Kerasoft IC and K3 Trial

[GarethB]

The issues I had with RGP's started last spring and I've never hidden the fact. I just got on with life like everyone else and adjusted they way I worked and planned my life so I could still earn a living.

The NHS subsidises lenses so I expect to pay the same as an RGP. People who need sclerals pay the same price as those who use a standard RGP and we know sclerals are horendously expensive. The K3 is a three monthly disposable lens and while getting the fit right I did have a lens for the left eye that is still useable and I wore it for 4 months in total. My RGP's lasted 3.5 years and the ones from the hospital although undamaged are uncomfortable by contact lens standards compared to a K3.

I asked about infections and how many they see in eye casualty. Yes they see more infections from soft contact lens wear and my optom then went on to say that of those none are KC patients. They find that peopel with KC take more care over their eye sight because there only means of vision correction is contact lenses so for KC they see no difference in the infection risks.

As I put in my update, my hospital is thinking perhaps they dismiss them too soon, perhaps otehr hospitals are the same. Plus on this forum people generally only post if they are having problems so for all I know many hospitals may well be using them as routine.

plus in my update I did say

For me, I feel I have found the Holy Grail

Rather than a sweeping statement for all and in previous posts on this thread and throughout this forum I have always said what suits one person may be unsuitable for others.

What I will say to people is "Don't knock it if you haven't tried it but ask questions by all means."

[Andrew MacLean]

I think I also posted above that a lens combinationt hat has been a sight-saver for many here proved wholly unsuitable for me. It really is a matter for the individual optometrist who can actually see the patient's eye and the way in which the lens fits.

I could not be more delighted to find that Gareth has found a lens that suits him well. His success does not lead me to believe that the same lens would suit me as well.

Andrew

[pepepepe]

As a UK Charity and a moderater Gareth you should know about new contacts on the NHS in more detail including about the opening up the solutions question. Its not good just to drag you feet on that and at the same time make out your doing all you should be. You say you got them paid for from the Hospital, but you also said they did not give you them to you ?? - make you mind up ! when you are calling them the holy grail in contact lenses. You went through a glasses episode where you was saying that was the "bees knees" and we did not hear nothing after that. Everything you do seems too wonderful to be true.

[private104]

pepe

Why the big attack on Gareth? Did I miss something? Did he do something to upset you? I have always found him a model of openness and helpfulness.

[Anne Klepacz]

Pepepepe - as a regular contributor to this forum, I'm sure you know that we ask all who post here not to make personal attacks on each other and your latest post is heading that way! No one here (including Gareth) has ever said that any lens or other procedure is the answer for everyone. It's great that he's having success with Kerasoft3, but there will be many others with KC for whom they aren't the answer. But the only way we can all move forward is to hear about all the new developments and learn from each other's experiences. Many of us get on fine with rigid lenses, often for many years. But sometimes there comes a point at which the eye stops tolerating them for some reason. Then the more other options we have the better - whether that's scleral lenses, piggy backing, or the new developments in special soft KC lenses.
Anne

[GarethB]

OK, lets clarify a few things.

RGP lenses were provided by the hospital and I paid the prescription charge.

K3 provided by the manufacturer free of charge. Hospital are seeing if they can take over the care, if they do I will have to pay for a set of lenses to be issued to me and I will pay the prescription charge. At this stage I do not know if the hospital will take over my vision care with the K3 lenses.

I don't recall ever saying glasses were the bees knees, the K3 does allow me to switch to glasses but I only just get enough vision to drive in them and they do nothing for my right eye. I suggest you go and re-read my post regarding glasses.

Thanks Private for your support and I am glad you find my posts helpful.

I don't mind people questioning my posts but to be rude about it and launch into personal attacks just leads to people leaving the forum disenchanted and posts being locked or removed that others are finding helpful.

The committee welcomes any sugestions to move solution issues and getting new lenses made widely available in a positive direction. Whate evryone on this forum must remember many of us (I include myself in this) on the committee have full time jobs and famillies to support and I have never hidden the fact my familly and work take priority. Being part of the KC group just allows me to help others just as I had help from the KC group 4 years ago and still do.

