICL case like report, I expect that IC only practice will become a common institute to compensate for the laser refractive surgery centers.
And what's going on in Germany and Spain? Surgeons support and strategic partnerships have been growing very, very well. We announced recently strategic partnerships with Vista's 49i Clinics, which covers Spain, France, Portugal and Morocco Smile Eyes Group, 13 eye clinics in Germany and Austria and a global partnership model we're using now with single surgeons very effectively with Doctor. Neu Han. So what we wanted to do is bring you from Germany, the opinion.
And just so you know, all of these presentations that you're getting a bit of a vignette from, these are independent, of course, of STAAR. And these individuals create their own presentations in topics that we find important. And the majority this shared experts was talking about the growth of the ICL and how critical it was to their
refractive procedure numbers from the last And here are refractive procedure numbers from the last 5 years. And you see the gray bars, which are our laser volumes. Light blue is clear lens exchange and deep blue is ICL. And in the 1st year, it was only a couple of cases of ICL surgery. But as you can see here, the Deep Blue bar is increasing and increasing.
So if we look in another way, the blue line is the percentage of ICL surgery in our centers. We started with about 3% in 2014, and now we are in between 20% to 25% of our cases for ICL surgery. So ICL is the fastest growing procedure in our clinic, and the annual growth rate of our laser surgeries out over the last 5 years is 8%, and for ICL, it's 88%. So this somehow shows the dynamic of the process. And if you compare it to the average German market, it's only 5 percent it's only 4%, sorry.
Why is that so? Of course, it's because of the excellent results. We all know that accuracy, stability, efficacy, everything is just great from my personal point of view with ICL. But in the end, this gives a very high patient satisfaction. That's what we want.
That's what we need. We've got a high patient satisfaction. Surgeons also are very satisfied. And last but not least, it's about the safety. Why is the ICL growing?
Because we widened our range for indications for ICL. We do it in high yarrow myopic cases. Now we slipped from minus 8 to minus 7, so we are coming down and down. Of course, suspicious cornea or whenever there are any red flags for laser vision correction. So with the cooperation with STAR, ICL is the fastest clinic, we want to increase the awareness of the procedure even more.
Last but not least, we want to do this because we are waiting for future things to come. We are waiting for the EDOF ICL. And we hope, we think, we believe that this will be a game changer, and we want to be prepared for that.
Okay. So what's going on in the United States? We have 3 surgeons with us today who will give you their perspective on what's going on in the future. I already referred to Doctor. Vukic's plans.
But what's really critical here is bringing this successful business model to the U. S. Now. We know that EVO is coming, but we're also very confident that this business model works. Our Chief Medical Officer, Doctor.
Scott Barnes, has been working very successfully with surgeons throughout the U. S, some of whom were helped greatly around demystifying doing peripheral iridotomies, making sure that they were properly trained and not afraid to really aggressively tackle that procedure to get more and more ICLs today and not wait. Our clinical trial is imminent and our Head of Clinical Affairs, Doctor. John Hayashida will give you an update on that later. We did talk about having our inaugural U.
S. Surgeons Summit. It was very of recently signed strategic alignment agreements all throughout North America. What else is going on in the United States is that we're starting more outreach. And what you can see here is an ad feeling trapped by your glasses, which you'll hear about more later.
But this is actually in St. Louis. You can see a billboard that carries this ad. And what we found is during the campaign, as a result of it, we had a 200% increase in Doc Finder visits to the website. So there was some real interest and we believe that the kind of marketing, talk about later.
So STARZ execution, very briefly, 3 we gave you a 3 year financial outlook on Investor Day a few years ago. We're happy to say that the promises we made are promises that we have kept. Our annual revenue growth of 15% to 20% promise has actually resulted in 20% to 30 7% annual revenue growth. Our stretch target of +25 percent ICL unit growth has culminated in 36% to 54 percent annual ICL unit growth. Our profitability improvement to achieving sustainable profitability positive EPS, By the end of the 3 years, we actually accomplished all of this by the way within 2 years.
