Keracatonus Cross Linking C3-R® Help!

[GarethB]

CXL may have been around for about 11 years but that I think that is from when the first studies were done on people and in small numbers.

For me the true waiting time to see if a new treatment is really safe is when it has been freely available to all for 20 - 30 years or more. As far as I am aware, in the UK it has only been a couple of years where it has been freely available through private practice and as yet only available to those on the NHS who are taking place in clinical trials which have only been going for about 12 - 18 months for the ones I am aware of.

[pepepepe]

Intacs took five yearsr to be freely available on the NHS, CXL is done by NHS consultants and privately now as it is unethical to allow KC to progress.

And contact lenses are not a treatment, its just an optical aid. Again, as it was said, which treatment has there been where someone has to wait until someone had the treatment and then died of old age to have the same treatment ? Please list them.

[rosemary johnson]

pepe, no-one is denying that there are - apparently - potential benefits of doing CXL within the short-term time frames fro which data is yet available.
(It may also have been done on some people whose KC would never have progressed anyway, even without the CXL, so they have had the disruption and risk and discomfort for no benefit - but no-one will ever know for sure how many of them there are.)
SOme one asked about possible long-term side-effects - to which the answer is, no-one knows what long-term side effects there may be, because CXL has not been in existence for a long time yet.
It is possible that time will prove there are no long-term adverse effects of early CXL.
It is also possible that bad side effects will come to light and that there will be people now clamouring for CXL who will in future come to regret it.
I hope not, naturally, for their sake. Of course I do! I've had one eye operation that went disastrously wrong and I don't wish that on anyone.
No-one will ever know, of course, whether anyone's KC would have advanced significantly without the CXL or not.
Rosemary

[pepepepe]

The remit is if there is progression, this is through evidence that this is happening by checking at intervals, are you saying ophthalmologists are not giving the right advice ? What you say is so easy to say, where is the evidence if this is so, it needs a medical professional to make that judgment for an individual case in front of them, also it depends on the readings which corneas will improve with vision too, are you wanting to stop someone not get this benefit ?

Crosslinking should have been here in the UK years before it has been.

Your operation was corneal tissue replacement, its like comparing apples to oranges. If we look at Kerasoft, are there any studies to prove its safety, or how well it works ? and if not why are they getting marketed heavily ?

I was asking for the evidence of what was stated by another poster on this topic, none was given or any questions answered.

[GarethB]

For decades grafts have been regarded by many consultants as a cure but from experience I know KC can come back as it did with me in the host tissue nearly 20 years after the graft however it ise xceptionally rare. Since being part of this group I have asked many consultants how common this is and very few have seen a reoccurance.

CXL I am sure is beneficial but unless it puts the cornea back to it's original pre-deseased state it initself is far from a cure just another management startegy as is intacs, PK, contact lenses and so on.

Contact lenses are medical devices and there is different classifications of medical devices.

Low Risk Class I upto High Risk Class II.

I do not know where contact lenses would come in this classification.

and as such must comply with Medical Device Directive 93/42 EEC/MDD), additional legal requirments that will will have been considered are ISO13485, ISO14971 (Risk Management), ISO10993-X (Biocompatibility), ISO14155 Clinical Studies.

ISO10993-1 minimum requirments if there is skinn contact are cytoxoicity, sensitisation, irritation and depending on nature of contact, systemic toxicity, genotoxity, hemocompatability, chronic toxicity, carinogenicity. To gain a CE mark, everything in artickle 17 of the standard must be achieved.

Regarding kerasoft and how well it works, well that is patient dependant as it is not a fix all just like any other contact lens, it is just another lens that is more beneficial to some than others. Keraspoft has been out for many years and the original lens and the K2 use a material that has been around for decades. K3 is a silicone hydrogel material that has beena round for many years and is now probably the mainstream soft lens most people are familier with.

I would like to think the study I amtaking part in and I know a number of hospitals are trialling the K3 lens will help answer your questions but to get hospitals and private practice interested you have to market the product otherwise how else will you get these people interested so they can run independent trials?

[pepepepe]

Well on the Kerasoft site they should say what you just said and that they are at the trailing stage only.

Only god can cure, a transplant ain't a cure or anything else. Only CXL treats KC's progression - Every other "treatment" masks KC.

[lars]

I'm neither a doctor nor an expert but I think that when you see your KC quickly progresses and your vision deteriorates, you can't just wait 20 or 30 years until cxl is fully evaluated.

Noone knows how much his KC will progress ofcourse but I am sure opthalmologists have some statistics and are able to conclude whether cxl is effective or not for the short term at least. What I mean is that doctors know that 1/5 of kcers will need a graft and in what age this happens, it is relatively easy to compare this with the population of kcers who had cxl. KC may be individual but statistics never lie.

I completely agree about the long term effects of cxl but as I said time is usually against us. The same thing happened with lasik, noone knew about the iatrogenic keratectasia that could be induced but it is still (more carefully nowadays) performed worldwide.

[Andrew MacLean]

That's not entirely right, Pepe.

The amount of data continues to increase year on year, but some of it relates to procedures conducted this year, so that the long term outcome will still take time to be assessed. In a generation's time there will be a clearer and more comprehensive picture, but in the meantime we make do with what is available.

Andrew

[GarethB]

I never said the K3 lenses were at the trial stage. I only mentioned that I am taking part in a trial and some hospitals are running their own.

As I don't work for the manufacturers I can not say if they comply with part or all the legislation that surounds medical devices, only they can do that.

Based on available data CXL treats KC progression and if my daughter shows signs of KC I would inform her (cuurently age 9)as best I can. Compared to when I was fist diagnosed with KC over 20 years to now there have been great advances in KC treatment so I am sure if she were to experience complications at a far later date treatment options will have made another leap forward and she will be fine. As I have said before on the subject I reserve the rihgt to change my mind as more information becomes available.

But just because we have not seen 'all' the information does not mean it does not exist.

[pepepepe]

Definitely there is no finish line in medicine, there is evolution with any method used today and newer treatments that will come to the fore in the years to come by the time treatments which are new treatments today become more older ones. Today nothing has been proven to treat progression like CXL has shown to.

Gareth, what are the Kerasoft trails for ? has any somewhere in the world given any results ?