Filmed live at Academy 2019 Orlando
(transcription provided below for reference, please excuse and typos)
Edward Chu:
Good morning. I want to welcome members of the press and the Academy to the 2019 American Academy of Optometry and 3rd World Congress Press Conference. I also want to welcome those joining us on our live feed. Just a quick introduction. My name is Edward Chu. I’m the Academy’s communications Committee’s, on the Academy’s Communication Committee and Press Conference Chair. I want to take this opportunity to thank members of the communications committee, our chair, Tammy Than, Barbara Reese, Arti Shah, Agustin Gonzalez, and Richard Trevino for helping select the presentations that you’re going to be hearing today. Also want to give a big thank you and mention to Kayla Ritten, who did a lot of work behind the scenes to get this put together. She does a phenomenal job and we’re grateful for having her help on this committee. I want to do a quick review of what the format is going to be today. Those of you have attended the press conference in the past and know it’s a hidden gem. We have a lot of information in a short amount of time. You’re going to be hearing 20 presentations each, five minutes in length. You’re going to hear 10 scientific abstracts that are considered some of the best research from this year’s meeting, and you’re going to hear 10 exhibitor presentations on new cutting edge technology that’s changing the way optometrists practice. Due to time constraints and the rapid fire format, we are going to be on a strict five minutes per presenter time limit and we’re going to have to do that to keep things moving forward. So thank you for your understanding. Now before we get started on these presentations, we have a few words from the American Academy of Optometry President, Dr. Barbara Caffery.
Dr. Barbara Caffery:
Good morning. On behalf of the board of directors of the American Academy of Optometry, I welcome you warmly to this meeting. It is a very special meeting, our 97th annual meeting as an Academy. We work towards 100 years and it’s here in Orlando in conjunction with the World Council of Optometry. The World Council has really opened our eyes, expanded our field of view to understand the global problems. So welcome. I gotta go back now. So we’ve been very busy here at the American Academy of Optometry this year. We have a new strategic plan. It’s very difficult to make a new strategic plan. We spent hours and hours at it and I thank the board and all of the strategic plan members for their work, and we have a document now that is available to read. We’d like to just share with you a little bit of it. First of all, our new vision, Inspiring Excellence in Eyecare. It couldn’t be simpler and it couldn’t be more important. Our new mission statement, the Academy will provide exceptional education, support innovative research, and disseminate knowledge to advance optimistic practice and improve patient care. The five pillars that we will stand on are education, research, membership, leadership and legacy, and strategic partnerships. So it’s an in depth document that has a wide range and a lot of energy in it, and the energy is going to come from the actual members of the Academy. This is going to be a living, breathing document. We also hired our new Executive Director, Peter Scott. If any of you haven’t met him, please introduce yourself to him as you walk around. He likes to be called Pete. There’s a lot of Pete’s in in my life these days. Have Pete Kolbaum and two people I’d like to introduce to you at the back, Jared and Pete who are part of our PR group for the Academy, so if anyone needs to arrange any interviews, please speak to them after the meeting. We continue our traditional activities of our Academy, our journal, our sections and special interest groups, our research funding, and our sponsorships, and we’re very proud of the work that we do in that area. Our membership is growing as you can see by this graph rapidly and properly and we’re very pleased about that as well. And our annual meeting continues to inspire excellence in eyecare with lectures and workshops, scientific programs, distinctive symposia, awards and research lectures, our unusually beautiful and exciting exhibit hall, residencts day, and student fellowship. Before I move on to our Foundation, I want to add that this meeting has a lot of exceptional new things. For example, as you sit here through this meeting, the C I T T, Convergence Insufficiency Treatment Trial results will be produced here at our Academy for the very first time, anyone will ever receive them. This is major news and will change practice for the coming years. We have several other things going on. We have a Plenary in which the world health organization will be presenting their new initiative to eliminate preventable blindness by 2050. Apparently there are 2.2 billion people in the world who need optometric help, and we’d like to participate in that.
So let me move on to the Foundation. The foundation is our important arm, our fundraising arm. We are very proud of it. It’s leadership right now, under Pete Kolbaum. The Academy has assets of over $7 million and does every year supply about half a million dollars in grants and fellowships and awards. We have 13 Ezell fellows this year, 80 travel grants provided for people to attend this meeting. Annual Foundation Silent auction is at booth 331 and I’m told it’s spectacular. So if you get to booth 331, please take a look at what’s available. And there is the Hoop It Up Challenge at the Alcon Foundation booth, which is booth 231. So again, this Academy is moving forward with a new strategic plan and new executive director, broad and wonderful goals to improve the eyecare of the world, including the eyecare within our own Countries, Cities, Provinces, and States. And we welcome you here to this exciting meeting. Thank you.
Edward Chu:
Thank you Dr. Caffery. So we’re going to get started with our presentations. So this is the one exception for the five minute time limit because this gentleman is actually going to be giving a talk on a scientific paper that he’s part of, as well as speaking on behalf of EyeNOVIA. So his paper is titled myopia control and evidence-based comparison of the benefits and risks. And he’ll be talking about the Chaperone Study and the Optic Jet Dispenser. Please welcome Dr. Mark Bullimore.
Dr. Mark Bullimore:
Thank you. So before I begin, I make my living working with companies big and small. So, I have no conflicts cause I work for everybody. We’re used to seeing these slides about the volume of the myopia problem and the fact that half the world will be nearsighted by 2050, but that’s a big number, but it doesn’t necessarily help us as practitioners and it certainly doesn’t really inform patients and their parents about what can be done. So a parent might ask things like, how much will my child progress? What’s the risk of eye diseases associated with myopia? Will controlling it by a diopter reduce the risk? And what are the risks associated with treatment? So what I’m presenting tomorrow morning is a quite a bit of evidence based approach, really trying to drill down into the numbers and make a comparison between risk and benefit. Now in terms of the risks we talk mainly about contact lens wear, and we have a lot of data to base our estimates on. So if we start off with say, a medium risk, an incidence of MK of four per 10,000 patient years. So that’s pretty rare. We know from the literature that about 15% of those might lose vision. So we multiplied by 15%, but in myopia with myopia care would probably exposing a child to an additional five years of wear. So we have an accumulated risk of vision loss of basically three years per five years of wear in 10,000 patients. Now if there is vision loss, those patients have to live with it for the rest of their life. So we multiply by life expectancy through to 80 years of age and we end up with 210. Now we can expand that table, the math is all linear, so it’s straight forward. And you can have a low risk on the left, and a high risk on the right.
Why have I chosen those numbers? Well, the low risk on the left, the incidents of one per 10,000 that’s probably our best guess of what the incidents of MK might be in a group of kids wearing a daily disposable lens. At the high end, that’s close to our estimate of what the incidence is for overnight overflow keratology in children. But you can see that the years of vision loss accrued in 10,000 patients wearing lenses for five years is between 53 and about 800. So what about the benefits? Now I know, Brandon and I published a paper earlier this year, but what I really want to focus on here is the data out of Rotterdam. This is an open access paper that reports 15,000 individuals with both visual acuity and refractive erudite. And when you pulled that data, you end up with something like this. This is cumulative risk of vision impairment of three different ages and you can see that the lines are all fairly straight and fairly parallel. The main slope is about 1.25. What does that mean? Each diopter the more of myopia increases our risk of visual impairment by 25%. Turn that on its head. If we could reduce a patient’s ultimate level by a diopter, we can lower the risk of visual impairment in that patient by 20%. Or speaking in terms of the population, we could lower visual impairment among myopes by 20%. That’s a huge public health effect. Now we can come up with a mathematical term that encompasses both age and level of myopia. And you see the business part of the equation is on the line there. And refractive error, a diopter has more effect than one year of age. And I can give you another nice soundbite. The five diopters of myopia is like being 12 years older when it comes to your risk of vision impairment.
So finally, we can draw a family of curves. Looking at visually impairment as a function of age and myopia. And then multiply that by something that we will face, the mortality, a functional title like that. And we end up with this and I just wanted to close on this slide and spend a few seconds. This is basically, the frequency of visual impairment per 10,000 patients at different levels of myopia. So the bottom there you can see that everybody kind of peaks in the early ages before mortality kicks in. But we can integrate the area under those curves. And the area under the curve is patient years and vision impairment. And what we can then see is that, if we can lower somebody by diopter, we can save anywhere from a half to maybe one year of visual impairment in an individual patient. So comparing the benefit and the risks, I’ve already shown you, these numbers on the bottom, if we think about per 10,000 patients preventing one diopter of myopia through treatment should lower the years of visual impairment by between five and 10,000 years. And that far outweighs the risk of vision loss associated with different modalities of contact lens wear. So that’s the summary. The benefits seem to outweigh risks. I’ll be given the full paper tomorrow and I’ll be around at the meeting if you have any questions. So thank you.
