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TOPIC: Refractive Lens Exchange (RLE)

NHS repair service 01 Dec 2015 13:44 #91

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Fitted with MPlus X lenses in 2014, like so many others Mr Z was left with severe side effects and poor vision.

Last year an independent surgeon advised he should undergo an explant, but at approx £11,000 this does not come cheap! Hence why I advise anyone left with problems to pursue legal action, so they can at least afford to pay for reparative treatment if it's an option.

As I advise all damaged patients, Mr Z had asked his GP for a referral to an NHS eye specialist, and last week I accompanied him to a consultation at Moorfields Eye Hospital - not to be confused with Moorfields Private which is an exclusive wing for fee paying patients.

At least one hundred NHS patients were waiting to be seen by only four consultants, though time is saved with standard eye tests conducted by an optometrist, followed with an examination by an ophthalmologist who notes details for the consultant’s examination.

The examination area in the NHS clinic is divided into approximately a dozen, side by side, open cubicles, each partitioned off with glass dividers. One of the benefits of this layout is that each doctor is able to call on a colleague for another opinion if need be. In fact Mr Z was examined by not one but three ophthalmologists, two of them consultant surgeons.

I had met the named consultant looking after Mr Z when I attended a Grand rounds* last year, who I will refer to as Mr F.

NHS surgeons are not happy about offering explants to patients because, quite rightly, it should not be the NHS who have to bear the significant cost but the private providers responsible for causing the issues.

Mr F said something had to be done for Mr Z as he could not be expected to go on with the vision he has, but I was very surprised when he suggested the option of an explant provided by the NHS!

Mr F stressed that he would ensure Mr Z was fully informed of his options, and the accompanying risks before he agreed to further surgery.

Totally supportive of what I am doing, and critical of the high street industry, he added that it was obvious Mr Z had not been fully informed by OE and he would not let that happen to him again.

He advised Mr Z that there was no guarantee that retreatment would improve his vision, that it could make it worse. He said he therefore wanted two weeks to confer with colleagues and explore at length the possible benefits and risks of further surgery.

If an explant is agreed it will be at significant cost to the NHS, and once in writing this will set a precedent for countless more patients to follow suit.

Perhaps when Jeremy Hunt realises exactly how much this could cost the government he will start listening, instead of passing the buck to the CQC, GMC and RCOphth.

Money is what grabs people's attention - especially when they’re losing it :kiss:

*Grand rounds are an important teaching tool and ritual of medical education and inpatient care, consisting of presenting the medical problems and treatment of a particular patient to an audience consisting of doctors, residents and medical students.
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Multifocal lenses and why you shouldn't. 01 Dec 2015 09:25 #92

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I've just read this again:


www.simovision.be/en/producten/presbyopia-lentis-m-plus-t-3/

I'm trying to reconcile the difference between my experience and this description. "In particular reflections, image jumps and loss of contrast sensitivity... will be avoided. Glare effects and halos will be significantly reduced"

Like hell they will.

I can only assume that the comparison is made with the benchmark being an unacceptably low baseline. As in 'previous lenses were completely rubbish, these are marginally less so.' I think all implanting surgeons, at onset of presbyopia, should be required to undergo refractive lens replacements. What percentage of implanting surgeons favour MIOLs over reading glasses?

I also despise the fact that this is constantly referred to as an 'industry,' with all the profit-related connotations that brings. What this 'industry' needs is regulators with teeth, not the cosy old-boys (and girls) club that currently prevails.
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Multifocal lenses and why you shouldn't. 30 Nov 2015 22:53 #93

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Hi Carl,
You make excellent comments concerning the debilitating results of these lens. Nature perfected our vision over millennia yet greedy manufacturers and butchers employed by sociopath businessmen brainwash people to believe they have bettered the natural lens within the past 10-50 years!

OE and their ilk are nothing but evil. Unfortunately for those they have damaged I cannot imagine how they can get justice when the organisations such as RCOphth, GMC, CQC and MHRA all seem to be singing from hymn sheets written by the cowboy eye surgery industry.

Multifocal lenses and why you shouldn't. 30 Nov 2015 17:47 #94

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Al Farretta wrote: I wonder if there is any machine that can demonstrate Multifocal vision before surgery.

Yes, it's called Photoshop and it's been around for a quarter of a century. To not provide visual examples of artefacts caused by multi-focal lenses in my opinion goes beyond clinical negligence into the realms of sheer duplicity. It isn't hard to do. My standard consultancy fees apply.

