TOPIC:

After my appalling outcome from Optical Express' MPlus lenses, I wrote to Oculentis to enquire why my vision was so much poorer than OE had informed me it would be post surgery; extremely blurred vision, all the light disturbances and vision equal to looking through a 30 year old dirty shed window.
Interestingly they wrote back to say how good the MPlus lenses were/are and the need for lens explantation was unusual, however the rate they quoted for this was higher than OE quoted me (post surgery).

During my many months off work post surgery, due to said surgery (failure) I spent hours researching and said to OE's Steven Hannan that I have found out that if you have had multifocal IOL implants you cannot hold a flying license. I told him whilst I don't intend to hold a flying license, pilots are not the only profession who require a good level of vision, he told me my information was incorrect.

I beg to differ, "Multifocal IOLs are not acceptable":
www.caa.co.uk/default.aspx/default.aspx?...etype=90&pageid=9245

Hi again,

Just a little update, I was with one of the best gas permeable contact lens practices in London if not the world from 1994 through till September this year where now living in Germany and 3.75 years post Oculentis Mplus 1.5 implants and 2.75 years post left capsulotomy and the right eye lasek I am now plugged into the specialists at Heidelberg trying to get the advanced Swiss sclerals to work as my London experts after one year were defeated by the distance between us. The sclerals are meant to bandage the corneas which have been measured as having a 0.5sec right eye tear-breakup time (TBUT) and 4s left. Anything below 6secs is regarded as severe. This is due to both sets of surgery and some dry eye before surgery after nearly 30 years of gas permeable lens wear starting in 1986. The thing is, despite having worn a variety of semi-scleral lenses for my -10/-11 myopia including near vision, middle vision, distance vision and multi-focal, when it came to the assessment in January 2012 at the Moorfields private clinic, the optometrist dismissed ideas of a monofocal implant as unsuitable even though of course, I cannot read nor use the computer without reading glasses thus defeating the object of the Occulentis multifocal. The only activity where having multifocal helps is packing my parachute between jumps. I should have had a monofocal in each eye set for driving so the contrast in reading would be excellent. The thing is I was not given any time to make up my mind at the assessment and relied on their expertise. As I was flying back to Spain where I lived, I said ok, go with these mplus lenses. The consequences were nearly 3 years without a job, living off savings. Seriously, I do not lie. These lenses should never be used in anyone unless very old and even then I doubt it. I could go on as my history is literally more than that you find on Wikipaedia.

sight conscious wrote: ...should Multifocal lenses be banned till a test is invented?

Interesting comments.

Should MFIOLs be banned completely? To be honest, probably not, but that said they are still taking a gamble. The NHS apparently do not deal with MFIOLs at all, and will only implant monofocals (Sasha will correct me if I'm wrong about this). Also in the US the regulatory agencies (FDA in this instance) are far more sceptical about new multifocal products. (As an aside, having had dealings with the US FTC in the past, whilst their system for regulation is not perfect it seems considerably better than ours). There is still a significant chance that a patient in their 70s or 80s with advanced cataracts would still have a better outcome with monofocals and glasses than with multifocals. What percentage chance is this? As I think I've pointed out, no-one actually knows.

The CE mark issue is an interesting example of the lack of transparency within the industry. Have the Notified Bodies in Germany taken care to ensure the lens is safe to implant? I have every confidence that they have. Have they taken the necessary steps to ensure the lens is effective with a particular range of patients, and what is that particular range of patients (you wouldn't implant these in a myopic teenager, right?) Don't know. As a UK citizen making the request the Notified Body is not required to even acknowledge receipt of my emails.

Regulation is a surgical issue, and having seen recents posts from Sasha here I am both stunned and flabbergasted that surgeons within the industry are apparently not required to adhere to the Royal College of Ophthalmologists guidelines. So... Whose guidelines are they required to adhere to then? And who has the ultimate responsibility for defining what category of patient is acceptable for multifocal lenses?

In my case the decision as to whether I was suitable for surgery was made by an optometrist, not an ophthalmic surgeon. My surgeon did not meet me until 10 minutes prior to surgery and even then did not examine me except to rubber stamp my consent form and check my eyes were sufficiently dilated. He didn't know me from the guy next door.