So that's why we're introducing today in a moment the next 3 year outlook. But we from GAAP EPS, as I said earlier, are now in positive territory and plan to sustain it, maintaining improving cash flow. And we said we would achieve $25,000,000 of total cash. And as I said, we're well over that and expect to continue this excellent performance. So what's our vision going forward?
What are we going to focus on in 2020, 2021 and 2022? Well, the goal here is really to take what we now know is real in terms of what this lens can do, how critical it really is to excellent performance in surgeons' hands and patients' desirability and patient satisfaction. So now we're going to position this EVO lens as special and transformational pathway to visual freedom. We're going to do this by promoting We're going to support the transformation of the refractive surgery paradigm to lens based technology through clinical validation and medical affairs excellence. And you'll hear from Doctor.
Packer in just a moment how this is already transcending to the kind of excellence in terms of making this claim work. We're going to innovate and develop a pipeline of next generation premium columnar based intraocular lenses, monofocal presbyopic and accommodating. And you'll hear later from Doctor. Keith Holliday about our progress in that regard. We are going to get gross margins above 80% for the entire business, continue our strong commitment to a culture of quality and hopefully continue to delight shareholders.
So what is the financial outlook? Revenue growth, we're looking at 25% compound average growth rate by year end 2022. We will talk about how this plays out in 2020 at the JPMorgan Conference, which is our custom. Our ICL unit growth, we're looking at 35% compound average growth rate by year end 2022. And you can expect just as we have already accomplished that we will do more and better as time goes on.
In 2021 and 2022 in those years, we fully expect presbyopia lenses as well as EVO in the U. S. To materialize. We will continue with profitability improvement by prudently investing in consumer awareness, commercialization and clinical studies required to get our new lenses approved. We will continue with strong cash flow and our balance sheet cash increases.
From a revenue perspective, where are we going to focus? EDOF presbyopia ICL on the market, we believe in the Q2 2020 followed by a phased rollout that U. S. Growth will accelerate preparing key cities for future EVO launch. We'll keep building China aiming for 25% plus procedure share.
We'll continue the modest trade offs of price for volume to get more mid low diopter range lens. We'll increase our consumer outreach efforts in key markets. And we will invest as I said in hybrid distribution models to increase our growth profiles in critical markets. We're targeting a total of $4,500,000 of manufacturing costs over the planning period. We expect our operating expenses as a percent of revenue will go down by the end of the 3 year cycle.
We expect our R and D spend will settle into the mid teens. Our capital and operating investments will include improvement and expansion of advanced engineering and technology in Monrovia, the opening of NIDA in Switzerland for China and European markets and Lake Forest being our highest level production facility for the manufacture of presbyopia EDOF lenses. We will focus on clinicals in the U. S. And EDOF presbyopia Vopia clinicals for the rest of the world.
We'll continue our commercial build out, digital marketing investment, surgeon support and patient outreach. So we truly believe the future of refractive surgery is lens based and the time for STAR is now. Thank you very much.
Thank you, Karen. I'd like to invite Doctor. Mark Packer to present.
Thank you.
Thanks so much. It's wonderful to be here and see all of you this morning on this chilly day in New York City. So my experience with the ICL incredibly to me now began 20 years ago when I was in clinical practice in Eugene, Oregon and my senior partner was a principal investigator I was a sub investigator in the MICL trial. So I got to see these patients who were enrolled in the trial right after they had surgery. And they were the happiest patients I had ever seen in my youthful age at that time, but they remained the happiest patients I had ever seen throughout my career.
And when the ICL was approved and on the market, I became one of the more enthusiastic implanters of the ICL. We absolutely loved it in our clinical practice, I've been working with STAR to look at the global experience with the ICL and EVO as it is today and this has resulted in 2 important publications. 1, the meta analysis and review on the safety and effectiveness of the ICL and the other, the review of EVO with the central port design. And I'll review some of those findings with you today. These are just a few slides here from a presentation I gave in Hawaii 10 years ago, almost 10 years ago when I began doing same day bilateral ICL.