So changing hats now, different set of slides, far fewer slides so you can breathe a little easier. So I’m a consultant for Eyenovia, one of the things I should have mentioned on my previous presentation. A lot of that work has been stimulated and sponsored by CooperVision. But I love working with my corporate friends. So we have a problem when it comes to ocular medication and that is our traditional drops. The drops too big for the amount of space within the, on the front of our eyeball. And that has a couple of unfortunate effects. One is we’re exposing the eye unnecessarily, the anterior segment to an unnecessary drug and that can cause red eye discomfort. And we also because of the massive amount of drops that we’re putting into the eye here, we’ve got a risk of systemic absorption, and some of the problems that that might incur. The other problem is we all know is it’s damn difficult to get the drops in, we rely on gravity and a dropper bottle. So one has to assume a certain position and a patient spends a lot of the time putting drops onto their cheeks. And there’s a better way around that of course. So Eyenovia’s unique technology is this Optic Jet, and this allows a patient would be standing upright and basically you put a little spray or mist directly onto their cornea. The size of the dose is much, much smaller, it’s down to eight microliters, and we’re no longer dependent on gravity. So you could do it lying down if you want. But ideally you can do it in front of the bathroom mirror, looking straight ahead and through the side hole. And I know this will be in the exhibit hall and you can try it this yourself and see how the technology works. And the company is exploring a number of avenues, a number of drugs that can be delivered this way. And as already demonstrated, clinically significant efficacy in terms of both reduce in IOP for a glaucoma formulation. And introducing mydriasis for a diagnostic application. There’s excellent safety because we’ve got less drug and it’s going directly onto the cornea, and it shows good tolerability and we’ve got much reduced systemic absorption. And the other thing is it’s incredibly easy to use. I’ll show you a slide in a minute, about our myopia study, but in the first 25 patients that were enrolled in our myopia study, they were all able to use the drug within the running period. And most of the time, and mainly all of the time, it’s the kid that is applying the drug rather than the parent needing to be involved. So that’s really encouraging.
If you want a little soundbite on how this might work, you think of this as a little ink jet printer. It’s not putting ink but it’s using similar technology to just put a little punctuation mark onto the, directly onto the cornea. So in terms of a demonstrated benefits, you get less redness as shown on the top of the upper left there, you can reduce intraocular pressure by a clinically significant amount. That’s shown on the top right. You can get less systemic exposure with phenylephrine which is something we often worry about with our potentially hypertensive patients. And you can get a very nice dilation with a fixed combination of phenylephrine and tropicamide. Now the study, I might be involved in is a study called the Chaperone Study, which has just begun to enroll myopic children around the country and over 12 sites. Many of them are in academic optometry, some of them in private practice of ophthalmology and optometry. And this is a phase three trial of microdosed, low dose atropine. And an important feature of the study is that the children don’t go straight into the study. They have to take the microjet home and demonstrate that they can use it for a period of between 10 and 28 days. And through Bluetooth technology we can also monitor whether they use it, and when they use it, we can’t unfortunately tell whether it went in the eye. But if somebody cheats and comes into the into the practice and says, Oh, I haven’t used it and press it a few times, then busted. Now why is this important to somebody like myself as a researcher? We don’t know enough about atropine. So it’s important with doing two doses here. We don’t have three year data on treatment. This will provide it. And finally, this will take us away from the compounding pharmacies which aren’t regulated by the FDA to the same extent and get away from the potential variability that exists at the moment. So again, come by the booth to see the technology talk to the company and I thank you for your attention.
Edward Chu:
So Eyenovia is at booth 323 and you can hear DSr. Bullimore’s full presentation at the Myopia Super Session tomorrow from nine to 9:15 room W224. So next we’ll have a scientific paper presentation from Dr. Afua Oteng Asare from the University of Toronto. She’ll be talking about the cost effectiveness of school-based vision screening program to detect amblyopia and refractive error in young children versus usual care screening in Ontario, Canada.
Dr. Oteng Asare:
Good morning. Vision impairment is the sixth leading cause of burden of disease due to disability in the world. In Ontario, Canada, an estimated $7.3 billion is estimated to be lost annually due to productivity and treatment costs resulting from vision impairment. In children under the age of six, the two most common causes of vision impairments, as you would all know, is refractive errors and amblyopia. These conditions are extremely difficult to detect in young children but also extremely important, especially with regards to amblyopia, which can cause irreversible vision loss if not detected and treated at an early age. And it usually occurs at about the age of eight. And so in Ontario the standard vision screening strategies to screen as part of well child checks throughout childhood. Also there are optometry exams that are covered through the provincial health insurance program for all individuals that are under the age of 21, once per year. That’s my, these two initiatives, they are not, they are not being conducted as routinely or regularly as we would like. A study, our report by the Ontario Association of Optometrists in 2013, indicated that only 14% of children under the age of six had an eye exam that year. Therefore, the Ministry of Health has introduced in school vision screening for all children aged five years across the province as of 2018. This is a laudable initiative, however, economic data to support the cost effectiveness of such a program are sparse. Therefore I decided to conduct a cost utility analysis to determine the cost effectiveness of such in-school vision screening program compared to usual care screening through well child checks in Toronto, Ontario. Costs were reported in 2019 Canadian dollars, health effects as quality adjusted life years or Qalys. And the analysis was reported in an ICER, which is the incremental cost effectiveness ratio, which is the cost of an additional benefit, unit of benefit, in this case QALYs, of one strategy relative to another. And so specifically I looked at usual care screening as part of well child checks, in addition to a screening offered at age five to children enrolled in public school at the age of five years, and screened by trained screeners contracted to a health unit.
And I compared it to just, the standard which is vision screening as part of well child checks conducted by family physicians. And so we found that for the cost for a single child on average in the public health strategy, cost $23 more than well child checks. And we also found that the public health screening approach was also more effective. So it offered 0.02 of a QALY over the standard well child checks alone. So this presented an ICER of 1,153 Canadian dollars per QALY, or 877 US dollars per QALY. And so therefore, based on our analysis, we found that vision screening as part of public health was more cost effective than the standard well child check vision screening with an ICER of 1,153 Canadian dollars per QALY. And this is comparatively cheap compared to other health programs being conducted in the province, and these results transferrable. Well, while there are some similarities between vision health systems between Canada and Ontario, Canada and the US sorry, there are significant differences, such as an increase in the treatment costs, higher productivity lessons up caregiver sees the need to go with the children to prefer the treatment or well child checks, and also the existence of a fee code for screening in the US. And so I just end here and I invite you to be at my presentation on Friday at 10 O’clock. Thank you.
Edward Chu:
Also, I want to mention that Dr. Oteng is one of the 13 recipients of the Ezell Fellowship. So once again, yes, worthy of applause. Once again, she’ll be giving her full presentation at the Paper Session on Public Health and Vision Screening. It will be Friday, 10 to 10:15 in room W224. Next, we’ll have a presentation from Nova Sight and presenting on behalf of Nova Sight, will be, is it Moshe Barel? All right.
Moshe Barel:
Good morning everybody, my name is Moshe and I’m with Novasight. We’re an Israeli startup company and we are developing eye tracking based pediatric vision care solutions. We have two products, the first is the Eye Swift, vision assessment and the second is Cure Sight for home use and amblyopia treatment. Our technology is based on eye tracking sensors, which provide us with accurate and objective information on vision functions, based on eye movements. We also use artificial intelligence and big data analysis in order to enhance diagnosis accuracy and optimize treatment protocol. Our EyeSwift vision assessment has nine different exams including visual acuity, reading analysis and strabismus measurement. The exams are performed while the patient is watching short animated videos. It’s accurate, objective, fast and easy to use. We’re happy to share that we have signed a global OEM agreement with Essilor for the distribution of EyeSwift. Sales have already started this year, with very positive feedback from the market, and we are already working on the next generation of the EyeSwift.
Moving to the treatment side, the main condition that we are addressing is amblyopia, which affects 3% of the population and is the leading cause of vision loss in children. As you know, the gold standard treatment for amblyopia is placing a patch over the dominant eye in order to force the brain to start using the lazy eye. However, this treatment suffers from very low compliance because it’s inconvenient, it limits the activity of the children, and has a negative impact on their self-esteem and quality of life and it causes strained relationships within the family.
For that purpose, we are developing the CureSight for home use amblyopia treatment, intended to replace the eye patching. The treatment is performed while the child is watching his favorite video of choice, content of choice, through real-time 3D image processing algorithms. The system could auto adjust the treatment protocol, it allows for remote monitoring and it could offer or provide progress reports for both parents and eye care givers.
Here we can see the clinical results of a study we have conducted in Israel on 20 patients between the ages of 5 to 15. As you can see, we have significant improvement both in visual acuity and stereoacuity. Also, with compliance of 95% to the treatment with CureSight. Next year we’re planning to have a randomized control trial mostly centered here in the US. So, Why Novasight? Novasight is the only company to have eye tracking technology for amblyopia treatment. This allows us to offer treatment also for Strabismic patients and adult patients. Being able to run on any content, allows us to offer the most engaging treatment and we do not require any gaming skills or wearing VR headsets. This is our scientific advisory board. That’s it. Thank you.
Edward Chu:
Thank you, if you want to learn more about Novasight and its products, they’re going to be at booth 928 at the exhibit hall. Next, we’re going to have a scientific paper from Dr. Tara Alvarez, from the new jersey institute of technology. She’ll be presenting on CINAPS – Convergence insufficiency neuro mechanism in adult population study: the effect of vision therapy on clinical, objective eye movement and functional MRI measures.
Dr. Tara Alvarez:
Thank you. So, for the last five years, my clinical collaborator Dr. Mitch Scheiman and I have led a registered randomized clinical trial that followed the consort agreement for randomization as well as concealment and this is built on the convergence insufficiency treatment trial (CITT) where we study young adults and CITT study pediatrics. In addition to using their diagnostic terms as well as definitions, we also use two of their therapies – office based vergence and accommodative therapy, as well as their placebo arm.