I will be standing for the role of Vice Chair within committee at the AGM although I have already sent my apologies due to issues at work (more redundancies). If anyone has any objections to me being on the committee then please make your objections in person at the AGM and I will stand by what ever decision is made by the KC Group in attendance.

Anyone wishing to help the group, please contact Anne and feel free to volunteer and if anyone would like to be on the committee, please contact Anne and she will let yu know the correct way to go about it.

Please can all further discussion be kept civilised.

[Lynn White]

I would like to clarify a few things, as perhaps everyone is not aware of the background of Gareth's KeraSoft trials.

Over a year ago now, I asked members of this group if they would be interested in trialling the new KeraSoft3 lenses. The major difference of this lens to other soft lenses was that for the first time, a new Silicone Hydrogel material was available that could be lathe cut to any design. As Silicone Hydrogel lenses are now widely accepted as excellent for ocular health, it was very exciting to be involved in developing a lens that could offer comfort, good ocular health and vision for keratoconic patients.

A group of willing volunteers, including Gareth, came along to be fitted and actually, at the time, Gareth, of all of the volunteers, was actually OK with his current RGP lenses. He was simply volunteering his services as a subject with unusual eyes, for which we were very grateful. He was also interested in them from the point of view that he does car rallies and that sport requires a soft lens option as he is not allowed to compete with RGPs.

However, over time, his RGP lenses started to cause tolerance problems, so he returned to his KeraSoft lenses as these gave him longer wearing times. It was at this point that we realised that it would take a while for his vision to settle as he came out of his RGPs. I have monitored his topographies and it is clear that changes have taken place as he has settled. Just a few weeks ago we got what we think is about the final prescription which was confirmed this week at his hospital appointment - though I will, of course, continue to monitor. All the KeraSoft lenses he received were part of the ongoing clinical trials and at this point in time, Gareth's trials are completed.

Now that he feels he wishes to continue with these lenses, there is the issue of whether his NHS clinicians are willing to continue with aftercare and supply of lenses they did not originally fit. If they are willing to do so, then Gareth will pay the same amount of money as he has been doing for his RGP lenses under NHS regulations.

Gareth finds the lenses give him equivalent vision to RGPs and all day wear comfort... the main issue was that, despite having a really good RGP fit, it took around 3 months for his corneas to stop fluctuating after stopping RGP wear. This is invaluable information as it helps practitioners to manage patients swapping lens types.

I wish to say that Gareth has been an excellent subject during the clinical trials as he is absolutely scientific and balanced in his evaluations and comments on lens performance. He has gone the extra mile in giving us feedback and this has already contributed to improvements in design and fitting methods. Without this feedback, innovations in the field of keratoconus contact lens fitting would take much longer to develop. I would also like to thank here all the other people who volunteered - many of whom are still actively involved in trials.

This group as a whole provides an invaluable service to the keratoconic community - not only in supporting other keratoconics in distress, but also in enlightening us, the clinicians, as to how the condition affects you and thus helping us to help you. The committee are particularly dedicated, spending much of their spare (or not so spare!) time answering questions put to them by worried people newly diagnosed. Gareth is an exemplary member of the committee and totally unbiased. His diary of the trials reported bad eye days as equally as good eye days and this is as it should be, to further scientific knowledge. He would have been equally honest if the lenses had not worked out.

In a similar way, other members report on sclerals, piggy backing, hybrids, grafting, CXL, INTACS and so on - all of which contributes to the pool of scientific knowledge. Long may this continue!

Again - many thanks to ALL of you who volunteer for any and all of the clinical trials and studies for keratoconus - your help is invaluable.

Lynn White

[pepepepe]

In a long message, Pepe insulted Lynn and questioned the scientific validity of the clinical trials to which she and Gareth have both referred.

The post has been removed, and future personal insults will result in Pepe being suspended from the forum.

Andrew MacLean
Moderator

[matt28]

I think people like Grareth and others on this forum are a blessing in disguise for shareing there experiences and knowledge and without them there wouldnt be such a valuable "tool" of a web forum which im sure has helped people time and time over!!...im off to see lynn myself on the 18th to see if kersoft 3 are an option for me..fingers crossed!!

[Lynn White]

You raise an interesting point there Pepe, about the difference between clinical and scientific trials.