As to market forces though; the medical industry does not behave in exactly the same way as other markets. It's true that market forces apply, but because of the high level of concealment within the industry (look at recent newspaper articles on disclosure of clinical trials) (and in fairness the usually cautious rate of development of new products) (I have pharma clients) those market effects appear more slowly. But no, you can't rely on market forces for regulation in medicine.

Been on this site for a while. A few comments. Would welcome your opinions.

1. if there are no real reliable tests to demonstrate vision after Multifocal surgery patients, should Multifocal lenses be banned till a test is invented?
2. Can the UK do anything unilaterally because if Europe licenses these lenses can we prevent its sale and use
3. What regulations, more than are currently in place, would make a real difference - reliably.
4. Can those regulations be applicable to all prostheses. Remember the PIP Breast implants had the CE mark.

Ultimately, if any technology is so faulty so as to affect a 'majority' of patients negatively, would it not have been abandoned already due to market forces when people would just not opt for it.

Anon wrote: In the interests of disclosure:
1) I am in the business of ophthalmology and refractive surgery... You would not have been in this position if it had not been for BUPA. The Financial ombudsman does not understand this issue of medical responsibility, however if you challenge the Ombudsman and ask them whether BUPA are appropriately qualified medically to redirect, they will have to ask for an expert or a body like the GMC or BMA to comment… As BUPA redirected you, from an ophthalmologist recommended by your GP then perhaps they are liable for your less than ideal outcome. I would therefore include them in your legal action...

Hi Anon,

I didn't see your comment until a moment ago. Thank you for the disclosure and the advice.

As an ophthalmic surgeon who operates outside of the BUPA production line I am assuming that if an individual who said they were a designer, had excellent (really excellent) distance vision with RGP lenses, very early stage cataracts and presbyopia came to you, you would probably be inclined to tell them to go away?

On this site Sasha Rodoy highlighted Barbara Windsor's situation. Clearly she was a candidate for refractive surgery. Selling it like fitting a pair of contact lenses is another matter.

Your points about BUPA are all well made I think, except for one. I don't think I have a cat in hell's chance of suing BUPA. They can put their hands up and say 'we're just insurance brokers' and back away from the fact they are making decisions that affect patients. They are simply too rich, too powerful and too distanced.

Which is why it might be fun to try

However: the structure and responsibility of the various organisations and colleges involved here is obfuscated and deliberately confused. This is why I completely agree with Sasha and John McDonnell, that the industry needs regulation which is fit for purpose.

'Al ', your comments are making my stomach turn. I am one of many victims of RLE whose lives have been ruined, you have no idea what you are talking about because if you sat with me and heard what the RLE procedure has done to me and my life, and dozens like myself, you would be never ever trivialise this procedure.

I am making a point to ignore your comments as you too have lowered your self to the level of the corrupted OE sales people, perhaps you are one of them.

Hi Al,

Al Faretta wrote: I am sceptical of some of the hype and it's best to have lower expectations to avoid disappointment. That’s what everyone tells me.

I suspect unfortunately that you may not be sceptical enough. Lowering your expectations is one thing; yes, these lenses are simply not very good. They try to shoe-horn an inferior optical technology - multiple overlapping images - into a system that has evolved to work with a single, varying focus image. Even that is not the problem though.

You can take all of your research, all of your due-diligence, and chuck it, because at the end of the day there is simply no way of knowing whether your brain has the necessary neuro-plasticity to adapt to multi-focal lenses. You cannot know in advance of surgery, and neither can your surgeon. That is why I say this technique is still experimental.

It is experimental because the underlying science of neuro-adaptation is not fully understood, but far more important than that, it is experimental because that science cannot be quantified. What is the mechanism that predicts a positive outcome? There isn't one. Who can predict whether patient X will be able to adapt and patient Y will not? No-one.

I do wonder if, with a less pressurised environment (i.e. a properly managed surgical practise, not a meat market) some greater degree of assessment might be given to the patient (other than a forty minute session with someone who isn't a surgeon). Perhaps prospective multi-focal lens patients should be required to wear multifocal contact lenses for three months prior to surgery. Maybe then they would find out if they are capable of adapting.

