Thank you very much. Welcome, everyone. It's our pleasure today to host our Investor and Analyst Day. This is our second. 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. 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. You'll be hearing from them, and I will mention them during my presentation. The future of refractive surgery is lens-based. The time for STAAR is now. Recently, I attended our experts meeting and the European Society of Cataract and Refractive Surgeons meeting in Paris.
While I was there, one of the most influential leaders in ophthalmology globally, Dr. John Vukich, 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. Dr. Vukich 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. We invited him to be here with U.S. surgeons to talk to you, but he was unable to attend and sent his regrets. 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 STAAR has demonstrated in Asia is a leading indicator for what I expect to happen in the U.S. market. I am opening two 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 will have the first fully intraocular refractive surgery clinic in each location. We are on track to open four 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. 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. 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. The total available market as we see it really includes now for STAAR both myopia and presbyopia.
You're looking at 1.9 billion myopes globally and 1.7 billion presbyopes. Today, refractive surgery really encompasses about 4 million eye procedures, the opportunity is far greater. The way we see it, there are 35 million myopes 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 million presbyopes. STAAR has a huge opportunity with this wave to lens-based technology being in the leading position we enjoy. 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 the chart, by 2050, the expectation is there will be over 5 billion myopes globally.
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. 75%-80% of 45 to 54-year-olds are using some correction today for presbyopia. The numbers are truly astounding, and the number of individuals who tell us they'd do anything to get rid of their reading glasses continues to get greater and greater. Every year today, for vision correction, over $70 billion is being spent. You can see it in eyeglasses, contact lenses, and refractive's 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 Collamer. Collamer is extraordinary. Collamer performs exceptionally well.
You'll hear about that from Dr. 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 STAAR's EVO implantable Collamer 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. The reason why is because ICL advantages are exceptional. The lens is removable, eco-friendly, biocompatible, no dry eye syndrome, upgradeable. There's no capital investment. It's additive, provides excellent night vision, UV protection, and is quiet in the eye. The proprietary Collamer material helps give us this extraordinary capability, and the quality of vision is exceptional. Industry-leading growth, what's been happening? Since 2016, we have been growing very well.
Since 2017 to what we project through 2019, we expect a 22% compound average growth rate. You can see here how nicely this performance is benefiting STAAR when you look at the ICL unit growth being the real engine. Through nine months of the year, you can see that Japan is up 54%, China 50%, Korea 49%, and a total of 35% globally. We thought we'd add a few markets you're probably unaware that we participate in rather aggressively. We've been up in the UAE by 30%, Malaysia 29%, Italy 27%, and down the list. All over the world, we have representation and we have interest, and we're growing. How are we growing? We're growing very well and very profitably. Our gross margin has gone from 68.4% in 2015 to 74.7% 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 a negative operating margin. 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. We've now moved from a negative 7% to a positive 8.5% year-to-date. 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 million year-to-date this year. On the balance sheet, we're happy to say that we have $112.3 million, $78 million 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 U.S., Canada, the U.K., Germany, Spain, and Japan. Our hybrid markets are China, South Korea, and India. This is where we have STAAR 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?" 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. 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. 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. Many of you asked, and rightly so, "How can we get access to some of this information or to some of these individuals?" With their permission, I'm going to play a short segment of what was presented at our experts meeting. First, we'll be hearing from Dr. Zheng Wang from China.
Some of you, I think, probably have already known that the Aier Eye Hospital Group is a huge hospital chain, which has over 400 hospitals worldwide, and over 30,000 employees globally, including 3,600 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. As of last year, ICLs were performed in 145 hospitals by 100 surgeons in the Aier Eye Hospital Group. Yes, there are more ICL centers than number of ICL surgeons in the group. In other words, some surgeons are doing ICL surgeries in multiple hospitals. The demand for ICL surgeons is very high. The training of the trainers is the critical part of standardization. We have train-the-trainers courses, and all the trainers have to go through this test, this process, which tests for relevant knowledge and surgical skills, too.