Now the novelty to our work is that we’re also including objective eye movement recordings and functional imaging. To look at two of the main clinical parameters studied, we looked at near point of convergence for 25 CI’s who are going to go into office based accommodative therapy, vergence and accommodative therapy and 25 that were going into SHAM as well as 50 controlled subjects and you can see that the CI subjects are significantly more receded compared to controls.
For after therapy, the patients substantially improved and the ones that participated in office based vergence and accommodative therapy, improved to the point where they were healthy controls.
For positive fusional range, the controlled subjects had significantly more positive fusional range compared to patients, and after therapy, the patients improved significantly again to the point where they were at the levels of controls.
Now, for the functional imaging, what we did is we looked at a block design task where we have sustained fixation and vergence eye movements which are jump ductions, so we’re looking at a contrast between sustained vision and about eight vergence eye movements. So, if we look at 25 CI patients who were about to be randomized into office based vergence and accommodative therapy, we saw functional activation in the ocular motor vermis, that’s the vermal region 6 and 7 – the primary visual cortex as well as the frontal eye field supplementary eye fields and the parietal eye fields. If we look at those same exact 25 patients after office based vergence and accommodative therapy, there’s two primary differences that are observed. One – we see an increase in spatial extent, that’s the amount of region that’s functionally active, and more importantly we also see an increase in the magnitude or the size of the signal.
If we do a paired T-test on these 25 subjects looking at the baseline compared to the outcome measure, we see significant improvements in the cerebella region, as well as the frontal eye fields, supplementary eye fields and parietal eye fields. Now, if we look at the CI subjects that were going into SHAM therapy, we see very similar baseline data and there’s no significant difference between the CI patients that went into OBVAT, that’s the office based vergence and accommodative therapy, compared to SHAM. But the big difference is after placebo therapy, we actually see very little change in the functional imaging results, if anything they seem to decrease a bit, but when we do a paired T-test on the baseline and the outcome measures, we see no significant difference after SHAM therapy.
I will have full results tomorrow morning, at 8 o’clock in the morning, another key finding that we see is that between controls and patients it’s the ocular motor vermis and the cerebellum that’s actually the most significant difference between controls and patients.
So to conclude, what we’re finding is that office based vergence and accommodative therapy, significantly improves near point of convergence, positive fusional range as well as more functional activity in frontal eye fields, supplementary eye fields, parietal eye fields and especially the ocular motor vermis, and I’d like to thank the national eye institute for their funding. Thank you.
Edward Chu:
Thank you Dr. Alvarez. If you want to hear her full presentation as she mentioned, it will during the hot topics in pediatrics and binocular vision session tomorrow morning at 8 o’clock in room W224 in the EFG wing. Next, we’ll have a presentation from Hoya, and speaking on their behalf will be Dr. Greg Hicks.
Dr. Gregory Hicks:
Good morning, my name is Dr. Greg Hicks, I’m a practice owner and president of three location group practice in northern Ohio, but I also spend half of my weekend on the road as a director of professional affairs for Hoya vision care.
Are all lenses created equal? I think not.
Disturbingly though, less than half of practitioners are reasonably conversent when it comes to talking about some of the lens designs and the differences in lens designs and even equally disturbing is you ask – when you talk to our patients and they do not understand that there is a difference in lenses, it’s got their doctors prescription in it, so what difference does it make what lens it is or what design or what manufacturer. I want to talk about just a couple technologies that makes some differences in lenses, particularly I’m going to start off with the whole series of Hoya’s ID – integrated dual surface design lenses and technology – patented technology that we’re proud of, called binocular harmonization technique.
What’s binocular harmonization about? Well really, it’s a simple word anisometropia. When we looked at our prescriptions over a three-year period of time, generated over the Hoya laboratories across the world, we saw that there were 70% of those prescriptions, that if you looked at the vertical meridian, had ¾ or more of anisometropia.
Why is that of significance particularly with progressive lenses and prismatic effects deviation in down gaze. Now of course single vision lens wearers, that’s not a problem, they just look down. Flat tops, we’ve been able for years to put in some slab off if wanted but with progressive lenses we just tell them to get used to it right?
But, with binocular eye modelling, we can look at the differences of accommodation, convergence, magnification, that vertical displacement as well as create a map of what the image will be with the fused image and now we’re generating ID lenses by looking at what the fused image will be before we start to try with either lens. And this is available in all of our ID series of lenses, particularly though minimizing changing quarter length and curvatures to eliminate that fixation difference in down gaze.
I want to close with our exciting announcement of our Myosmart technology. Our entry into the field of myopia management and myopia defocus therapy. It’s our DIMS technology, defocused integrated multiple segments. Of course, what we’re really looking at here is a honeycomb like design on the surface of the lens that wherever the pupil looks, 50% of the rays of light are focused on the retina, 50% are focused +350 in front of the retina and it’s always a 50-50 focus ratio. Of course, what we really have is a focus zone and a defocus zone. It’s really an interesting lens, in that it has this honeycomb appearance when looking very, very closely and however when we look at the child or the adolescent wearing that lens in interpersonal distance, you really don’t see that focus. Let’s face it, there’s some parents that are not interested in atropine therapy or putting a contact lens on their young child’s eye. We’ve had children now in this lens since 2014 and our randomized study, all of Chinese children at this point, has a 59% less elongation and 60% less progression of myopia and 21% have had no change whatsoever in their myopia. So, we’re hoping to launch this in the US here in the next year, so if you have more questions about that, stop by our booth, thank you.
Edward Chu:
Thank you, Dr. Hicks. Hoya is at booth 1519 in the exhibit hall. Next, we’ll have a scientific paper presentation from Dr. Lyndsey Ferris from the Indiana University School of optometry. She’ll be presenting on “Comparison of vestibular ocular motor screening and sports concussions assessment tool three and NCAA-DOD concussion assessment research and education consortium analysis”.
Dr. Lyndsey Ferris:
Good morning! So, I’m going to take a couple of minutes to talk to you about results from a recent analysis of the NCAA-DOD care consortium, which is the largest multi-site sports related concussion today involving over 30 universities in our US service academies.
So, why concussion?
Well sports related concussion is a growing public health concern. Almost 4 million occur per year and many of those are unreported. So those numbers may even be higher and we know that timely assessment in management is key for these individuals. The concussion in sport group, and international body of experts really sets the standards and unifies the field of sports related concussion and they develop and update bi-annually the sport concussion assessment tool or SCAT and this is a validated multi-dimensional neurological screener that really addresses many of the main symptomatic domains that we see in our individuals post-concussion, but it does have limited visual or ocular evaluation. There’s only two ocular questions on the SCAT and that is – do you have blurry vision or sensitivity to light, as part of the SCAT – 3 symptoms scale. So other commonly impacted visual and vestibular ocular functions such as vergence, accommodation, the vestibular ocular refracts are not addressed at all. So, there’s a gap here. And that’s where the VOMs comes in. the VOMS is the only current sideline assessment test that directly assesses the vestibular ocular system and it does this through a symptom provocation method where we have individual complete certain vestibular and vestibular ocular movements and we see if it makes their symptoms worse.
In a recent study of 417 concussed student athletes participating in the care, we examined their test results at pre-season or baseline to their acute concussed state, looking at all four components, or main components of the SCAT – including the BESS, which is a balance test, the SAC which is a concentration test with a little bit of memory thrown in there, and the SCAT-3 symptom scale, which is more your somatic symptoms, think headache, blurry vision, along with the VOMS and we looked at the predictive power of these tests both individually and in combination.
So, what we saw is that both the VOMS and the SCAT-3 symptoms scale, do a really good job at differentiating between baseline or your non concussed state, shown in blue or kind of purplish, and your acutely concussed time frame, which is your red color up there, and they have a very good effect size. They are both above one and they’re both fairly similar and they don’t seem to be impacted by the ceiling effects that we see both in the SAC and the BESS.
When we use some machine learning on these, using our boosted tree predictive method we see that, yes – the SCAT does do a really good job at differentiating these concussed from non-concussed scores, with an area under the curve at 0.802 and a sensitivity of 78% specificity of 69 – those are pretty good numbers right. But when we add the VOMS to the SCAT we see that predictive power jump almost 4% area under the curb and we get an almost 8% increase in sensitivity.
So when you think about the nearly 4 million individuals that are being impacted by concussion per year, adding the VOMS to the current standard sideline assessment, the SCAT – captures an additional 304,000 people – that’s 304,000 people that we can get into the timely treatment and management that they need to recover and get back to their activities of daily living.
So, if you hadn’t heard about the VOMS, it seems to be a good way to address this gap that we currently see in the Sidelines assessments. As vision care specialists we are part of the healthcare management team and if you haven’t heard about this, this is something we can definitely work with our partners to provide for our patients and bring to the community, to you. If you have more questions, come and find me and come to our lecture on Saturday morning, we’re happy to talk more.
Thank you.
Edward Chu:
Thank you, Dr. Ferris. So, as she mentioned her full presentation will be Saturday morning or almost afternoon – 11:15 to 11:30 during the trauma and concussion paper session in room W224 in the ABC Wing. Next, we’ll have a presentation from Eschenbach Optik and speaking on their behalf will be Timothy Gels.