Now this was already the custom with laser refractive surgery. Everyone was doing both eyes on the same day with LASIK. But it was a new idea that you could do intraocular surgery like this but patients loved it and the safety was there to support it. There was no reason not to go ahead and do the fellow eye right after fellow eye right after doing the first eye on the same day. And this was the biggest wow that I had ever experienced as a surgeon when a patient would sit up after surgery and say, Oh my God.
And you'd say, What? Can you see the clock on the wall? He's like, No, I can see the wall. I mean, these people were functionally blind. And they were the kind of people who if they woke up in the middle of the night and there was an emergency, they would not be able to find the door.
So this was life changing for these people. And that's what inspired me to be so enthusiastic about the ICL. And it's not just me. These are just a couple of quotes from other surgeons that have been published optically superb correction of relatively high degrees of amotropia which is another way of saying refractive error seeing well right off the table they get up and immediately have perfect vision. And these types of results are reflected in the literature in general.
So here you can see an efficacy index. What's an efficacy index? Okay. That is the ratio of how well people see after surgery without glasses compared to how they saw before surgery with glasses or contact lenses. So an efficacy index of 1 means perfection.
That means you see just as well after surgery with nothing as you did before with whatever you had. But look at this efficacy index. It's greater than 1 with the ICL up to 1.3rd. I mean, amazing, right? And accuracy to target almost 99% within a diopter of target.
And long term it doesn't change this graph on the right shows after 5 years virtually no change So excellent results that remain stable in the long term. This is what the literature shows. As Karen mentioned, almost 100%, I mean, 99.4% say they do it again. I mean, that's remarkable. Usually, we see we're lucky in ophthalmology that we have such great procedures.
Cataract surgery is remarkable, right? And generally, when you ask people, the satisfaction rates never get above 95%. For cataract surgery, which is the most successful and widely performed surgical operation in the world today, but with the ICL, it's above 99%. It's truly remarkable. And these results are also reflected in tangible improvements in quality of life.
So this is what research shows that this really improves people's lives. And that's the underlying reason why STAR is so successful today because people love this procedure and how it revolutionizes their daily living that's really what this is all about So why is it then that we are still looking at sort of this traditional paradigm of refractive surgery where laser surgery, corneal refractive surgery, LASIK, is still the treatment of choice for low to moderate myopia. It's because it's been considered less invasive than intraocular surgery than putting a lens in the eye. And so lens surgery has been restricted to higher myopia because it's been perceived that the complications Ophthalmology. Kerito refractive surgery, LASIK, can be applied across a broad range of refractive errors.
But in some circumstances, the surgeon may consider an intraocular procedure. So this is the traditional paradigm of refractive surgery. Stay on the outside of the eye because it's safer. But if you can't do that, then well, okay, I guess you can put a lens in. That's been changing.
Here you see the cover of cataract and refractive surgery today from a year or so ago is lens surgery, the new LASIK. And here's the article I contributed to that issue, why you should consider adopting phakic IOLs. So clearly, there's some movement here and I think the numbers Karen presented definitely show that there is some movement because EVO is disrupting the traditional paradigm. Now how is that happening? Remember that the whole reason for the traditional paradigm was about safety, right?
But EVO has shown improved safety over earlier models of fakig lenses. In fact, evovisian ICL safety and effectiveness today are comparable to those of LASIK and SMiLE, all types of laser refractive surgery. And I'll show you those numbers in just a minute. And importantly, EVO demonstrates the same excellent results in low to moderate myopia, which has been restricted to laser surgery in the traditional paradigm. So this is one of those papers I mentioned that was published recently, the review of EVO in the literature.