Multi-Focal lenses are by your definition experimental, and it is simply outrageous that Optical Express is allowed to market them in any fashion which suggests they are not. Lentis M-Plus lenses need 'CAVEAT EMPTOR' stencilled over their packaging in large red letters.

The side-effects of these lenses are completely unforeseen. A case in point (me again). When I first had the lenses implanted my colour vision went to hell in a hand cart. As a designer this basically scared the living daylights out of me because if it had stayed as bad as it was it would have rendered me unemployable. The moon was purple. Trees were brown.

Luckily, for the most part my colour vision has returned to normal. Almost. There are a few bizarre anomalies which remain. I have become adept at covering up the embarrassment which they produce.

So should Multifocal lens technology be abandoned? No, only the practise of passing them off as anything other than a lab experiment. What is utterly reprehensible is that these things are sold in the same way as glasses or contact lenses. They are not the same thing.

This technology is not at a stage at which it can be implanted with predictable effects. The sheer scale of the gamble being taken by implanting surgeons is breathtaking.
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Multifocal lenses and why you shouldn't. 29 Nov 2015 06:55 #95

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Carl G wrote: Sure, they bend light the way they are supposed to. Whether your brain can cope with that is a totally different question.

Carl's narrative is illuminating and his quote above is the crux. Individual expectations and ability to adapt to Multifocal lenses are the key but that is any persons subjective ability. I wonder if there is any machine that can demonstrate Multifocal vision before surgery. If not then it probably has to be a case of trial and error, till one is invented. Should Multifocal Lens technology be abandoned? Would it be like throwing the baby out with the bath water! That's food for thought.

There are no pre sale trial runs with surgery. All of us would surely wish there were.

Multifocal lenses and why you shouldn't 26 Nov 2015 14:46 #96

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Carl, thank you for your informative posting, an interesting read.

Carl G wrote: And what really annoys me is that Optical Express knew what I did for a living before they carried on and implanted them.


That would be the same for all of us . They use sales teams to sell and pressure people into having life changing surgery, for many of us ruining our lives. It is purely about money and lining their pockets and when it all goes wrong they react like dodgy second hand car salesmen telling you everything is fine.
This company has no morals whatsoever.
However I believe it is finally starting to unravel for Optical Express.

Multifocal lenses and why you shouldn't. 26 Nov 2015 11:01 #97

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Hi. I’m a 54 years old bloke who works on computers for generally 9 hours a day doing CGI and computer animation for the most part. I had refractive lens replacements almost 3 years ago now. Prior to surgery I used rigid gas permeable contact lenses for distance and reading glasses for work. My near vision was getting worse (presbyopia) my distance vision was constant. However, my quality of vision was excellent. By that I mean with lenses everything looked crisp and clear. I had once been told that with my RGP’s my distance vision was good enough for the RAF. Not any more.

Today, my eyesight is atrocious. Everything lacks contrast. Faces are blurred, I have fringing on hard edges, haloes and arcs under lights, and I can’t see into shadows. I have to strain to see entrances in low light. Driving gets more than a little interesting around four o’clock, just after sunset and just before the streetlights come on. This is winter with Lentis M-Plus lenses. Summer is not that much better.

My reason for having refractive lens replacements was cataracts, or so I thought. I spoke to my doctor who referred me to an ophthalmic surgeon. BUPA, however, had other ideas. I was informed by them that they would not cover the full costs for this particular surgeon as their policies had changed, and instead, with a fairly hard sell, pushed me in the direction of Optical Express. Which is of course the point at which things started to go horribly wrong.

It’s a subtle point but with 20-20 (sic) hindsight it turns out my initial examination at OE’s production line in Harley Street was to assess whether I was suitable for Lentis M-Plus lenses. It was not to assess whether they were suitable for me. In my opinion BUPA prevented me from getting the unbiased medical assessment which an independent ophthalmic surgeon would have provided and instead ushered me into the queue for these lenses.

The chances are that I did not actually need eye surgery, but now I will never know. I had cataracts, but my inability to focus at short distances was more likely to have been down to ordinary presbyopia than the cataracts. Once I was in that queue however, refractive eye surgery was presented as the only option.

In Sasha’s blog and on her forum I read many posts from people whose actual surgery went horrendously wrong. This is not the case with me, in the sense that my lens replacements are orientated correctly and have healed well. So what has gone wrong? There is, I think a simple answer.

Lentis M Plus lenses are not fit for purpose and should never be implanted into eyes.
It has taken a while but over the past couple of years I’ve ended up doing a fair bit of digging into the science of multi-focal lens replacements. To some of you reading this many of the things I’ve found out will seem completely obvious, but as Sheraz Daya pointed out when he gave a second opinion on my surgery, the level of education required to achieve what is referred to as ‘informed consent’ amongst patients is so extraordinarily high that it is nonsensical.