Timothy Gels:
Good morning, my name is Timothy Gels I’m the director of marketing for Eschenbach Optik, I want to thank the academy and Dr. Chu for giving me the chance to do a short little presentation this morning.
If you don’t know who Eschenbach is, we’re a manufacturer of high-quality vision enhancing products, everything from magnification solutions all the way down to high powered readers as well. We offer programs for optometrists, help them to get started in offering the services that these products are behind and our real goal is to improve the safety, productivity, independence and quality of life of patients primarily who are visually impaired from eye conditions, the biggest being of course macular degeneration.
So today I just want to talk about three new products that we are going to be showing in our booth.
The first is called the Vario Digital FHD and this is a desktop video magnifier. And what’s unique about this is it’s easy user interface as well as a couple of other features that makes it easy for those patients with visual loss to use a magnification solution. The range of magnification is good. At 1.3x – 45 times, has different viewing modes, three brightness settings, what’s called an underline and blinds feature and if you don’t know what those are, just red lines that underlines the text so the patient can find where they’re reading, and the blinds feature just basically blacks out the text at the top and the bottom so they just have one row that they can read. And this product also has something called dynamic line scrolling that scrolls the text across the screen, make it a little easier for them to read as well.
What’s really nice about it is that it folds down, so for desktop video magnifiers sometimes they can be rather bulky, this one actually folds down to only five inches high, so it’s easy to store and also for a person to transport, because it does have an integrated handle as well. It’s also pretty easy for the practice to dispense. Sometimes practices will often times refer out to a location to dispense a video magnifier because it requires an installation at the patient’s home, this device doesn’t require that, so the patient can actually use it pretty well by themselves. There will be also an advanced version of this device. The advanced version will have these additional features like a mirror mode, so the patients can use it for personal care tasks, connection for distance camera, so if they’re going to be using it to look far away, if they’re a student for example trying to look at something like the whiteboard, they can actually connect a distance camera to that, and there will be options for an optional XY table and a battery. There’s also a remote control that can be used too, which can be used both by the patient and practitioner in terms of showing the different features of the product to make sure the patient gets the features that they want.
The next product I’m going to introduce is our FL -41 Rose Filters. These of course are designed for those patients who have light sensitivity from concussions, migraines and blepharospasms. These come in a couple of different tint colors of light and dark and in different frame styles. So for those that wear eyewear like myself, I probably use the fit over style, but for contact lens wearers there’s also a wraparound style too and these are just over the counter versions of FL-41 tints that sometimes will help the practice get the patient accustomed to that and do an RX version later on.
And the last product I want to introduce is what we call our vision binoculars. For a lot of patients with vision loss that are trying to look at different objects that are far away, these are nice because they are called close-focus binoculars. So, most binoculars are used for objects at 10 feet to infinity, these actually will focus down to just 20 inches away. So, a patient can use this to – now we look at this supermarket aisle sign, but when they get up to the aisle, they can actually just focus it down to just 20 inches away and actually look at the object as well. So, it makes for one device that can be used for both at distance and kind of intermediate distance tasks. And because they are binoculars a lot of people like them because they don’t standout. Most people have used binoculars before so they are more familiar to people and they’re pretty compact and lightweight so easy to take with the patient. They do come in 2 different powers there are 4x and 6x so the patient has the choice of which power to use.
Again, thanks for your time and visit our booth at number 808 if you have more questions. Thank you.
Edward Chu:
Thank you, Mr. Gels. So, our next presentation will be a scientific paper titled “Ocular and neurodevelopment outcomes two years after very doses of Bevacizumab for retinopathy of prematurity”, the lead author Dr. Susan Cotter couldn’t be here this morning, so the speaker on the study’s behalf will be Raymond Kraker.
Raymond Kraker:
Thank you. Good morning everyone, my name is Ray Kraker and I direct the activities of the coordinating center in Tampa for a multicenter network of pediatric ophthalmologists and optometrists who study eye disease.
Today I’m going to share with you the results of phase one dosing study that’s evaluating Avastin for ROP and infants and in particular our two-year ocular and neurodevelopment outcomes. Avastin is considered off label use and we did conduct a study under an FDA – investigational drug application and all of our research is supported by the National eye institute from the national institutes of health.
So, a little bit about ROP, retinopathy of prematurity, its characterized by immature blood vessels at birth and these are abnormal growing blood vessels that leads to scarring, retinal detachment, vision loss, blindness, so it’s very severe for these infants. About 1500 cases per year requiring treatment, and it has a huge impact in terms of the quality of life for each child who could end up being blind. Risk factors include – low gestational age, low birth weight, these are very premature babies. Treatments initially was treated with Cryotherapy, freezing of the abnormal vessels and lately it’s been laser surgery, ablation of the avascular retina and more recently medication, anti-vascular endothelial growth factors are injected into the eye to block the growth of abnormal blood vessels by intravitreal injections. There are a few different types of intravitreal medications – bevacizumab, Avastin – and also Lucentis.
There are some advantages with Anti-VEGF treatments, it’s a more direct approach. Blocks the effects of the blood vessels growing and stops that abnormal growth. It’s less time consuming, it’s a very quick injection and several studies have reported rapid resolution, high rates of success and we found that in our study as well. There are some concerns however there’s a potential for Avastin to get out of the eye and into the systemic circulation and this VEGF is needed for the proper development of tissues and some concerns that it could lead to neurodevelopment disability later on in life as a result of it leaking into the systemic circulation. So, our network is currently conducting a phase one, de-escalation study in which we’re trying to find the lowest dose of Avastin that can successfully treat their ROP and by finding the lowest dose, we might have a less chance of having any neurodevelopment issues later on.
Today we’ll look at the 24-month ocular and neurological findings. So major eligibility criteria, these kids had to have type I ROP in one or both yes and they had to have had no treatment for ROP previously. We did initially study four low doses of Avastin, starting at 0.25 mg and then we have the dose along the way, all the way down to 0.031. The fellow eye, most of these kids have bilateral ROP and we always treated the fellow eye with one dose higher than the experimental dose, so they were always treated with the last effective dose. Here in the second row we did see a very good efficacy across the doses, all the way from 0.25 down to 0.031 and we have – we’re now studying up to additional five doses with IRB and the SMC approval.
So, today I’ll share with you the two-year outcome for these first four levels, we had 36 infants complete the two-year ocular exam, which included assessment of an ocular exam as well as neurodevelopment assessment by the Bayley. The cyclopedic refraction at two years in these infants was much better than with laser. We have only 14% with myopia. Very minimal abnormal ocular findings and only one retinal detachment and 28% with strabismus. The Bayley as I mentioned is our primary interest for neurodevelopment growth and cognitive skill, language skill, motor skill, these are things that we evaluated over two years. We did end up having 29 children complete the testing. The range of scores is 45 to 155. We have significant impairment as marked by a score of less than or equal to 70 and in fact we see almost half of these infants have significant impairment at 2 years with respect to the Bayley scores and there’s no trend with dose in terms of high to low dose that we’re seeing, there’s no correlation at all.
So, in conclusion, no strong correlation between any dose that we studied in neurodevelopment outcomes. It’s under powered to conclude that there are no correlations and the rates of ocular outcomes are consistent with rates reported for higher doses. Thank you.
Edward Chu:
Thank you. You can hear the full presentation tomorrow morning from 8:30 to 8:45 during the hot topics in pediatrics and binocular vision session in room W224 in the EFG wing.
Our next presentation will be from Konan Medical, USA and speaking on their behalf will be Ian McMillan.
Ian McMillan:
Good morning everyone, thank you for being here. I want to talk about two new products.
Number one is a product called Eye Kinetics, this is a second generation pupilograph and secondly, I want to talk about a product coming next year which is objectiveFIELD.
So, Eye Kinetics is our second-generation device for objectively assessing RAPD’s and other pupil measurements and this is a replacement for what is a century old test that really hasn’t changed much.
So, it accurately assesses pupils in less than a minute, its small, its inexpensive, and it allows you to delegate a really important part of the eye exam to your techs with confidence. It includes other measurements, including a photopic and scotopic pupil measurements, interpupillary distance. So, with a minute of testing, you get a RAPD test and almost all of PERRLA, except for accommodation.
So, Dr. Guitierrez is the chair of the Texas Optometry board, he is one of the early adopters of the technology, has two devices in the clinic. He’s already fighting pathology in otherwise asymptomatic patients, so this is his feeling on using the device for the first couple of months.
Next, I want to talk about a product that’s coming later next year, its ObjectiveFIELD, as far as I know it’s the only objective perimeter, so there’s actually no button to push at all. Fixed test time – seven minutes- separated into 9 segments of 40 seconds. Absolutely no patient response required, they just need to look straight ahead and not fall asleep. You get a 30-2, 24-2 both eyes, in one round and because of it testing both eyes simultaneously you get an asymmetry report. The brain child of professor Ted Maddess who invented FDT and the Matrix, just acquired just over a year ago from Australian national university and this is what the device looks like. So, the patient lines up and this is a simulation of what the patient thinks they see and this is brightened up for demonstration purposes. And this is what is actually going on, so each eye being stimulated completely independently and all this is happening much faster than on the screen. These presentations are happening five presentations in one second. Again, with no response needed by the patient.