And I'm going to show you some of the important data that are in that paper. So if you look at the global literature, all of the scientific publications that have been published in peer reviewed journals around the world regarding EVO, there's over 4,000 eyes that have been treated with follow-up to 5 years. Now the safety index, you remember I mentioned the efficacy index. That's how well you see without glasses. The safety index is how well you see with glasses after surgery compared to how well you saw with glasses before surgery.
So it's a measure of safety. It's asking, did you lose anything by having this procedure? And again, 1.0 would be perfection means you're exactly the same after as you were before. But in fact, it's 15% better than perfection. So it's extremely safe.
And if you look at the important types of complications that have been a concern traditionally that have restricted fake lenses in that traditional paradigm cataract 0% out of over 4,000 eyes with 5 years of follow-up. Elevated intraocular pressure, pupillary block, one case out of 4,000. No other types of glaucoma have been reported with this lens. It's extraordinarily safe. What about SMiLE and LASIK.
Now you can see, 1st of all, the baseline there in that first column shows that in general, EVO is treating a little bit higher on average, but a much wider range of refractive errors, right? 2nd column is that efficacy index I mentioned. Again, 1.0 would be perfection. Anything above 1 is better than perfection and you can see EVO is 1.04, the best efficacy index of the group with SMiLE and LASIK following. What about accuracy to target?
What you want to see there ideally in a perfect world would be 100%. Nobody can achieve that today with anything. But you can see that EVO is right in there with over 90%, very comparable to LASIK also just over 90%. And if you look at the next two columns at astigmatism correction which is of very significant importance because there's so much astigmatism with myopia you can see that EVO really outperforms the other procedures. Visual acuities here you look at the mean visual acuity 0.0 is perfect again that means you're 2020 Negative numbers are better than perfect.
And you can see again that EVO is slightly better than perfect, very similar to the other results, right? How many are 2020 or better? 97% with EVO compared to just under 90% with Smile and just about 90% with LASIK. So the effectiveness is very, very similar across the entire range of refractive error and the safety is outstanding. This is why EVO is disrupting the traditional the referred to in the video you saw from the experts meeting in Japan with 351 eyes and you can see that in that lower left graph on the bottom left are the ones in the low to mild myopia range.
And then the grayer dots are the higher my but the results are identical for low to moderate or high myopia. It stands to reason. The correction is the same. The lens is the same. The only thing that was keeping people from using it to treat low to moderate myopia was safety.
But EVO has addressed those safety issues. That's why it's disrupting the paradigm. And satisfaction, that amazing 99.4% you saw is actually the highest of the 3 types of surgeries, LASIK and SMILI, as I mentioned. Also, we're very lucky in ophthalmology. People are so happy with what we do, but you can see they're happiest with EVO.
So EVO is disrupting the refractive surgery paradigm because primarily it answers the historical safety concerns, which were really never an issue for EVO. They are hangovers from older models of fake refractive We've seen that it demonstrates effectiveness across a broad range of refractive error. The safety and effectiveness outcomes are comparable to those of corneal refractive surgery. And there's an additional benefit because there is no alteration to the eye. The eye is the same before and after.
You haven't changed the cornea. You haven't removed the crystalline lens. So future upgrades or other procedures remain an option. Now don't just take my word for it. How do we know that EVO is disrupting the literature, scientific literature published comparing EVO to corneal refractive surgery, randomizing patients to 1 or the other.
That's a clear sign that the authors of these papers consider them to be equivalent. Number 2, positioning of EVO in clinical practice. And you've already heard today that there are now ICL only clinics, something that 10 years ago no one would have dreamt possible. And finally, we have now seen the emergence of competitors in this space. And you know imitation is the sincerest form of flattery.
So if other companies want to get in on this, it shows we've got something good. So here, first, is an example from the literature. In this study, patients were randomly assigned to an evotoric lens to femtosecond LASIK or ReLEX SMIL. 30 eyes of 30 patients in each group 20 to 40 years of age, low to moderate myopia minus 3 to minus 8 with some amount of significant astigmatism and 1 year of follow-up. And what did we find?