Refractive lens replacements (as you probably know) come in two flavours, mono-focal and multifocal. In the first case a fixed-focus lens is inserted into the eye to replace a natural lens that has become clouded by cataracts. This is they type of operation generally favoured by the NHS, they hold off replacing lenses until they really have to, most of the people who have mono-focal lenses end up happy with their distance vision because these lenses are uncomplicated pieces of glass in the same way as the lenses in ordinary prescription spectacles are. Patients need reading glasses but the optics are straightforward.

Multi-focal lenses though; they’re a different kettle of fish.

When you are young and your eyes are healthy you change focus by the muscles in your eye squeezing the lenses to change shape and so achieve different focal distances, from near to far. The lens accommodates. As you grow older the lenses harden and the muscles are no longer able to squeeze, and so conditions such as presbyopia, the inability to focus on nearby objects, occur. Multi-focal lenses try to get around that. In my experience, they fail.

Multi-focal intra-ocular lenses (IOL’s for short) work by presenting two images to the eye, one of near focus and one of distance. The theory is that the brain should be able to adapt to pick the correct image for any given distance. There are (at least) two problems with that.

First are the optical compromises. The analogy I’ve used (and have heard used independently by other people) is that going from natural lenses to IOLs is like going from a top of the line SLR camera to a throwaway Kodak Instamatic. The quality of vision produced by the lenses is atrocious. Loss of contrast, loss of ability to see into shaded areas, soft focus, fringing – the list of failures goes on and on. To be clear, the lens manufacturer – Oculentis of Germany – need to make these compromises because plain old physics dictates they have to. Representing these lenses as life-style substitutes for people with vision problems (go and look at the images they use on their website) is in my opinion utterly reprehensible.

There’s a second problem too, but this seems to me at least to be more complicated. That process of your muscles squeezing the lens to make it accommodate is a natural process. That has been evolved over millions of years. This process of projecting multiple images onto the back of the eye requires instead that the brain has to accommodate, which is completely unnatural. Your little grey cells have never had to do that before. Can they do that? Maybe. Can yours do that? Nobody knows.
The way in which the brain interprets images is still not fully understood by science, not in any exact way. No-one can take an fMRI scan of your brain, count up the number of neurons or whatever and say: yes, this person is going to be able to adapt to IOL’s, or this person isn’t. That evaluation is beyond the state of the art. So to be really clear, when Optical Express slice your eye open, scoop out your natural lenses with a fine scalpel and a jet of water and stick these bits of Perspex in, they can have no idea whether you are going to be able to adapt to them or not. Because it is impossible to know.

So who lets these people make the claim that these lenses are of a merchandisable quality? And merchandisable to whom? I struggled for a while to find this out (I should probably have just asked Sasha). I wanted to know two things; who said the lenses were safe to stick in your eye (they probably are, apart from the disquieting feeling of being able to constantly sense these foreign objects inside your eye. They feel hard and inflexible and I admit, once or twice in the middle of the night I have woken up with the irrational urge to stick my fingers in my eyes and rip the goddamned things out. They’re probably safe though). And who said that this technology was good enough in the first place, and for whom?

I went around the houses for a while trying to find out who is responsible for approving these lenses. I wanted to see the peer-reviewed papers published in recognised medical journals that gave the exact findings from independent researchers that substantiated the outlandish claims made by the manufacturers. High definition vision, my eye. I contacted my MP, Dominic Raab, who made enquiries. He wrote to the Department of Health and received an acknowledgement from the minister, who in turn passed the request to the Parliamentary Under Secretary of State for Life Sciences. Who gave me an answer. Sort of.

The responsibility lies technically with the Medicines and Healthcare Products Regulatory Agency (MHRA). Sort of. In fact the actual answer is that the MHRA administrates the issuing of CE marks of conformity in the United Kingdom. Specifically:

A multifocal intraocular lens is a medical device and so cannot be marketed in Europe without carrying a CE mark of conformity. A CE mark is applied by the manufacturer in accordance with the safety, quality and performance requirements of the EC Medical Devices Directive 93/42/EC.’
That wasn’t really my question though. Nightmares notwithstanding, I do in fact suspect the devices are safe (my eyeballs haven’t burst yet). It’s whether they’re any good that I wanted to find out about (I know they are not).

