UK Keratoconus Self-Help and Support Association

Hi

Not sure if people are aware of comments about this in the Announcements section. I would just like to say that this is a very important consultation, as this is not simply NICE saying whether CXL will be on the NHS or not. In fact, the outline suggests it not be widely accepted as a mainstream procedure....

1. Provisional recommendations

1.1 Current evidence on the safety and efficacy of photochemical corneal collagen cross-linkage using riboflavin and ultraviolet A (UVA) for keratoconus is inadequate in quantity and quality. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

Also
1.5 NICE encourages further research into photochemical corneal collagen cross-linkage using riboflavin and UVA for keratoconus. Research should take the form of studies that allow comparison with the natural history of the disease, and should define patient selection criteria based on estimated risk of disease progression. Outcomes should include measurement of visual acuity, topographic assessment of corneal stability, prevention of progression to transplant, and long-term safety. NICE may review the procedure on publication of further evidence.

I have emphasised the fact they are suggesting research is conducted in comparison with the natural history of the disease (when actually it is a condition, but lets not split too many hairs!!). This means that some people may end up not having CXL even if your hospital starts doing it, as, if they were doing it on a research basis, they would assign people randomly to be in the CXL/Non CXL group. I understand that In John Hopkins in the US, such is the ethical worry about leaving people untreated, they are offering those put in the Non "true" CXL group (i.e. "fake UV" is used in the procedure) a proper CXL procedure after 3 months.I doubt that would happen here.

I do urge people not to be complacent about this. Often the NICE guidelines have a huge impact on the way a condition/disease is treated overall in the NHS. The recent guidelines on glaucoma has had an immense effect on how people are referred to hospital and monitored. They can only work with what they are given in terms of consultation and it is important for those who have HAD CXL in the UK to offer their views based on their experience.

Therefore I am opening a debate here on the guidelines as I wish to make a submission to NICE and would appreciate all input.

First thing though.... in the overview, keratoconus is described thus:

Diagnosis of keratoconus is based on corneal thinning and scarring at the apex of the corneal cone, found on slit-lamp examination.

As scarring is an exclusion factor in most studies of CXL, this is more or less saying by the time you are officially diagnosed, you can't have CXL. It is this sort of factual inconsistency the consultation is designed to weed out.

So, if you have not had a look at the documents yet, I do urge you to http://www.nice.org.uk/ip724 and do join in this debate!

Lynn

Lynn

Lynn I'm glad you're making a submission to NICE this needs to be done as they are not greater on user involvement although the KC Group could register as a 'stakeholder' and get representation on the guideline development group if it's still meeting or meets further for revisions.

I feel it moraly wrong to ask a consultant to play God so to speak. In my opinion if you know there is a 50/50 chance of having CXL and there is no way youd know until the KC got worse, who is going to take this offer up on the NHS?

Certainly not me, I'd bite the bullet and go private and know I've had the full treatment. Now is the time for us to have our say so CXL is performed properly and freely available early on in our treatment and proper acceptance criteria regarding what is deemed a success.

We have the chance to influece these people to avoid the problems we have with grafts. All to often it has been reported on this forum that the consultants are only concerned about there being no rejection and the cornea is nice and clear. The fact that the vision is worse than before the op and contact lens fitting is more of a nightmare is no concern to them, that is for the the patient and contact lens fitter to fix.

You don't have to have had CXL to give your response to the consultation and we only have until the end of the month which is disgraceful as it gives no time for any support group to get the information out to everyone, only those on this forum which to be honest despite alarge registration only a few users are active. There is a similar number on the news letter mailing list who are probably completly unaware of this consultation. Another factor NICE should be considering putting right. Ok it might delay the decision process but at least all the interested parties have achance to make comment. Plus are these guys in beach of the Disability Discrimination Act, no where on there site could I find how someone that is visualy impaired could download a large print version of the document. Much of the document is font size 10 or below!

with regards the the non-active forum members not being aware, would it be possible for one of the adminstrators/moderators to do a groupwide PM, therefore generating emails to those who dont use the site to make them aware in a short time frame about the consultation?