So, this is what’s really going on. Again, each eye being stimulated independently and under infrared conditions we’re recording the very minute cortically mediated pupil reflexes. Or actually pupil responses sorry.
And this is what the device sees. So, you can see these very, very minute pupil responses that are measured in microns for the amplitude and we measure the velocity of the responses as well, in milli seconds and we also measure the delay of the response, and from there we map the visual field.
So, the benefits are –
Number one its objective.
Number two the test time is relatively fixed, so higher workflow, higher throughput. The room doesn’t get clogged. Its tolerant in blinks and fixation losses, so we need 85% data collected for each run, but if there’s this real time feedback, so if there is a segment that we need to collect more data, we just repeat that 40 second segment.
And we have a good correlation with RNFL loss, studies are on our website if you care to have a look, and if you have any questions, we are at booth 1211.
Thank you.
Edward Chu:
Thank you, Mr. McMillan. All right, so at this point we’re going to have a short break. Help yourself to some coffee and some breakfast, then we’ll restart around 08:35.
01:06:27
To start the second half of our press conference, we have Dr. Tammy Than from the Dublin VA Medical center in Georgia, she’ll be speaking about the efficacy of single administration of 5% Povidone – Iodine in the treatment of Adenoviral conjunctivitis.
Tammy Than:
Good morning. So, of the 50 serotypes of adenovirus over 35 of them can cause conjunctivitis. Adenoviral conjunctivitis as you know is contagious and these patients are highly symptomatic, however there is no FDA approved treatment for this condition which can be so miserable.
Currently our standard of care was palliative. Artificial tears, lubricants, lubricants or cold compresses, however a few things have been used off label, including betadine or that’s also called Povidone Iodine and you’ll see it in the talk referred to as PVPI for that abbreviation, but there’s no real scientific evidence to support that, although anecdotally a lot of people believe that it works.
I’ve been fortunate to be part of a RAPID study group – RAPID stands for reducing adenoviral patient infected days – we’ve been awarded an R34 planning grant and so I’m presenting the pilot study data.
We looked at the efficacy of a one time in office dose of the 5% betadine. There were nine sites that recruited where the recruitment lasted over 3 years, with the intent of randomizing 50 patients into the study. The criteria in the patients had to be 18 years or older, their first involved eye had to be red or symptomatic for four days or less and one of the key criterion is that they had to be positive on the RPS adeno detector, which is a point of care amino assay to confirm whether a patient has adenovirus or not.
We went through a symptom survey, a slit lamp exam, we collected samples for delayed and bath QPCR at a later time, as well as some other assays. These patients were then randomized to either receive a one-time dose of betadine the 5% ophthalmic or artificial tears. We then had them return for over a period of three weeks, we looked at them five different times. And so, you’ll see here, we screened over 200 patients, 56 of them were enrolled and they were broken down into two arms. We had 26 in the artificial tear group and 30 in the betadine. Interestingly if you can see down at the bottom, what we’re looking at today really would be the ones that were QPCR positive, confirmed that they had viral titers, and you will see that 12 of the 26 artificial tears were QPCR positive, even though they were all RPS adenodetector positive to get enrolled. And then we had a 16 of the 30 in the betadine group. So, 50% of the patients that tested positive for our point of care test, actually had confirmed PCR Viral titers.
So, what I want to show you here is the graph looking at the two different groups. So, the open circles are the patients who received betadine one time in the office and the closed circles are those that received artificial tears. All of these data points were normalized to the patient’s peak titers and the intent was to try to minimize some of the biases for example like sampling differences between the clinicians. You’ll note that the Y axis here, it’s a log scale, so you’ll notice – and these are the time points that we looked at the patient. At Day 4 there is a statistically significant difference between those in the betadine group and the artificial tears. Now remember this is log scale so the differences here, the artificial tear group compared to their peak titers was at 14.4% at day 4, whereas the betadine their peak titers compared to that, there was only 2.5% of the viral titer at Day 4. There was definitely a difference in the QPCR findings at day 4 in the two treatment groups.
This next graph compares their symptoms. We did a symptom score on 10 different symptoms scaled from 0 – not bothersome to 10 – highly bothersome and the gold color are those that received artificial tears, the orange is the betadine group. And you will see at day 4, in these patients there was a difference. That was the only day throughout the study that there was a difference, but the patients that received betadine felt better at day 4. The ones that are starred, you will see those were statistically significantly different but the patients were feeling better at day four, and how did they look?
Here is the sign – so the clinic has the same kind of findings, so the betadine group their signs – we scored those from 1 to 5, 1 the sign was not present versus 5 it was obviously present and you can see that those patients that received betadine were looking better as well.
So, our summary – first of all we found that betadine was well tolerated, there’s been some concerns about tolerability, the patients tolerated it. And we also found that at day 4 we see a trending down of the viral titers, the patients feel better, they look better to the clinicians. So, if you want to find out more, the presentation is tomorrow and we also have three different posters as well on this topic. And this is a lot to look at but I want to thank – I’m only one of a great team that has been working on this research. So, thank you.
Edward Chu:
So, as Dr Than mentioned she will be giving the full talk tomorrow during the hot topics and anterior segment session in the Tangerine ballroom. So, our next presentation will be from Alcon and speaking on their behalf will be Dr. Mohinder Merchea.
Dr. Mohinder Merchea:
Good morning. On behalf of Alcon I want to thank the Academy and our media partners here for giving us the opportunity to share some information about Alcon’s latest innovations that we are introducing to the US market. Alcon’s very excited about launching our latest Silicon hydrogel daily disposable contact lens innovation – Precision 1. This lens builds off of Alcon’s experience and legacy of water surface technologies and our focus of bringing unique materials for different patient needs to market. Our target with this lens has been those patients that are seeking long lasting comfort throughout the day. With Precision 1, this lens uses Alcon’s proprietary smart surface technology. What this is, is a permanent micro-thin layer of moisture, about a micron thin that helps to provide a very stable tear film and exceptional comfort and vision throughout the day.
Additionally, what we are finding with this lens is that even for those patients that are new to contact lens wear – it provides phenomenal handling. There is a lot of Precision 1 data that’s being presented at the Academy meeting. We actually have about five different presentations over the course of the week here detailing the science, supporting Precision 1 and demonstrating its performance as kind of the newest innovation in the daily disposable category. What you will find in some of that data is just some fantastic outcomes with respect to end of day vision and comfort and overall handling as I was mentioning.
In addition, Alcon’s very excited about introducing our latest IOL innovation. This is a product that’s being available outside of the US for several years and after well over 20,0000 implants it’s now entering the US market. We launched it last week in the US. This is a AT- IOL, advanced technology IOL for the Management of presbyopia in cataract patients, the PanOptix Trifocal IOL. With the introduction of PanOptix, we are really excited about finally being able to offer cataract patients the possibility of 20/20 vision at distance, intermediate and near using a single IOL design in both eyes. So unlike other diffractive IOL technologies, there is no mono vision, there is no mixing and matching of different designs. This is a design that helps patients see with uninterrupted vision across their visual range.
What’s unique about this design is that it has a 60cm intermediate working distance and again very unique amongst all Trifocal IOLs that might be available outside of the US in very clearly a differentiating innovation for IOL technology in the US. These are the FDA results – again fantastic outcomes with the use of this product in this trial, probably the most telling outcome there is that over 98% of patients would recommend this to a family member as well as that over 90% of patients said that they were less reliant on spectacles after surgery demonstrating the exceptional range of vision that we are able to provide with this IOL.
The results are going to be two posters presented on the PanOptix IOL at the Academy. Again, this is just another great example how our optometrists can help educate our patients in terms of IOL selection and maximizing their potential after cataract surgery and not having to deal with presbyopia.
So, with that I will thank you and have a good rest of the morning.
Edward Chu:
If you want to learn more about Alcon and its products, they will be a booth 916. Our next presentation will be from Johnson and Johnson, and speaking on their behalf will be Dr John Buch.
Dr John Buch:
Well, good morning. I’d like to share with you the results of the clinical study that evaluated the ACUVUE OASYS with transitions contact lens on a population of contact lens in neophytes.
To disclose myself and the co-authors are employed by Johnson and Johnson vision. And just to show you the lenses that we use – we did use the 8.4 base curve lenses, minus 1 through minus 6 in this study. The lenses were worn as daily wear reusable and the lenses were replaced after two weeks.
This graphic just shows you the overall study design, basically the lenses were the fit and dispensed for one month and we had follow-up visits at one week, two weeks and four weeks after dispensing. At the end of the four weeks, subjects were put back into their habitual lenses which by the way the habitual lenses had to have been current within the previous six months, and they had to have worn those lenses for at least two weeks before entering the study.
So, they were put back into their habitual spectacles for one week and then at visit 5, we asked them questions pertaining to their contact lenses and their spectacle wear. Just as a quick note, subjects that wear these lenses really need to wear them for at least two weeks to experience the benefit in different lighting situations – it’s just a quick comment. That’s kind of an eye chart, but the gist was we had 129 subjects enrolled, 127 were actually dispensed lenses. Of those 127 then made these safety populations; so, with the safety populations what we analyze are bio microscopy and our fit success rates.
It’s kind of hard to see but when you go down the list, over the course of the month several people will drop out and by the end of the study we had a 105 cohort subjects. The cohort subjects’ demographics are shown there on the right. We used this for efficacy measures, so like this subject of responses are based on the cohort population.