This year alone, over 100 doctors have been trained in these five 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 EVO 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 three. We have had the benefit, which David Choromanski, 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 Dr. Yoshihiro Kitazawa.
First, I will explain why I moved to an ICL practice. After that, I will explain our clinical results of the EVO and the EVO+ Visian ICL, featuring case report in an ICL practice. This graph shows the degree of myopia of ICL patients at my previous Kobe Kanagawa Eye Clinic. In 2008, most of the patients were in high to extreme high myopia range. Recently, low and mild myopia patients increased, and the average dropped to -6.81 diopters in 2018. There are some reasons why the number of ICL surgery increased in Japan. The first one is ICL have become recognized by Japanese ophthalmologists. This graph shows the survey during the past 10 years among JSCRS members. The percentage of doctors offering LASIK has decreased while those offering ICL has increased. We have currently over 200 clinics offering ICL in Japan.
In the next graph, you can see that ICL has replaced LASIK as the most useful refractive option in the future. JSCRS members were also asked what refractive option they would choose for their own eyes. Again, the LASIK percentage has decreased while ICL has increased. Based on the increasing recognition among Japanese surgeons, they now offer ICL to even more patients in 0 diopters. Japan ICL Study Group performed a multicenter study to compare low to mild with high myopia patient, which was published in BJO in 2018. Based on this study, JSCRS submit a request to JOS, and in 2019, JOS modified the refractive surgery guidelines starting from -3.00 diopters instead of -6.00 diopters. Based on the safety of EVO Visian ICL, recognition among Japanese surgeons and patient awareness has increased. There are some reports of serious complications of laser
What's going on in Germany and Spain? Surgeon support and strategic partnerships have been growing very well. We announced recently strategic partnerships with Vista 49 eye 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 Dr. Neuhann. What we wanted to do is bring you from Germany, the opinion. 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. The majority this year at Experts was talking about the growth of the ICL and how critical it was to their practices. You'll now hear from Dr. Martin Bechmann in Germany.
I'll talk about my personal ICL journey. Here are refractive procedure numbers from the last 5 years. You see the gray bars, which are our laser volumes, light blue is clear lens exchange, and deep blue is ICL. In the first year, it was only a couple of cases of ICL surgery. As you can see here, the deep blue bar is increasing and increasing. 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%-25% of our cases for ICL surgery. 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%.
This somehow shows the dynamic of the process, and if you compare it to the average German market, it's only 4%. Why is that so? Of course, it's because of the excellent results. We all know that accuracy, stability, efficacy, everything's just great from my personal point of view with ICL. 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. 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 higher myopic cases. Now we slipped from -8 to -7, so we are coming down and down. Of course, suspicious cornea or whenever there are any red flags for laser vision correction.
With the cooperation with STAAR, ICL is the fastest-growing segment in our whole clinic. The two of us, the company and of course our 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.
What's going on in the U.S.? We have three surgeons with us today who will give you their perspective on what's going on in the future. I already referred to Dr. Vukich's plans. What's really critical here is bringing this successful business model to the U.S. now. We know that EVO's coming, but we're also very confident that this business model works. Our Chief Medical Officer, Dr. Scott Barnes, who's 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. Our Head of Clinical Affairs, Dr. Jon Hayashida, will give you an update on that later. We did talk about having our inaugural U.S. Surgeon Summit. It was very successful. There's really tremendous excitement among U.S. surgeons, which has led to dozens 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. What you can see here is an ad, "Feeling trapped by your glasses?" You'll hear about more later. This is actually in St. Louis. You can see a billboard that carries this ad. What we found is during the campaign, as a result of it, we had a 200% increase in Doc Finder visits to the website.