Perhaps also they should be shown visual representations of the potential outcomes of MFIOLs (halo's, fringing, double vision etc.) Or better still, perhaps they should be given tinted glasses with diffraction gratings to simulate the effects of driving at night.

But most importantly, perhaps somebody should actually pay attention to the individual and treat them as something other than a cross between a guinea pig and a MASH patient.

Shall respond in further detail soon and in due course, 'admin', but I am using an iPad Air just now and as I always do. I am lying in bed and it is 11.30 pm. I do not know much about IP Addresses but could you perhaps send me the various IP Addresses and I shall enquirer of Apple Technicals to seek an explanation.
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admin: Your IP address for this post is in Worcestershire. If you'd like to email me I'm happy to discuss with you. Confidentiality guaranteed re your name and contact details 'Al'...

Al Faretta wrote: I am a potential Multifocal lens patient as is my wife who has an early cataract… my wife has to have her eyes sorted by early next year if she wants to continue to drive.

Obviously I have read all your posts, including the ones I didn’t approve because of your blatant and irresponsible promotion of unnecessary surgery, advising people to go ahead and take the risk regardless of the consequences.

I am not going to say too much as I’m sure other people will respond to your post, but I would like to point out that if your wife has a cataract preventing her from driving then she is entitled to an NHS operation.

My friend is 54 and had cataract surgery at Moorfields NHS hospital two months ago, he didn’t wait long for surgery and is very happy with the results.

Al Faretta wrote:
I was quoted silly money by the Moorfields Clinic but at the same time we don't want to compromise care in any way.

Many of the Moorfields NHS surgeons are also in private practice, some across the road at Moorfields Private, and although not Multifocals, your wife will get same expertise.

Regarding your own plans to undergo lens exchange, no mention of cataracts, I am surprised that having done so much research you would even consider this, let alone in a clinic where there "is a busy waiting room”.

Having spent so much time reading OERML you know that a busy waiting room cannot be compared to a busy restaurant!

There’re unlikely to be many people eating if the restaurant doesn’t serve good food, whereas I’ve been in OE’s busy waiting rooms on numerous occasions (before they banned me) when the majority of people were patients left with problems!

You’ve obviously invested a significant sum of money paying for consultations, saying, "It needs a lot of research to ensure we take the right decision and not subject ourselves to an 'experimental' procedure.”

Surely this contradicts your post on 3 December?

Al Faretta wrote: Multifocal vision technology cannot be considered 'experimental' any longer if it has been around for 10 to 15 years.

You’re unusual Al, because the first thing most people wanting treatment do when they find OERML is to ask me for advice, but you haven't, in fact you've been offering advice.

Btw, you might be interested to know that your varying IP addresses all coincidentally match the locations of Optical Express clinics.

Small world

I am a potential Multifocal lens patient as is my wife who has an early cataract. We have been researching this surgery for the last over one year as I have a prescription of +6.5 and my wife is -2 approx. I have seven friends and relatives who have had Multifocal lens surgery over the years since 2008 and we have been to five consultations - a Moorfields Private Consultant, an NHS consultant in private practise, Optical Express, Optegra and Optimax. We have gone through all the information and the Consent forms given by each clinic. I am keen to avoid glasses but did not do well on the Mono-vision trial. It needs a lot of research to ensure we take the right decision and not subject ourselves to an 'experimental' procedure.

I was quoted silly money by the Moorfields Clinic but at the same time we don't want to compromise care in any way. In general I would instinctively prefer a clinic with a busy waiting room for obvious reasons. Pretty much all clinics use the same pool of Multifocal lenses and the results of the surgery primarily hinge on that single factor. I am reconciled to some degradation of the quality of vision on using Multifocal lenses and they inevitably cause some glare, haloes and ghosting but the degree to which that can occur, I am told, is not definite as it is very individual and subjective.

So my search goes on for the moment but my wife has to have her eyes sorted by early next year if she wants to continue to drive. There is a profit motive in all Multifocal lens surgery as it is considered non essential and so not offered on the NHS. I am sceptical of some of the hype and it's best to have lower expectations to avoid disappointment. That’s what everyone tells me.