Please could you give a brief introduction to age-related macular degeneration (AMD)?
AMD is the leading cause of vision loss in anyone over 50 and globally in 2010 it was estimated to cost $340 billion to treat AMD. The costs are set to spiral over the next 20 years and really over burden the healthcare system unless people start to take preventative action.
AMD is a type of sight loss where over time you slowly lose your central vision. So for example with advanced AMD, if you were looking at someone in the face you would not be able to see their face, you would only be able to see their hair. If someone was waving to you in the street, you would not be able see who they were. It is a very debilitating type of sight loss:
you can’t read
you can’t write
you can’t drive
you can’t watch TV
you can’t look at loved ones
People often become quite depressed with this type of sight loss and some commit suicide so the socioeconomic impact of AMD is very large.
AMD has been an emerging science over the last 10 years because the other type of sight loss, which is cataracts or glaucoma, is well known and have quite a mature and established type of science AMD is really starting to become quite prevalent and noticeable in society now, because so many people that get AMD tend to get it in the later years of life like in their 50’s, 60’s and 70’s. Up until now – when life expectancy was shorter than it currently is, many people died prior to being diagnosed, family histories were never identified, people with children wouldn’t have known that their parents had AMD and so would never have got tested themselves for AMD.
Now people are living an active lifestyle for an awful lot longer – such as in to their 80’s and 90’s – a lot more people are getting diagnosed with AMD and the debilitating effects of the disease are being felt. AMD as a science and as a body of clinical evidence is becoming established now and there has been an awful lot of work done around what causes AMD and we think there are a number of key risk factors.
The major factor thought to cause macular degeneration is high energy blue light from the sun. Prolonged exposure to the sun over time will degenerate the macula. What is the macula? The macula is made up of primarily two carotenoids that you take in through your diet called lutein and zeaxanthin. What they do is protect your retina which is at the back of your eye. Your retina is responsible for vision and it is made up of rods and cones – rods help you see in the night and cones help you see in the day.
The macular pigment shield has two main functions – it filters the harmful blue light so that it doesn’t hit the retina behind it and it scavenges for free radicals. So if you don’t have a lot of macular pigment a lot more blue light is hitting the retina and thus over time you lose your sight quicker than if you have a thick macular pigment.
There have been a lot of studies over the past 8-10 years on what exactly is macular pigment because about a decade ago nobody knew. Clinicians didn’t really know that it was important and helped to protect your sight. So there has been a lot of good quality science into understanding what it does and perhaps the biggest breakthrough is understanding that if you take lutein and zeaxanthin and you put them into a food supplement and you take that food supplement every single day then you can show that a patient’s macular pigment density, i.e. their shield - is denser, over 6 to 12 months.
What is fantastic is not only can you now show that supplementation is efficacious in increasing your macular pigment shield but it also allows people to improve their visual acuity and that is huge. That data is only starting to come out now, for example, Dr Ian Murray, who we work with on our device, has done a study which is about to be published where he took 40 patients who have dry AMD. He had a placebo group and he gave another group lutein over 12 months and at the end of twelve months showed a statistically significant increase in MPOD (macular pigment optical density) in the group taking lutein. This MPOD is what our device measures.
The lutein gorup all showed an MPOD increase and more importantly, when looking at the Snellen charts (the ones with big letters going down to small letters that you look at in an opticians) they could see further down the chart. This is in patients who already have AMD so it demonstrates that supplementation not only improves their macular shield but it actually halts/prevents/delays the AMD getting worse.
What is the difference between dry AMD and wet AMD?
Roughly 90% of the population get dry AMD and 10% get wet AMD. You have to go through dry AMD to get wet AMD. Dry AMD is where you slowly lose your sight but it is not entirely debilitating. What happens is if you do nothing about it and you don’t treat it, there is a time, and nobody quite knows when and how this is triggered, that the blood vessels at the back of your retina will burst through the RPE and you get what is called wet AMD which is bleeding at the back of the eye into the retina. You can wake up after having this happen and you’ve got really debilitating sight loss all of a sudden.
So what’s been happening over time is that government and management strategies have been taking patients with wet AMD, so not the 90% but the 10%, and they have been focussing on those patients and giving them 1 of 2 drugs called Lucentis or Avastin and they are injected into your eyeball which is incredibly painfully and intrusive. It may not always work. It is also incredibly expensive. Also, one of the side effects is death – so not a great treatment!
Doctors and people have been looking at this and have been thinking this is not a good management strategy. We shouldn’t just let people with dry AMD wait until they get wet AMD and treat them using this. What’s happened now is that all the emphasis has moved into looking at the 90% of people who have dry AMD in the first place and looking at how we can prevent them from getting wet AMD. That is where our device kicks in – a macular pigment screener to identify those at risk and ensuring a preventative management strategy is put in place.
Who is most at risk of AMD?
You can screen to find out which people are at risk of developing AMD before the age of 100 – because if we all live to 100 we will all have some form of macular degeneration as it is an age-related disease – after all we won’t have walked around with our eyes closed for 100 years!