If you look at fit success rate – so, we had 11 investigational sites spread across the US. They judged the successful fit based on physiology subject to comfort, vision and handling. And all lenses in the study had an acceptable mechanical or physical fit and what we know is from the safety population that a 121 and over 127 subjects were judged to have a successful fit or a fit rate of about 95% and if you just look at those that actually made it to visit four, the fit rate was about 98%.
Okay, then at visit 5 we did ask several questions, a variety of questions and some of them dealt with benefits to lifestyle and it’s important to know that all these questions had a balanced response set. So, they had two levels of agreement and two levels of disagreements with each question and of course there was a neutral response as well. So here if you look at benefits to lifestyle, if you look at just the top two box responses, about 80% of the subjects come in at the lens perfectly met their lifestyle, their active lifestyle; 86% said that their day was less disrupted by light and finally 85% said the lens was perfect for them for sports or exercise.
Looking at some different type of questions. We have a little over 60% say that they would actually purchase the lens after the study. Interesting one – there was 71% said that they would recommend their eye doctor if that eye doctor had introduced them to the lens, had suggested the contact lens to them. We had a full 95% said that they would recommend the lens to others after the study and almost 90% said that they are likely to wear contact lenses in the future.
And some of the other questions that we looked at actually compared the photochromic lens directly to spectacles and here we have about 60% of the subjects responded that they felt the contact lens gave them better outdoor vision, a little over 60% said that they squinted less with the contact lens.
Little over 65% said that they were bothered less by bright light and almost 70% they actually experienced better or soothing vision with the photochromic lens compared to their spectacles.
And finally, we asked them which vision correction would you prefer to wear in the future? So this is after they’ve worn the lens for a month and they are back in their spectacle lenses and they had the option is do you want to continue wearing just contact lenses, do you want to go back to wearing your spectacles or do you want some combination of both? And 92% of the respondent said that they wanted to include the ACUVUE OASYS with transitions lens of part of their vision correction. And some of that is in conjunction with spectacles, but they did want to include it as part of their vision correction options moving forward. So just in summary we know that transitions had really strong performance compared to spectacle-only wear in this population. We know that 9 out of 10 subjects actually want to continue wearing the photochromic lens as some form of correction moving forward and just as a reminder again subjects really need to wear the lens at least two weeks to experience the benefit of the lens in different lighting environments. It’s kind of and eye chart, – the gist is the lens is a very strong UV blocker but it doesn’t block, doesn’t cover the eyelids, the external part of the eye, so it’s not a replacement for sunglasses. Okay. Thank you.
Edward Chu:
Thank you, Dr Buch, and if you want to learn more about Johnson and Johnson, they will be a booth 1201 in the Exhibit Hall. Next, we will have a scientific paper presentation from Dr Christopher Clark from the Indiana University SChul of Optometry and he will be presenting on Detecting Retinal Changes Using Machine Learning in Diabetics without Retinopathy.
Dr Christopher Clark:
Hi. Thanks for inviting me. Diabetes is estimated to have up to 600 million people worldwide with diabetes; 200 million of those will be affected by diabetic retinopathy throughout their lifetime currently.
Diabetes in this country at least is primarily diagnosed through blood sugar levels currently specifically through hemoglobin A1C levels with a diagnosis of 6.5 and above on two consecutive visits being considered diabetic.
Unfortunately, diabetes in A1C levels as relatively poor for sensitivity and specificity for detecting diabetic retinopathy because it’s a chronic disease and a person could have a low hemoglobin A1C level and still have retinopathy if they have had diabetes for 20 years or so.
Here is an example of three different patients. The top one is not a diabetic with no retinopathy, the middle one is a diabetic, again no retinopathy. You can see that they are actually very similar, you can’t see any difference between these optical coherence tomography images; in the bottom line from a different OCT but it shows the retinopathy existing with macular edema.
So, these are three very different conditions but they might have very different A1C levels. Machine learning has already been developed to detect diabetic retinopathy and it’s a very important thing to have but it’s obviously pretty obvious when you look at these images who has diabetic retinopathy and who doesn’t.
So, one interesting thing for an optometrist and primary care optometry is who is going to become, who is going to develop diabetic retinopathy rather than who already has it.
Well, we already know at sub clinical levels we can see through that of optics imaging done at IU that there are actually vascular changes much earlier on in the retina before they start to develop retinopathy. So, let me ask an interesting question of whether we could use machine learning to start to detect changes in the retina structure before the development of retinopathy? And so what we did was in a 8766 diabetic patients, we looked at patients without retinopathy whatsoever, they all had diabetes, what we wanted is to do is see we could correlate changes in a A1C levels with changes in retinal structure that are not detectable through current means, through fundus exams TFEs and through traditional OCT fundus photography. So, we divided those up into two – that’s actually two groups, a higher group and a lower group based upon A1C levels. We built machine learning models doing this and we did that by basically dividing by the A1C levels, so if you are above say a 6.5 level you are above it or below it when you ask the machine learning can you detect who is in which group.
Here is an example of one of those plots. On the left we actually have an ROC curve where we are showing the specificity and sensitivity at a 6.0 A1C level. So, we are actually just trying to detect changes in the retina purely based upon the A1C level rather than actually through any retinopathy that exist currently though fundus photography DFU or a CT which all these went through. And then on the right there you can see actually every plot of every A1C cut off level where we actually increase in our detection level as we have increased levels of A1C. So, the next future stuff for us is really to look – is this a screen for patients with high risk for developing retinopathy, can we reduce unnecessary visits for diabetes with otherwise healthy retinas and could it be used to detect systemic diabetes in patients who haven’t been detected yet? Thank you.
Edward Chu:
Thank you, Dr Clark. So, he will give his four presentations tomorrow during the hot topics in artificial intelligence session from 8:30 to 8:45 in the tangerine room, sections 3 and 4. Next we will have a presentation from Zilia and speaking on their behalf will be Johnny Deroche.
Dr Johnny Deroche
Good morning everybody. So, my name is Johnny Deroche. I am clinical application specialist at Zilia. We are a start-up company in Quebec City Canada and we develop ocular oximetry tools. So, to get started, I am going to show you a short presentation summarizing what Zilia’s mission is all about.
Imagine living in the dark all day long. For most people blindness is the biggest fear of all. Unfortunately, vision loss is all too common and, in many cases, it could be avoided. The three main causes of vision loss are glaucoma, diabetic retinopathy and macular degeneration and their prevalence will increase dramatically by the year 2030. Nowadays these diseases are diagnosed by looking at science of damage to the eye which often means too late. What if we could intervene sooner and better? Scientific evidence shows that these diseases are linked to oxygen regulation in the eye. What if we could measure this using just light? We could identify issues before irreversible damage or cures. We could treat diseases earlier and use this critical information to develop better treatments and better drugs. We could help prevent blindness for millions of people – introducing Zilia, a unique thought firm technology based on imaging, spectrometry and artificial intelligence that enables the non-invasive measure of oxygenation in the human eye. This new approach can revolutionize eye care and we are looking further and beyond. The eye is a unique window into someone’s house. Our platform technology can be applied to a variety of fields from neurology and intensive care to pharma research. We are on a journey to save this sight and improve the health of millions.
So, the platform technology that we developed named Zilia Ocular, really brings a paradigm shift in ocular disease management. As you may know, current imaging modalities for the diagnosis of ocular diseases focus on anatomy but really lack functional and metabolic data such as tonometer’s, visual fields, retinal camera or OCTs. With that in mind oxygenation is an important marker of metabolic activity and responses and, therefore, is linked to many ocular diseases, and this has been shown in more than 125 papers in the last five years. What we developed is the first fundus camera to measure accurately and continuously oxygen saturation in the human eye. The platform that we developed, both the hardware and software, is shown here and as I said it provides accurate, quantitative and real-time oxygen saturation measurement in a non-invasion fashion.
So, it’s now launched on the investigational market, so it’s an investigational device and we are currently building our manual database to see what’s the normal and diseased oxygen levels for glaucoma, for example. So, if you would like to know more, come see us at booth 224, we’d be happy to show you a demo.
Edward Chu:
Thank you. Our next presentation will be from Iris Vision and speaking on their behalf will be Tom Perski.
Tom Perski:
Okay. Good morning everyone. I am Vice President and Chief Product Conventionalist for Iris vision. Iris vision – irisvision.com doing businesses. Iris Vision Global was a Silicon Valley company that began several years ago. Our founder Dr Frank Werblin is a neuroscientist from Berkeley. He’s been working with Dr [inaudible 01:31:40], Dr Johns Hopkins and they developed an idea to use virtual reality for low vision patients who were at the end stage of their diseases.
We are the only product in the marketplaces, new marketplaces called wearables now with low vision, That is backed from the research, from the National Eye Institute and with help from Stanford University and John’s Hopkins we’re also venturing into the whole world of tele-health in being able to help the patients actually be –not only he use it as a visual aid but be able to monitor their vision throughout the day, have that data sent back to their doctors and this will be a ground-breaking invention in the sense of it.
We have never heard many of the types of things that can happen him with a low vision aid to be able to actually intervene with someone. So, we are working with of course severe low vision and we were at 2800 down the – perhaps 2100 acuities and macular disease of course was our number one target. Over the last two and half years we’ve developed some really interesting algorithms for different eye conditions. So, for instance, souls with field restrictions can actually use this product, you know, I will mention that briefly in a minute.