I made a Freedom of Information request to the MHRA. They responded quickly and efficiently (actually, full marks). The only problem was that their response told me little of substance. Because in fact they did not oversee approval of these lenses. They were approved under the CE mark scheme by a ‘notified body’ based in Germany, LGA INTERCERT, who worked in conjunction with the manufacturers to ensure the lenses were safety compliant. The question I asked:

I would like to request copies of documents supporting the assignment of a CE mark of conformity to the Oculentis M-Plus multifocal intraocular lens.’

The response: ‘The MHRA do not hold this information. This is held by the notified body/manufacturer.

To quote the MHRA: ‘The manufacturer can choose any notified body within the EU to CE mark the device. Once CE marked the device can be sold throughout the EU.

Well, I guess as a manufacturer you would want to deal with a notified body that was local. That seems reasonable. It didn’t answer any of my questions though. I tried:

‘I think what I am trying to understand is whether the notified body would have made any stipulations as to whether the lens was appropriate for any given patient. Would you, for example, offer lens replacement therapy to a myopic teenager? I suspect not. But would the manufacturer or notified body consider it permissible to give the lens to a patient in their early 50’s leading an active life whose distance vision with rigid gas permeable lenses is better than 20/20?
In addition, as a UK citizen am I able to make an equivalent request for information from a German company?

If you were able to give any insight as to the qualitative, as well as the quantitative, criteria that are set in these matters it would be very helpful and very much appreciate
d.’

Again, I received a prompt response:

A notified body is responsible for ensuring a manufacturer is conforming to the requirements of the medical device regulations. The clinical use of the device is the responsibility of the implanting surgeon based on the instructions for use, any additional guidance provided by the manufacturer and on the clinicians own professional judgement prior to implantation.

If you are not happy with your lenses I would suggest that you speak directly with your implanting surgeon.

You ask about the German Notified Body but I am not aware that they will be able to provide you with any information as they do not have an similar FOI scheme in Germany
.’

I tried contacting LGA INTERCERT. They have not responded.

So what do I make of this? Well, they’re just my conclusions but:

• The approval process for these medical devices is obfuscated. The general public is in practice not able to examine or question it.

• The science behind the lenses is questionable. Sure, they bend light the way they are supposed to. Whether your brain can cope with that is a totally different question.

• The quality of optics is sub-optimal. (This is me being very, very polite and not littering Sasha’s forum with expletives).
• The claims made by Oculentis and Optical Express and the way the lenses are presented, down to the happy-smiley advertising images of people, are excessive. Actually I haven’t contacted the ASA yet. Next call I think.

• This industry is not effectively regulated. The regulation process is a series of ineffectual links in a chain; there is no over-arching authority that ensures these lenses are fit for purpose.

• These lenses are not fit for purpose.

I’m suing Optical Express and my surgeon because there is no way I should have been given these lenses. I was lied to (and omissions are lies too). The quality of vision resulting from these lenses, frankly, sucks. And what really annoys me is that Optical Express knew what I did for a living before they carried on and implanted them.

Here’s a suggestion in case you are thinking of having multifocal lens replacements.

Don’t.
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Refractive Lens Exchange (RLE) 24 Nov 2015 20:57 #98

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Hi Julie ,

Sorry to hear that you have problems. I also had RLE in 2012 by the same surgeon you mention Dimitri Kazakos, and when I went back to him he just said “I told you there was a trade off” - he didn't or I would have run a mile!

You will find him extremely arrogant. My advice would be do not let him or anyone else there touch your eyes again.

Also if you have any dealings with Stephen Hannan I would advise you to record the conversations, not that it matters as he told blatant lies to me in letters he sent.

You are dealing with people who will go to any length to get rid of you and keep their money machine rolling.

Refractive Lens Exchange (RLE) 24 Nov 2015 19:20 #99

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Hi Julie

Don't let them anywhere near your eyes. I had RLE in 2012 and have all the same problems but they're not as bad as some, mainly because I found this site and Sasha warned me against Yag surgery so I cut all ties with OE. I am at present in litigation with them in the hope I can get enough money to sort out problems privately.

Good luck

Hazel xx

Refractive Lens Exchange (RLE) 20 Nov 2015 09:25 #100

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Hi I had my lens replacement done in 2011. I am shocked and sad because I have the same problems people have described here. Now my right eyelid is very heavy and left eye very blurring. I went to the clinic and they said I need Yag surgery and asked me to pay another £395 towards it. I had paid £4600 in 2011 to do the surgery but they insist I have to pay again this time!!

I don't know what to do, also the surgeon would be Dimitri Kazakos and I read a lot of people complained about him!

What a disaster they put us in!

OERML & My Beautiful Eyes Foundation rely on your support to expose the horrors of this unregulated industry.

Your help is very much appreciated!

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