If you’ve got blue eyes you’ve got less protection against the sun than brown eyes. Screening is about identifying and then preventing people from developing AMD, because we now know that if you screen someone that is found to be at risk you can now put them on supplements which are efficacious.
It has taken 10 years to get to this statement and it is being published in April 2013. It is a ten year study called AREDS 2. AREDS1 went from 2001-2006 and AREDS 2 went from 2008-2013. AREDS is an Age related eye disease study 2 by the National Eye Institute in America. It is a double blind placebo controlled study with around 5k patients. They have published their preliminary findings saying it has been a success and if you take a certain combination of lutein and zeaxanthin and other ingredients to help absorption etc. then not only does it increase your macular pigment shield it increases visual acuity and can delay AMD.
Eye care professionals all need to screen to prevent AMD because if we can measure people’s macular pigment baseline at the ages of 40 and above – not at 80 as it is too late then - you can inform people of the other risk factors for AMD. So, for example, if you are a smoker it has been clinically proved that smoking increases your risk by 50%. If you have a family history that also increases your risk – people only start to understand that now they are living longer.
The following factors may also increase your risk:
if you have blue eyes
if you have blonde hair
if you have fair skin
if you are female
if you have diabetes
if you have cardiovascular disease
if you are an outside worker who has prolonged exposure to the sun
Also, if you have a very poor diet, for example if you are always eating junk food and you are not taking in green leafy vegetables that contain lutein, oily fish and peppers that contain zeaxanthin, then you are not going to get them into your diet therefore you’ll never have a good macular pigment.
So there are risk factors that are obvious ones that you can do something about. The two main ones that carry the highest risk of AMD are low macular pigment which you can now boost and smoking. They are two that can instantly make a difference.
Can computer screens cause AMD?
That is an interesting question. It hasn’t been proved or disproved. Computer screens emit blue light that is for sure, but the blue light that comes from the sun is at 3000cd/m2 and the blue light that comes from computer screens is about 30cd/m2 and is not likely to be considered ‘hazardous’. In Asia they have a far more advanced understanding of the damage of blue light and opticians are selling yellow-tinted lenses to youngsters who do gaming conventions. It may be a PR gimmick to get them to sell more glasses but there is a concern and some sort of fear and uncertainty that prolonged exposure to screens may cause AMD.
Please can you describe the new macular pigment screener (MPS II) that has recently been launched by Elektron Technology?
The company that we bought, launched the original macular pigment screener called MPOD about 7 years ago. This re-launch is in answer to the issues that both patients and operators had with the original first-generation device which were primarily with the software that goes with the hardware.
The improvements are that over the last 6-7 years we are very proud to say that our macular pigment screener has amassed the largest normative database of any MP screener and so what that allows us to do now is to do away with the peripheral test. If you can imagine one of your eyes looking down into our eye piece and there are three lights in a row and you look at the centre light which flickers between green and blue and you have to press a button when you see the flicker. That measures an amount of blue light that is going into your eye that you can register and see. Then what you ask the patient to do is to look to the side where there is another dot. You get them to concentrate on that dot whilst at the side of their eye they see the flicker and press a button. So that is actually quite hard to do as your eye wants to return back to the centre but of course if you do that you negate the whole test. Also while you are staring at this small dot, it tends to bleach out. Then your eye starts blinking and gets a bit teary.
To cut a long story short the peripheral test was very subjective and very difficult to do and it gave noisy data. What we’ve been able to do in the last 7 years because we’ve got this large normative database is completely eradicate the need to do a peripheral test and just do the central test only which takes about a minute. This is because we’ve been able to substitute a person’s age for the result that would come out of the peripheral test.
This relates back to a paper that came out in the 1990’s that shows how every decade that we live the lenses in our eyes go a little bit yellower – and that amount can be quantified. We took the algorithm in that paper and we mapped it to the readings that we got for our 2009 study group of around 6k people and found a very tight correlation between the actual readings and the substituted age estimate. The Van Der Veen study was the first key study that came out using our macular pigment screener: http://www.ncbi.nlm.nih.gov/pubmed/19236582
So we now do not need to do the peripheral test as we can substitute age instead. The patient screening has gone down from about 12 minutes and it was quite uncomfortable for the patient to about 1 minute per eye where it is very easy and less demanding for them.
Are there any other benefits of MPS II and how does this screener differ from other macular pigment screeners on the market?
Our screener operates without the need to dilate the patient’s pupil. It is totally non-invasive for the patient.
Our instrument also is a very innovative take on an established technology. We use a methodology called HFP – heterochromatic flicker photometry – in other words click a button when you see a flicker. The original HFP technology involves the patient clicking the button when they don’t see the flicker. This is actually a lot harder to do because your eye plays tricks on you and you think you see a flicker when you don’t. So we turned it on its head and patented that approach. MPSll is therefore a lot easier for the patient to use and a lot more reliable and accurate in terms of the data generated.
