REFRACTIVE LENS EXCHANGE aka RLE/NLR +IOLs

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 appreciated.’

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.

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.

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

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!

In my opinion, the only reason why anyone should consider lens exchange


www.dailymail.co.uk/health/article-32876...sunglasses-wear.html

This is Ronnie, who came to Bad Eye Day lobby last week with his friend Dougie.



Ronnie and Dougie are both from Scotland, but sadly that’s not all they have in common...

In 2013, within three weeks of each other (unbeknown to them at the time) both men had refractive lens exchange (RLE/NLR), performed by Dr David Teenan in Glasgow.

Ronnie told the shocked BED audience how he lost vision in his right eye within weeks of surgery, and is now totally blind in that eye.

Ronnie and Dougie now have something else in common - the same lawyer

Al Faretta wrote: There shoul be information in peer reviewed journals, surely. Comparision of results is the only way one can get a perspective to take an educated informed decision.

That's a good idea, the Journal of Refractive Surgery for example.

Contributors to the July 2009 edition:
• David Moulsdale
• Steven C Schallhorn
• Jan A Venter
• Stephen J Hannan

David Moulsdale of course owns Optical Express, while the rest all work for him!

While 'iDesign' blanket advertisers Abbott (AMO) provide much of the hardware to OE.

Businessman David Moulsdale even wrote an introduction for this 'independent' medical journal:
www.healio.com/journals/jrs/2009-7-25-7-...f-refractive-surgery

Peer reviewed journals? As reliable as Trustpilot!







And Lorna made a very good point

Are any stats available for RLE problems in general and not only in High Street Clinics in the UK. What about in small private practitioner set-ups in the UK. Rest of the world. This surgery is being done widely in Europe and Asia. There shoul be information in peer reviewed journals, surely. Comparision of results is the only way one can get a perspective to take an educated informed decision.

admin: Deleted as blatant promo for Optimax

After 4 years intensive and extensive research, and daily communication with thousands of patients damaged by lens exchange and laser eye surgery, my findings suggest that problems are suffered by 40% of patients treated at high street clinics.

Coincidentally, a recent study in Japan supports my estimate: www.japantoday.com/category/national/vie...sks-of-lasik-surgery

And in China, a surgeon who pioneered lasik 20 years ago has said he will no longer perform the procedure after discovering patients have developed problems as a result long after surgery: www.chinapost.com.tw/taiwan/national/nat.../Surgery-pioneer.htm

There are no available statistics for the numbers of patients left with problems after lens replacement or laser surgery, not even the surgeons employed by the high street chains know many they’ve damaged in their wake.

Fact!

This is one of the points of My Beautiful Eyes campaign, which calls for the government to regulate the refractive eye surgery industry.

Lens replacement is cataract surgery, free on the NHS. The only difference is that companies such as Optical Express and Optegra sell this procedure as an option to using reading glasses, to people without cataracts, and offer multi focal lens instead of monofocal.

While this is a relatively new procedure compared to laser, the post op problems are frighteningly high. Google “MPlus X” for just one example.

Knowing as much as I now do, I do not condone or recommend elective eye surgery of any description for any reason other than it being the only option to going blind - because you really could go blind as result of lens replacement surgery!

This is contrary to Optical Express' legal claim against a newspaper who mentioned blindness in a story published earlier this year. (More on that to come people)

Stuart, I do not allow advertising on OERML, but if you send your number I will call you with more details so you’re able to make a fully informed decision.