In my post above, I refer to the trials I do as clinical and I am a (clinical) keratoconus consultant (not a "sales" consultant). I referred to Gareth's contributions as "scientific" because he approaches his reporting in an unbiased scientific manner, equally listing pros and cons. I referred to adding to scientific knowledge, because his (and others in the trials) observations supplied information that is useful for designing future clinical/scientific trials. Ideas for scientific study do not come out of thin air. Work in the field tends to go hand in hand with scientific study and compliments each other.

A randomised double blind trial to explore whether Silicone Hydrogel contact lenses correcting keratoconus are "better or worse" than other KC lenses would be difficult to design. Such scientific trials have to face the difficult task of hiding from the subject and the contact lens fitter what lens is being worn in each eye. Only the researcher knows which eye is getting which lens. So we can immediately eliminate comparing them to RGPs/sclerals/piggy backing/hybrids and so on as it is patently obvious which lens is in which eye! In fact, for the same reason, you cannot do a randomised double blind on sclerals vs RGP, Synergeyes vs RGP and so on. Even if you tried to do a RGP vs RGP of different design, this would be difficult as the size of the lenses would most likely be different and the fitting method would be different. Thus the fitter would soon get an inkling of what lens they were fitting to each eye.

So you are left with comparing soft lens with soft lens. OK, you may think one soft lens looks much like another but all the soft lenses for keratoconus on the market at the moment all have different designs and materials which mean the fitting methods are different, so the fitter cannot remain ignorant of which lens he is fitting. Added to this is the fact you are fitting keratoconics who are all different to each other and usually have one eye markedly different to the other. Randomised double blind contact lens trials in the normal population rely on fitting Lens A to the right and and Lens B to the left and comparing the performance. So how can we do this with a keratoconic who may only have KC in one eye? Or a graft in one eye and INTACS in the other?

OK then, perhaps we split the subjects into two groups and have one set of fitters fitting one type of lens and another fitting the other and compare the group results. Subjects are then allocated to the groups randomly. But without any sort of control over the groups, one may end up with a lot more PMD and post grafts in one group and classical KC and subclinical KC in the other. Any one individual's eye may have unique chracteristics, so we are not comparing like with like.

So perhaps we screen the subjects first to try and get the two groups as similar as possible. Apart from this being almost impossible (I have yet to see any two keratoconic eyes that are identical enough for such a study) you would end up comparing lens performance on a very small sample of keratoconus subjects and although the results may be scientifically interesting - after a period of a couple of years or so, you would be no nearer knowing if the new lens type would benefit the wide range of KC out there than you were before.

Double blind trials explore, scientifically, products that have already been designed and manufactured. They cannot create products. Initial research has to invent products and make sure that they do not cause harm BEFORE they are entered into double blind trials and there are government controls in place to ensure this.

What can be done, once the material the lens is made from has passed required safety tests, is compare its performance against other materials in a double blind trial as long as the design is reasonably similar. As I have said before, the material from which KeraSoft is made is currently undergoing several double blind scientific trials. These are not my studies, however, and the the results will take time to work through the peer review system.

The clinical trial I was conducting concentrated on the material/design combination and how it performed and also provided case studies to use as an aid to creating fitting guides for practitioners. Any company producing ANY kind of contact lens conducts these sort of trials. The KeraSoft3 trial incidentally led to the design of the new KeraSoft IC (Irregular Cornea) as it became clear that there are many complicated corneas, many post surgical, which require a more customised lens. Those for whom the KeraSoft3 lens did not work are now being fitted with KeraSoft IC in a new set of trials. This lens design customises the back surface to better fit very irregular corneas and I have been looking at different methods of customisation and comparing how successful they are.

The information gained from such trials feeds back into the pool of scientific knowledge and will be collated and presented in journals for peer review in the future - not as double blind trials but as scientific papers based on the data gathered. This information may be as diverse as corneal shape types, aberrations in KC eyes, dry eye problems or fluctuating vision after CXL - none of which may have any direct connection to contact lenses.

It is in this way that clinical trials designed to aid manufacture of new contact lenses adds to scientific knowledge and very often inspires scientific trials which clarify and refine that knowledge.

Lynn