Well, all three groups were comparable in terms of the basic effectiveness for uncorrected vision. They all did well. But EVO had the highest efficacy index, the highest safety index. There was no change in the cornea. There was no dry eye.
Contrast sensitivity was significantly better with EVO than with the corneal refractive procedures. There was a significant improvement in aberrations with EVO, but not really with the corneal refractive procedures. And of course, patients reported excellent satisfaction with their vision. So what does this mean? Well, when you randomize people to these three procedures, the people who got EVO do a little bit better across this range of low to moderate myopia.
This is a slide that was presented by Jose Alfonso from Spain at the Experts Meeting showing how he places the Visian ICL in his clinical practice. And you can see it spans the range of refractive error from hyperopia to high my opia. There's a very small light blue box where he's still doing LASIK. Everybody else is getting an ICL. And in the older patients, the EDOF ICL in the future.
And then for older patients, when you start to get 60, 65 getting closer to the cataract age range, you're looking at refractive lens exchange. So removing a lens before there's a cataract and then placing a multifocal or monofocal type of lens. So basically for everyone under 55, it's EVO. And as I mentioned, you can also see this in the purely lens based refractive surgery practice. Here's an article published recently in Cataract and Refractive Surgery Today, Europe, talking about refractive surgery without a laser.
This is a huge benefit. And you mentioned Karen mentioned John Vukic and his new endeavor here in the U. S. With lens based only practices. If you're trying to set up a refractive surgery practice today and you need a laser that is a huge capital expense.
And when you look at the past 10 years of LASIK volume and you see that the curve is flat or slightly negative, about 500,000 cases a year in the U. S, there's no growth. You're thinking, well, why should I now spend $500,000 on a laser? I can do this without a laser with no capital expense. That's a great business model.
That's why we're seeing the opening of these clinics. Finally, there are some new kids on the block, new fakic lenses recently introduced outside the U. S, which look a whole lot like EVO posterior chamber, fakic lenses with a central port design. So it's been interesting to watch this development. These companies are basically competing on cost because they cannot compete with columnar, right?
That is sort of the secret sauce that STAAR has. And when you look down the long road of history of fakic lenses, how many have stood the test of time? Here's a little pictorial display of 16 different Fakik lenses, which have been introduced over the years. There's only one of these that is still a viable lens on the market not just viable but hugely successful and that's the ICL, a 1000000 lenses implanted with over 20 years of experience. We recently saw one of the sort of last lenses standing sort of start to go down the tubes, the ARTISAN lens, which was an anterior chamber lens fixated to the iris, which was approved in the U.
S. A little after the ICL. I was involved with that clinical trial also. Never really loved that because it required a bigger incision. But 10 years later, it started to turn out these lenses were really damaging the cornea.
And it wasn't such a good idea. So it took 10 years to learn that. Things can happen, but we've got 20 years of experience with the ICL. I've got patients today that I put those lenses in 20 years ago and they're still doing extremely well and very, very happy. And it's because the lens is unique in its forgiveness.
It's so soft. It's so pliable. It's so gentle in the eye. And that's polymer. The material really does matter.
So the new paradigm is finally emerging, this incredible momentum in the global market that you just saw presented outstanding effectiveness 1,000,000 implants and more than 20 years and moderate myopia with over a 1000000 implants and more than 20 years experience. It's incredible. And now the future is here with 2 new applications and designs for this lens, the supplemental lens which is also known as a piggyback lens and the EDOF ICL for presbyopia. Now what is a piggyback lens? So this is a lens for people who've already had cataract surgery, but maybe the refractive target was missed, maybe because they had LASIK, right?