There was some real interest, and we believe that the kind of marketing, advertising, digital marketing, social media work we're doing is really paying off great dividends, which David will talk about later. STAAR's execution. Very briefly, we gave you a three-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%-20% promise has actually resulted in 20%-37% annual revenue growth. Our stretch target of +25% ICL unit growth has culminated in 36%-54% annual ICL unit growth. Our profitability improvement to achieving sustainable profitability, positive EPS. By the end of the three years, we actually accomplished all of this, by the way, within two years, that's why we're introducing today in a moment the next three-year outlook.
We from GAAP EPS, as I said earlier, are now in positive territory and plan to sustain it, maintaining improving cash flow. We said we would achieve $25 million of total cash, and as I said, we're well over that and expect to continue this excellent performance. 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. 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 exceptional desirability to win consumer choice and to garner social media enthusiasm.
We're going to support the transformation of the refractive surgery paradigm to lens-based technology through clinical validation and medical affairs excellence. You'll hear from Dr. Mark 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 polymer-based intraocular lenses, monofocal, presbyopic, and accommodating. You'll hear later from Dr. Keith Holliday about our progress in that regard. We are going to deliver Foundations Now 2022. It helped us through the last time. We are taking manufacturing costs down. 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. 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 JP Morgan conference, which is our custom. Our ICL unit growth, we're looking at 35% compound average growth rate by year-end 2022. 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 a 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, we will invest, as I said, in hybrid distribution models to increase our growth profiles in critical markets. We're targeting a total of $4.5 million of reduction in manufacturing costs over the planning period. We expect our operating expenses as a % of revenue will go down by the end of the three-year cycle. We expect our R&D spend will settle into the mid-teens.
Our capital and operating investments will include improvement in expansion of advanced engineering and technology in Monrovia, the opening of Nidau 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 clinicals for the rest of the world. We'll continue our commercial build-out, digital marketing investment, surgeon support, and patient outreach. We truly believe the future of refractive surgery is lens-based, and the time for STAAR is now. Thank you very much.
Thank you, Caren. I'd like to invite Dr. 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. 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. 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. 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 practice.
Subsequently, after I left clinical practice, I've been working with STAAR to look at the global experience with the ICL and EVO as it is today, this has resulted in two important publications. One, a meta-analysis and review on the safety and effectiveness of the ICL. The other, the review of EVO with the central port design. I'll review some of those findings with you today. These are just a few slides here from a presentation I gave in Hawaii almost 10 years ago, when I began doing same-day bilateral ICL. This was already the custom with laser refractive surgery. Everyone was doing both eyes on the same day with LASIK. It was a new idea that you could do intraocular surgery like this, patients loved it, the safety was there to support it.
There was no reason not to go ahead and do the fellow eye right after doing the first eye on the same day. 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." These people were functionally blind. 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. This was life-changing for these people, and that's what inspired me to be so enthusiastic about the ICL. 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 ametropia, which is another way of saying refractive error, seeing well right off the table. They get up and immediately have perfect vision. These types of results are reflected in the literature in general. Here you can see an efficacy index. What's an efficacy index? 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. An efficacy index of one means perfection. That means you see just as well after surgery with nothing as you did before with whatever you had. Look at this efficacy index. It's greater than one with the ICL, up to one and a third. Amazing, right. Accuracy to target on almost 99% within a diopter of target. Long term, it doesn't change.
This graph on the right shows after five years, virtually no change. Excellent results that remain stable in the long term. This is what the literature shows. As Caren mentioned, almost 100%, 99.4% say they'd do it again. That's remarkable. Usually, we're lucky in ophthalmology that we have such great procedures. Cataract surgery is remarkable, right? 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. With the ICL, it's above 99%. It's truly remarkable. These results are also reflected in tangible improvements in quality of life. This is what research shows, that this really improves people's lives, and that's the underlying reason why STAAR is so successful today, because people love this procedure and how it revolutionizes their daily living.