We are using – actually partnering now with Samsung Corporation. So, we are using Samsung’s, we call it Gear VR – a hardware and of course we’re a software company that uses the processor in the camera and the imaging of a smartphone right inside the Samsung headset which works out actually well. One of the advantages of using a system like this is this is Wi-Fi enabled. So, a person can receive upgrades through the actual device. So, as we have commercialized now over 3000 patients, we – about every three months, we develop new features that can be pushed through the device at no charge to the users. Also, remote support now that we have expanded into Australia and Europe and into Canada. We have many people who maybe would call us for troubleshooting – there is something that doesn’t seem right, we can anywhere in the world log right into the person’s device and usually fix it in two or three minutes which works out really well.
We developed also for visual tasks; like reading distance, television watching, playing cards, especially music – things that are really difficult in low vision to be able to do. This system automatically focuses instantly no matter where you look. And so, it’s been great to see patients have a very immersive view of the world where you – when you use VR, things that are right up close. The illumination is very, very strong. It can work in the dark environment, for instance, with patients with RP or glaucoma. I myself, I am visually impaired – I have been living with Stargardt’s, a macular degeneration since I was in college. And so been in the field of low vision rehabilitation myself for 35 years and worked as the Senior Vice President of the Chicago Lighthouse for the Blind for 10 years, and we did a study there of all the wearable devices and this one was the one that was chosen by far by all of our patients at the low vision center.
So, we have got a lot to talk about in the future as I mentioned for telemedicine and we are looking forward to talking more about that with you. Please come and visit our booth and we will explain more. Thank you.
Edward Chu:
Alright. Thank you for that presentation. Our next speaker will be Nahida Akter from the University of New South Wales. The presentation topic is a future agnostic-based glaucoma diagnosis from OCT images from deep-learning technique.
Dr Maitreyee Roy:
Hello. Good morning everyone. I am Maitreyee Roy from SChul of Optometry and Vision Science, Sydney, Australia. So today we are here to present our work on glaucoma where we are using artificial intelligence to detect and identify glaucoma.
So, as we know, the glaucoma is an ocular disease where optical nerve had damaged, can causes peripheral vision loss. So, as you can see in this picture from normal vision to the severe glaucoma patient; they can see this vision. So, if it is not treated early, then that may lead to complete blindness. So here I have one of my PhD students Nahida Akter. She will be taking you through this whole process and we will be presenting here our preliminary result. So, it’s over to Nahida now.
Nahida Akter:
Thank you, Dr Roy. So why we are doing artificial intelligence in glaucoma? We all know that glaucoma is a complex multifactorial irreversible disease and it is increasing prevalence over time. 50% are being undiagnosed around the world and currently available most popular OCD scans with different retinal layers become well-known clinical features to train them in artificial neural network. We know glaucoma is a multi-factorial disease and the clinicians can’t rely only on structural or functional features to diagnose glaucoma. So, in our project we are using both structural changes and functional features to or to detect glaucoma and classify the stages of glaucoma from early to severe stages. For auto-detection of glaucoma, we are using deep-learning method and for glaucoma classifications we are using machine-learning. Different types of classifier we use to classify the stages of glaucoma. So, in the methodology you can see for the deep-learning we are using the [? 01:38:59] OCD scans or temporal superior national inferior, temporal retinal profile to train our deep-learning to classify glaucoma and normal. We trained more than 400 images to train our deep-learning architecture and after the output of the deep-learning, we combined with the functional features that are age, CDR, MD PhD BFI and combining them and then we trained our support factor classifier which is part of machine-learning. So, we trained our classifier and it can successfully classify from normal to severe glaucoma.
Here our preliminary results – we are showing our results through the confusion matrix. So here you can see from the deep-learning we got normal 100%. I mean the accuracy of normal was detected as 100% and glaucoma detected 92%. And the results of ML are better than the DL when we combined all of the features together and train our ML classifier. So, then we got overall 97% accuracy. So, for, just for normal, advanced, severe you can see here we got 100% and for early it was detected 88% accurate and 12% means classified -as in normal.
Furthermore, we use TSNIT retinal layers also to detect early to severe and from early, for early we got 48 accurate ML of 51, for advanced we got 21/21 and for moderate we got 12/13, and severe we got 10/10. So, this is a very good result we hope, and in conclusion we can say the performance of the DL results that was trained from the OCT images of TSNIT retinal profile is much better than the previous studies. The six functional features combined with DL model classify the glaucoma stages from early to severe and more accuracy could be achievable in future with training more datasets. The proposed AI method could be considered as a standard clinical feature to detect and classify the stages of glaucoma.
In a nutshell we can say our research goal is to develop the AI for accelerating diagnosis process, relieve the clinicians from manual data analysis and misinterpretation. If you want to know more about our research, please come and join in my talk tomorrow at 8:00am – hot topics in artificial intelligence. Thank you all.
Edward Chu:
Thank you for that presentation. Our next speaker will be talking about her scientific paper titled Rates of Visual Field Progression in Glaucoma: 10-2 versus 24-2 Test Patterns. So please welcome Dr Nicole Charry from the New Medical VA Healthcare System.
Dr Nicole Charry:
Good morning. So, this was a research study conducted out of Albuquerque, Murphy VA Medical Centre and we evaluated the rate of progression with comparing the 10-2 and 24-2 visual field test. No financial disclosers. So, the basis and purpose of this study – while 24-2 visual field testing has traditionally been used for detecting visual field loss in glaucoma, the 10-2 visual field test is only recently been recognized as a potentially important supplementary test for detecting and monitoring glaucoma as visual field loss.
Little information has been published so far regarding the utility importance of 10-2 visual field testing for detecting progressive visual field loss.
So, this study was designed to and compared the rates of glaucoma visual field change between 24-2 and 10-2 visual field tests to determine if there is any advantage of one test over the other.
So just a brief overview of the methods – to be included in the study you had to have a diagnosis of primary open angle glaucoma or glaucoma suspicion. The 10-2 and 24-2 visual field tests using the Humphrey Field Analyzer were alternated generally at 4-6-month intervals and all subjects were required to have at least 5 good quality tests of each type. The rates of MD change per year on the 24-2 and 10-2 tests were calculated using linear regression analyses. And we explored the following variables with age, stage of disease, severity of visual field loss at baseline and then the presence of a 24-2 defect at baseline.
So, there were 77 primary open angle glaucoma subjects. There were 56 primary and there –77 open angle patients and then 56 glaucoma suspects. Just to note that most of the glaucoma patients were just mild disease stage. The average age was about 66 years and the primary open angle glaucoma group and about 61 in the glaucoma suspects. The subjects were comprised primarily of Caucasian and Hispanic patients.
So, this chart kind of summarizes the comparison of the rates of progression for the 24-2 and 10-2. We did find that the rate of progression was fairly slow overall and that it was little bit faster as expected with the primary open angle glaucoma group.
And this chart just kind of summarizes the comparison of the rates of progression for the 24-2 and 10-2 group. And so, we didn’t find that if there were very few, I would still have any change of 1 decimal per year, so this kind of shows that, kind of visual representation of that.
Okay, so in conclusion we found that because the rates of 24-2 and 10-2 visual field loss were similar in the study, serial testing using the 10-2 pattern appears to offer little additional clinical value versus these standard 24-2 test pattern for early glaucoma patients. Thus, while the 10-2 may have value for episodic testing in glaucoma, the study does not support 10-2 replacement of the 24-2 or frequent regular testing using the 10-2 for monitoring early glaucoma. Thank you. If you would like to hear more about the research, we will be presenting this afternoon at 2:30.
Edward Chu:
So, as Dr Charry mentioned she will be presenting during the glaucoma super session, it will be at 2:30 at room W224 in the ABC wing. Next, we will have a presentation from Innova Systems and presenting for them will be Dr Jerome Sherman from the Suny college of Optometry.
Dr. Jerome Sherman:
Thank you very much, very nice being here, it forces me to sit in and I’m learning about all new technologies, which is incredible and I’ve seen a lot of changes in the last 50 years and its actually difficult to retire because things get more and more exciting every year.
Anyway, we’re here to talk about the Rabin Test, which is a functional test of color and contrast simultaneously and we all know there are a lot of disorders out there and we have about 50 million Americans nowadays that have AMD, Glaucoma and diabetes all put together and a lot of tests exists, but this is a test that’s under-utilized and actually the two components are under-utilized. Color vision is underutilized and contrast sensitivity is under-utilized. Here they are paired together and it’s very, very useful to do this.
The kinds of conditions that we find that affect color contrast vision, retinal conditions, Mac Degen, Diabetes, RP – all the various kinds of glaucoma, and even a lot of neurological disorders can be detected with this technology and this is something you should look at – hopefully its working, and what we’re really looking for is a threshold, we’re using three different colors, red, green and blue and we’re really trying to identify this threshold of your ability to see those letters.
So, it’s like a visual field in that it’s a threshold test, but we’re using three colors and we’re doing it centrally. It’s not peripherally, it’s with full view fixation.