So if you had LASIK, it becomes much more difficult to accurately target the refractive outcome of your cataract surgery. Even now, still today, we don't have a great way of understanding the refractive power of the cornea after it has been altered by laser refractive surgery. So here's a patient coming in who had LASIK 10 years ago, let's say, now has cataracts. They paid money 10 years ago because they wanted perfect vision. And now you have to tell them, you know what, because you wanted perfect vision and paid for it, I can't guarantee it to you now.
It's iffy. We'll do our best, but you may need a second procedure. What would that be, doctor? Well, we don't really want to go do more LASIK on your cornea, but what we can do is put in a supplemental lens, a piggyback lens that sits over on top of the lens we'll put in when we remove your cataract. Now in the U.
S. Today, there are no lenses approved specifically for purpose, but outside the U. S. There are several approved. And the ICL has been used already off label outside the U.
S. As a piggyback lens for pseudophakic enhancement of postoperative refractive error. It clearly works. There's no reason why it wouldn't work. It's exactly the same thing as using it in a phakic eye except that there's no the lens is a pseudo phakic lens now.
So what's the opportunity here? Well, almost 21% of patients with a history of LASIK are going to need an enhancement, 1 in 5. That's what I just said, right? If you're a LASIK patient, now you need cataract surgery, you come in and see me, I'm going to say you might need another procedure. What's the chance?
Well, it's about 1 in 5 you're going to need another procedure. But don't worry we have a solution and part of that solution can be the VIZION EVO ICL. But an even bigger opportunity exists in the correction of presbyopia. Everybody gets presbyopia. It's universal.
That's just the nature of the aging eye. In fact presbyopia just means old eye, right? That's what it means. And so that inability to see up close that starts to weigh people down in their 40s, they start to feel old, they can't read the menu in the restaurant. I mean, it's really disabling.
And what have been the solutions for that? Well, we don't have a perfect solution, perfect surgical solution. But now we've come a huge step closer with the EVO EDOF ICL. And what is EDOF means extended depth of focus. So it's not a multifocal where you have a near and afar.
It's more like a continuous range of focus more like the youthful eye. It's a more natural way of maintaining near vision. And importantly, it does not require removing the natural lens, right? Because the answer in many surgeons' hands to presbyopia has been to do a refractive lens exchange, take out the clear lens, put in a multifocal IOL. I've done a lot of those.
And it can be very successful. But you lose the residual accommodation in the natural lens and it's more invasive obviously removing the lens. So it's great if you can do this correct their refractive error correct their presbyopia and leave their eye completely intact. So that's the beauty of the EVO EDOF ICL. As you know, there has been an ongoing multicenter clinical study in the EU which is the results of which are currently under review there by STARZ notified body.
The primary performance endpoint was achieved. It was really overachieved. The endpoint was we were looking for 20:40 or better. So sort of functional reading vision at near 40 centimeters is where you hold a magazine or a book. We were looking for that 20, 40 or better in 75% of patients, but we achieved it in 98%.
So virtually everybody was able to read without glasses after getting this lens. And I'll just share with you a little bit of the data, the binocular uncorrected visual acuity. So this is the real vision that these people had after surgery. These are the patients who are in this clinical trial. The mean uncorrected vision at distance was just over 2020 at intermediate was 2020 at near it was 2020.
So great vision across the entire range from near to far. And look at the improvement in terms of lines of vision. So when you go to the eye doctor, you read down the eye chart, right? Each one of those is a line and we talk about lines of vision, how many did you improve? So distance vision improved almost 10 lines, right?
Because these people had underlying refractive error. Intermediate vision improved almost 8 lines and near vision improved about 6 point 5 lines. So huge improvements across the entire range of vision and great distance intermediate and near visual acuity. Those are the results from this clinical trial. We're looking forward to launching this lens very soon outside the U.
S. So that my friends is the new refractive paradigm. Thank you very much.
Thank you, Doctor. Packer. The presentation, slides and audio you just saw will be available on our website. To those of you on the webcast today, thank you for joining us.