That's really what this is all about. Why is it then that we are still looking at this traditional paradigm of refractive surgery where laser surgery, corneal refractive surgery, LASIK, is still the treatment of choice, quote unquote, for low to moderate myopia? It's because it's been considered less invasive than intraocular surgery, than putting a lens in the eye. Lens surgery has been restricted to higher myopia because it's been perceived that the complications can be, quote, "more disabling than those from LASIK." This is from the American Academy of Ophthalmology. Keratorefractive surgery, LASIK, can be applied across a broad range of refractive errors, but in some circumstances, the surgeon may consider an intraocular procedure. 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 the traditional paradigm, despite the amazing effectiveness and safety that I just described. Finally, this is changing. Here you see the cover of Cataract & Refractive Surgery Today from a year or so ago. Is lens surgery the new LASIK? Here's the article I contributed to that issue, Why You Should Consider Adopting Phakic IOLs. Clearly, there's some movement here, and I think the numbers Caren presented definitely show that there is some movement because EVO is disrupting the traditional paradigm. How is that happening? Remember that the whole reason for the traditional paradigm was about safety. EVO has shown improved safety over earlier models of phakic lenses.
In fact, EVO Visian ICL safety and effectiveness today are comparable to those of LASIK and SMILE, all types of laser refractive surgery, I'll show you those numbers in just a minute. Importantly, EVO demonstrates the same excellent results in low to moderate myopia, which has been restricted to laser surgery in the traditional paradigm. This is one of those papers I mentioned that was published recently, the review of EVO in the literature, I'm going to show you some of the important data that are in that paper. 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 five years. 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. It's a measure of safety. It's asking, did you lose anything by having this procedure? Again, 1.0 would be perfection, means you're exactly the same after as you were before. In fact, it's 15% better than perfection, so it's extremely safe. If you look at the important types of complications that have been a concern traditionally that have restricted phakic IOLs in that traditional paradigm, cataract, 0% out of over 4,000 eyes with five 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 effectiveness? I put together this table to compare EVO with the dominant forms of laser refractive surgery, SMILE and LASIK.
You can see, first 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. Second column is that efficacy index I mentioned. 1.0 would be perfection. Anything above one 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. You can see that EVO is right in there with over 90%, very comparable to LASIK, also just over 90%.
If you look in 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. That means you're 20/20. Negative numbers are better than perfect, and you can see, again, that EVO is slightly better than perfect. Very similar to the other results. How many are 20/20 or better? 97% with EVO, compared to just under 90% with SMILE and just about 90% with LASIK. The effectiveness is very similar across the entire range of refractive error, and the safety is outstanding. This is why EVO is disrupting the traditional paradigm.
This is the study that was 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 myopes, 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. EVO has addressed those safety issues. That's why it's disrupting the paradigm. Satisfaction, that amazing 99.4% you saw is actually the highest of the 3 types of surgeries, LASIK and SMILE. As I mentioned, also, we're very lucky in ophthalmology, people are so happy with what we do.
You can see they're happiest with EVO. 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 phakic refractive lenses. 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. Future upgrades or other procedures remain an option. Don't just take my word for it. How do we know that EVO is disrupting the new paradigm? There are three elements that show this.
One is, first of all, we are seeing literature, scientific literature published comparing EVO to corneal refractive surgery, randomizing patients to one or the other. That's a clear sign that the authors of these papers consider them to be equivalent. Number two, positioning of EVO in clinical practice, you've already heard today that there are now ICL-only clinics, something that 10 years ago, no one would've dreamt possible. Finally, we've now seen the emergence of competitors in this space. You know imitation is the sincerest form of flattery. If other companies want to get in on this, it shows we've got something good. Here first is an example from the literature. In this study, patients were randomly assigned to an EVO Toric lens to femtosecond LASIK or ReLEx SMILE.