In summary our device is undemanding for a patient to operate; it is a fun and easy test with no pupil dilation. Secondly, it is much easier for the operator as we have included an algorithm which takes away the onus on the operator to determine whether the graph is of a good quality or not, i.e. whether the data is noisy. I think this was a real issue with the first generation device, as operators struggled to determine whether graphs should be considered noisy or not. Basically now we just have a traffic light system, red green or amber for whether or not the data quality is good. You get an instant result, i.e. this is your macular pigment level and then for the operator you get a ‘yes you can save this graph it is good’ or ‘I would re-test this patient’.
How accurate is the new MPS II? How is this measured?
It is very accurate in terms of you will get the same reading if you measured your MP every day within +/- 0.04. It is much more reliable now you take peripheral out because peripheral is inherently too subjective and difficult to do so the data is noisy. So in terms of reliability it is far more reliable than it used to be. Again we are the only macular pigment screener that can do centre only because we have got the largest normative database to enable us to do away with peripheral testing. So it is very accurate, reliable and repeatable.
In 2011 a paper came out by Frank Eperjesi where he basically stated in the discussion section that our macular pigment screener had the best coefficient of reproducibility and reliability on the market.
Please can you outline how MPSII was developed?
We work with Dr Ian Murray and David Carden, who are both great thought leaders in macular degeneration. Dr Ian Murray is based in Manchester Eye Hospital. We work very close with them and are developing new technologies and new functionalities with both of them. It is very important to state that this isn’t just a device that has come from Elektron Technology, this is a device that has had 10 years of working with key opinion leaders in the industry and we will continue for another 10 years at least!
It is quite an exciting time for AMD as public and professionals are becoming aware of it. AMD Alliance have done a great job this year of creating public awareness. Lots of countries, particularly in Asia, are massively more advanced than us about AMD and the harmful effects of blue light. So they are very receptive to the machine and its value. What we are trying to do now is work with countries/institutions to develop their normative databases in their areas and then produce a lot of the clinical datae based on our device.
We have a lot of academic researchers using our device because you can get access to the raw data, which again is quite unique. People use it to do clinical studies because it is not a black box. You can pull out the underlying raw data, export it and start analysing it, which for a researcher is vital.
So the development of the device is on-going, but we are doing it alongside the originators of the device.
How do you think the future of macular pigment screening will develop?
I think that it will become standard – just like getting your cholesterol is now standard. Getting your cholesterol tested 5-10 years ago wasn’t even proposed, that was because you had no way of a) measuring it and b) seeing the effect of your actions thereafter. However, once you could measure it everybody started to get it tested.
Now you can measure your macular pigment and you can do something about it and improve it. That is compelling. What we want, and we are joining forces with other key stakeholders in order to do this, is to get everybody over the age of 40 to get their macular pigment screened just as they would with every other type of test when they go to their opticians. People need to understand what their baseline is and they need to take proactive steps, such as lifestyle choices and/or supplementation depending on how at risk they are to AMD.
I would see the future of macular pigment screening a lot more in the hands of the public. Our vision is to make MPS ll self-service, so you go into a booth in a pharmacy, you pay your money, you get your screening – because it is so easy to do – you can operate it yourself. Then you get a print out and you can walk down the aisle and buy your supplements.
I think that now the financial analysis has been done on how much it costs to date, it brings the burden of this disease into focus for many healthcare professionals.. The fact that as we speak in America there are 11 million adults with some form of advanced or early wet or dry AMD. That is huge and it is set to go to about 50 million by 2050 by some studies. If people don’t do anything about it and we all live longer then we are going to see an epidemiological explosion in AMD – particularly now that the Asian populations are adopting a Western lifestyle and diet. We have just gained a grant from the NHS with Dr Ian Murray to do another form of screening for AMD which is indicative of the increased emphasis the NHS now feels AMD needs to have. So I think that publicly and professionally this is something that we need to tackle head on through screening and prevention, now the science is becoming understood.
What are Elektron Technology’s plans for the future?
Well Elektron Technology’s Ophthalmic division is also working with Professor Henson who puts his name to the range of Henson Visual Field Perimeters we also make. Our teams have been working with him for 20 years developing perimeters that diagnose mainly glaucoma which is the other form of sight loss. Sight loss can either be central or peripheral. So now we have two types of devices that screen and analyse for both types of sight loss.
In terms of a plan for Ophthalmics we are working continuously with both Ian Murray on MPS II and Dave Henson on the Henson Perimeters. We want to update them and make them better and move them forward in line with people’s needs and expectations.
There is basically a five year road map that I have put in place for both the Henson perimeter and the MPS II. Elektron are focussing heavily on this area and we should hopefully see some really good growth internationally. Traditionally both brands have only been sold in the UK and the first generation MPOD was in the US too. My job is to improve them and then internationalise them and make them available across the globe. So I have been very busy trying to set up registrations in different countries and distributors etc.
Where can readers find more information?
About Jaquie Finn
Jaquie brings over 22 years of scientific and commercial experience to her role as Product Line Manager of Elektron Ophthalmic.
After gaining an Applied Biology Degree, she worked as a Molecular Biologist for a decade – including 4 years at Cambridge University.
She then moved into Bioinformatics in the dot.com era and trained as a Product Marketer and Product Manager for high end technology companies in Cambridge. She has a CIM Diploma in Marketing and currently specialises in New Product Development and business development.