1 I am pretty sure that it would be possible to devise a less impressionistic definition of keratoconus, and also on that is less exclusive.

2 I agree with Gareth about the ethics of this sort of testing, but the truth is that to be effective even the consultant should be unaware of whether (s)he is delivering real or control CXL. Weird as it may seem, this standard of testing may be the only way we can be sure that any effect that is identified is real.

All the best

Andrew

Consider this:

Is CXL a surgical treatemnt for KC or medication for KC?

Consider the removal of an appendix which is surgery, you wouldn't operate on the patient and leave the appendix in just to see if putting the patient through the process with no further treatment to see fi that helped would you?

The risk we run here is that someone with a corneal thickness approaching the 400 micron limit is randomly selected to have the placebo. Then during follow up the condition has progressed and they are at or below the 400 micron corneal thickness would then be denied CXL and probably intacs too.

How many patients would sign up to that?

No argument there, Gareth, but consider this: CXL is not surgery and not medicine, it is a treatment or therapy for a condition that is known not to show any pronounced progression in the majority of people who show early signs of being affected.

Treat 100 people with early stage KC. It is estimated that if nothing had happened, 80 would have needed no treatment at all. But, which 80?

The only way to assess whether there is any consequential benefit is to run the blind trials. My own guess is that if there had been a proper evaluation of this new therapy some years ago, it would now be available on the NHS. Instead of being subject to a proper evaluation the therapy was made available at considerable cost so that a heap of useless data was produced; this has served only to muddy the waters.

Andrew

Thing is guys, NICE are not actually interested in service users views which is why the consultation periods are short. Service users have reported bad experiences on many of their guideline development groups, I myself had appalling experiences on one such group, so much so that both myself and the other user representative ended up resigning after a few months, and we knew our stuff, took in all available evidence but unless it's a RCT, the "gold standard" of evidence, they aint interested.
So take whatever opportunies you can seize - but don't hold your breath, NICE is not nice.

In which case anyone in the trial must be monitored to ensure they have CXL as an option before the 400 micron limit is reached.

As Lynn put regarding a study in the US, those who showed signs of progression after 3 months were given the CXL.

MHRA cover the gidance on drug development, NICE decide if the drugs can be on the NHS and surgical procedures but who regultates therapies?

Drug developemnt is heavily regulated becasue of the effect it can have on lives, what is forgoten is that therapies and surgeries can be just as devastating if they go wrong so does regulation/monitoring need to be changed so when NICE consider therapies problems sucha s we are discussing are addressed early on in an ethical manner?

Andrew,

One issue I have is that the only studies quoted in the overview appear to be UK ones. I am assuming this as none of them go past the 3 year period and the Dresden study is over 8 years now. If you take evidence from studies world wide, you get a much better picture of CXL effectivity. In other words, how often do you have to reinvent the wheel before someone thinks.. hmm.. it actually WORKS!

With the EU encompassing so much of our lives and reducing sovereignty, it is frustrating that in the realm of medical research, we appear to cling to our nation state individuality.

There are precedents for abandoning strict scientific research - as far as I remember, aspirin trials were halted when it became obvious that the control group were dying at a faster rate than the aspirin taking group. I understand totally the reasoning behind scientific research - but Gareth is right, its not a question of science its a question of who would agree to the terms of the research? Those who want the treatment and can afford it, will pay. Those who can't afford it will submit themselves to the research lottery and to be honest, to gain useful data you will have to follow people up for YEARS. I imagine you will have more and more drop outs as people save up to afford the treatment. Thus your study group becomes less and less "scientific" as each year goes by, which taints the data.

Its a tough one...but to my mind, if you pool the data already collected world wide you will reach fairly clear conclusions as to efficacy. Long term side effects are going to take a long time to show up, for obvious reasons and are not within the scope of this consultation I don't think.

The problem also is: what do you do about post CXL vision correction? To test efficacy properly, you would have to have everyone not wear any contacts afterwards. Otherwise progression rates are subject to the vagaries of different contact lens types and the way each type is fitted.

Lots of food for thought!

Lynn