30 eyes of 30 patients in each group, 20 to 40 years of age, low to moderate myopia, -3 to -8, with some amount of significant astigmatism and one year of follow-up. What did we find? Well, all three groups were comparable in terms of the basic effectiveness for uncorrected vision. They all did well. 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. Of course, patients reported excellent satisfaction with their vision. 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 José Alfonso from Spain at the experts meeting, showing how he places the Visian ICL in his clinical practice. You can see it spans the range of refractive error from hyperopia to high myopia. There's a very small light blue box where he's still doing LASIK. Everybody else is getting an ICL. In the older patients, the EDOF ICL in the future. For older patients, when you start to get 60, 65, getting closer to the cataract age range, you're looking at refractive lens exchange. Removing a lens before there's a cataract, and then placing a multifocal or monofocal type of lens. Basically, for everyone under 55, it's EVO.
As I mentioned, you can also see this in the purely lens-based refractive surgery practice. Here's an article, published recently in Cataract & Refractive Surgery Today Europe, talking about refractive surgery without a laser. This is a huge benefit, and Caren mentioned John Vukich 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. When you look at the past 10 years of LASIK volume, and you see that the curve is flat or slightly negative, about half a million cases a year in the U.S., there's no growth. You're thinking, "Well, why should I now spend half a million dollars 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 phakic lenses recently introduced outside the U.S., which look a whole lot like EVO, posterior chamber phakic lenses with a central port design. It's been interesting to watch this development. These companies are basically competing on cost because they cannot compete with Collamer, right? That is sort of the secret sauce that STAAR has. When you look down the long road of history of phakic lenses, how many have stood the test of time? Here's a little pictorial display of 16 different phakic 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 million lenses implanted with over 20 years of experience.
We recently saw one of the last lenses standing 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. 10 years later, it started to turn out these lenses were really damaging the cornea, and it wasn't such a good idea. 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 happy. 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 Collamer.
The material really does matter. The new paradigm is finally emerging, this incredible momentum in the global market that you just saw presented. Outstanding effectiveness and improved safety, amazing patient satisfaction, and the expanding range to low and moderate myopia. With over 1 million implants and more than 20 years experience, it's incredible. Now the future is here with two new applications and designs for this lens, the supplemental lens, which is also known as a piggyback lens, and the EDOF ICL for presbyopia. What is a piggyback lens? This is a lens for people who've already had cataract surgery, but maybe the refractive target was missed, maybe because they had LASIK. 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. 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." In the U.S. today, there are no lenses approved specifically for that 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 the lens is a pseudophakic lens now. What's the opportunity here?
Well, almost 21% of patients with a history of LASIK are going to need an enhancement. One in five. That's what I just said. 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 one in five you're going to need another procedure. Don't worry, we have a solution, and part of that solution can be the EVO Visian ICL. 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. That's what it means. 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. It's really disabling.
What have been the solutions for that? Well, we don't have a perfect surgical solution. Now we've come a huge step closer with the EVO EDOF ICL. EDOF means extended depth of focus. It's not a multifocal where you have a near and a far. It's more like a continuous range of focus, more like the youthful eye . It's a more natural way of maintaining near vision. Importantly, it does not require removing the natural lens. 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.
It's great if you can do this, correct their refractive error, correct their presbyopia, and leave their eye completely intact. That's the beauty of the EVO EDOF ICL. As you know, there has been an ongoing multi-center clinical study in the EU, which the results of which are currently under review there by STAAR's 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%. Virtually everybody was able to read without glasses after getting this lens. I'll just share with you a little bit of the data, the binocular uncorrected visual acuity.
This is the real vision that these people had after surgery. These are the patients who were in this clinical trial. The mean uncorrected vision at distance was just over 20/20. At intermediate was 20/20. At near it was 20/20. Great vision across the entire range from near to far. Look at the improvement in terms of lines of vision. You know 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? Distance vision improved almost 10 lines, right? Because these people had underlying refractive error. Intermediate vision improved almost eight lines, and near vision improved about six and a half lines. 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. That, my friends, is the new refractive paradigm. Thank you very much.
Thank you, Dr. 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.