We know that Rabin Cone is effective in many diseases, its effective for early detection but also to monitor disease progression. There are four studies published recently showing that we can detect sub clinical progression with the Rabin, that’s actually missed with very important tests like OCT. you know, OCT is the most important I think contribution we’ve had in the last 5 decades in eye care, but it doesn’t do everything. We see a lot of patients that actually have normal OCT’s and still have abnormalities in the Rabin test, which is interesting.
So, for neurological disorders, for sub clinical dry AMD, we’ll show you one of those, so the whole series of conditions, where we’re getting additional information from the Rabin Cone. This is a study that Duke published this year and intermediate AMD, as you can see over the right, over a period of 12 months the Rabin actually got worse. So, this patient progressed in a 12-month period and it’s a statistically significant change, however other procedures like OCT actually missed the progression.
In some cases, we’re actually seeing abnormalities with this test that we’re missing on some of the other tests that we know are very powerful as well.
Here is a simple case of diabetes of interest – Dr. Clarks presentation was great by the way, on diabetes, but here is a wife and husband, both have diabetes, neither of them have retinopathy, neither of the two have macular changes on the OCT but yet one has fairly dramatic abnormalities on the Rabin and the other one doesn’t.
See, these are the kinds of patients we get concerned about and we want to follow more carefully, so really making a sub clinical and pre-clinical diagnosis in this instance, of a retinopathy.
This is a study that I’m particularly interested in out of Mexico, looking at treating patients with a retinal dystrophy like retinitis pigmentosa, and this is with an injection of a new mild cure and of interest, these patients actually – as you can see those dark bars, improve significantly on the Rabin and the controllers didn’t really improve significantly. So, we’re seeing major changers, improvement with vision if you will with this injection in patients with diseases like retinitis pigmentosa. And these patients had no change in visual acuity, no change in contrast sensitivity, but a definite change in the color contrast test, the Rabin test. So, this will be helpful for a lot of drug studies. And these patients didn’t change in OCT, I wouldn’t expect the OCT to change in these retinal degenerations as well, it’s not going to get better.
Sub clinical detection of Plaquenil changes, lots of patients have conditions like Lupus or erythematosus, we’re very concerned about Plaquenil toxicity. The standard procedures for Plaquenil toxicity are relatively well known, here is a specific patient with no symptoms. 20-20 acuity, normal OCT, normal pattern ERG but amazingly a very abnormal Rabin. So, the color contrast test was abnormal, even though the three that we typically use to make a determination of Plaquenil toxicity was still normal.
Here is a former student of mine, one of my favorite students. We do this test on every third-year student, so out of 99 she was the only one who had dramatically abnormal results. So, 25 years of age, no symptoms, normal visual acuity, her OCT was completely normal, [inaudible 01:51:24] and photo receptors, and yet her Rabin was completely abnormal in both eyes and reproducible. Didn’t really understand this, I couldn’t explain it, two years later after she graduated she came to me and she said, let me give you some additional information – she said, you know, I used to play a lot of soccer and I’ve had multiple concussions, so her reduction in color contrast is probably due to multiple concussions which we have a history of, but nothing showed up on any of the other procedures.
Subclinical detection of patients who have blurred – a lot of patients complain about blur and yes, the Rabin is going to be abnormal for the vast majority of cases, it’s not going to give us a specific diagnosis, but it will tell us – it gives us more information to follow patients over time.
So, the Rabin Cone in your medical optometric practice is very useful for disease management, for diagnosis, certainly diabetes is as big as we’ve heard about today, that’s important and the Rabin is very useful there. Also, at risk screening for patients for let’s say – Plaquenil toxicity or you can actually use it as a wellness procedure. Just doing it on everybody. It only takes about 4 minutes and I find it particularly useful.
So, the benefits, multiple benefits are shown here, falling into five categories, lots of optometrists and ophthalmologists who are using it clinically find it very useful and do it on lots and lots of their patients. Some people are doing it on everybody.
Thank you.
Edward Chu:
Okay if you want to learn more about Rabin Cone and their systems, they’re going to be at booth 1719 and our final presentation of today is reserved for another one of our American academy of optometry ezzel fellows. Dr. Laura Pardon, from the university of Houston, college of optometry is going to be presenting on intraday repeatability of optic nerve OCT parameters.
Dr. Laura Pardon:
Good morning. So later today at the glaucoma super session I’ll be presenting my research looking at repeatability of optic nerve OCT parameters. So, glaucoma is a disease that effects the optic nerve and can lead to irreversible vision loss and blindness and right now glaucoma effects approximately 2.7 million people in the united states. This number is projected to increase to 4.2 million by 2030.
Major risk factors for glaucoma include age and inter ocular pressure and diagnosis of glaucoma is often based on – considering patient risk factors and also different clinical characteristics such as structure of the optic nerve.
We know however that biological measures tend to exhibit variations throughout the day. So, for example, normal variation in inter ocular pressure is about 3-4 millimeters of mercury throughout the day. In fact, inter ocular pressure can include structures such as the optic nerve head and so it’s important to understand changes in optic nerve head structures throughout the day if we are to differentiate normal individuals from those who have the disease.
So, in my research we optical coherence tomography or OCT to quantify these parameters.
The purpose of the study that I will be sharing today is to determine repeatability of different optic nerve OCT parameters under two conditions – so the first is, within a single scan session, so this is for two scans that are acquired at the same time of day. The time of day was randomly selected from the times listed on the slide, ranging from 7am to 7pm.
And the second condition we wanted to see what the repeatability was like over a 12-hour period, for this we compared scans obtained at 7 am compared with 7pm.
So, in our study we quantified four different OCT parameters. Two of them were obtained from radio scans, such as the one shown here, so – this image here is basically just a cross section through the optic nerve that was obtained where that red line is, and from these radio scans we quantified two parameters, the first is called BMO height, which is essentially a measure of the anterior, posterior position of the Bruch’s membrane opening. Our Bruch’s membrane opening is shown by these yellow circles.
So, BMO height is shown here by this red line and it is the minimum distance from Bruch’s membrane opening to a four-millimeter Bruch’s membrane reference plain centered on the optic nerve head.
The second parameter that we quantified from these radio scans is minimum rim width which is the measurement of the nuero-retinal rim thickness.
Minimum rim width is defined as the minimum distance from Bruch’s membrane opening to the innermost boundary of the retina.
Minimum rim width is a particularly importantly parameter, it’s been shown to change early in glaucoma, so we are particularly interested in seeing the repeatability of this parameter throughout the day.
We also used circular scans around the optic nerve to quantify two additional parameters. The first was retinal nerve fiber layer thickness, which is the thickness of a retinal layer that contains retinal ganglions or axons, so that’s this layer here shown between the red and green lines and the second parameter we quantified from our circular scans was Choroid thickness, which is the thickness of the vascular layer below the retina and that’s show right here between Bruch’s membrane and the outermost boundary here.
So, in our study we included 10 healthy human subjects. Mean age was about 29 and a half years old and we found that in our subjects there was actually considerable decrease in minimum rim width throughout the day and so this difference is shown here, it’s about 11 microns, we did not see changes in other parameters like we did with this minimum rim width. So, we found inter session repeatability for minimum rim width was actually very good with a mean difference of only about -1.5 microns, however when we looked at 7am versus 7 pm, the mean difference was -12.2 microns and had a greater standard of deviation as well.
When we looked at the other three parameters that we quantified we did not see much worse measures, for 12 hours versus the same session.
So, in conclusion we know from other studies that minimum rim width is a sensitive measure for detecting early stages of glaucoma. There is great intraday, so a greater variability over 12 hours for minimum rim width compared to the other OCT parameters that we investigated and the reduced inter session or same time of day minimum rim width variability suggest that when we monitor disease, it may be worth obtaining OCT scans at approximately the same time of day, however we still need to do future studies to look at whether the minimum rim width changes similarly on different days.
The reason that we’re seeing this change in minimum rim width throughout the day remains unknown, however it may have implications for glaucoma path and physiology.
So, thank you, if you’d like to learn more, I’ll be presenting today at the glaucoma super session at 2 pm. Thank you.
Edward Chu:
All right, so lot of exciting presentations, that was the last one, so this concludes the academy 2019 Orlando and third world congress of optometry press conference, first off on behalf of the communications committee I want to thank all the press for being here, obviously there is no press conference without the press, you guys are integral to our profession so we’re grateful for your attendance today. This room will be available until 10 am for your use and a lot of the speakers hung around, so if you have any questions for them please feel free to approach them. If you have any feedback from today’s event, please email me and we’ll be happy to correspond with you.
Next, I want to thank all the presenters that are still here for condensing years of research and hard work into 5 minutes, I can’t imagine how difficult that is, but we are all appreciative that you were able to summarize your hard work for us in that limited amount of time.
On the final product of the press conference is a lot of information in a short amount of time but for everyone in attendance we think we provided you with what we considered to be the best of the best in optometry in this past year.
The 10 scientific posters and papers were chosen from hundreds of abstracts and the scientific program committee sent the communications committee about 35 and then we narrowed it down to the 10 that you saw today. Similarly, we had about 25 – 30 companies submit applications to present today and once again we have to narrow that down to 10. It’s a very difficult task, I would not wish any of you to have to partake in it and I’m very grateful for the communications committees help in helping us select what you listened to today.
So, thank you again for being here this morning, we hope you enjoyed the last 2 hours, and hope you enjoy the rest of the conference here in Orlando and hope to see you next year in Nashville. Thank you.
