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non US doctors for IOLs not available here:Synchrony, new multifocals
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non US doctors for IOLs not available here:Synchrony, new multifocals

The newest IOLs  tend to be available for years outside the US before the FDA approves them here,  so I was wondering if anyone can suggest good doctors/clinics outside the US to consider using to get them  I'm still in my forties so it seems it may be worth traveling for a lens I may use for a few decades.

I'd also be curious to hear any comments from anyone who has the newer lenses like the Synchrony (which I heard may not be available for a high myope, around -9 worst eye) or multifocals that may be better for intermediate vision than the ones in the US (e.g. AT Lisa trifocal, FineVision, Lentis MPlus). I do most of my reading on a computer and would prefer to risk needing  correction  for near rather than intermediate. How much luck do people have with  the US available multifocals for intermediate?

I was diagnosed with a rapidly developing nuclear cataract in my left eye impacting vision, but only the start of one in my right that may not cause problems for a while.  I may hold off on doing the right eye and wait for a better lens since I'd read about good results  mixing different IOLs, though I'd also read that some surgeons prefer to implant the same lens in both eyes. I've worn extended wear soft contacts for years so I've no problem using one in the right eye if I wait. I'm wearing multifocal contacts now, and prefer that to the monovision I used for a  few years.
Thanks.
11 Comments Post a Comment
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711220_tn?1251894727
In reality, you should not have surgery in another country unless you are prepared to stay long enough for much of the early healing.  You should also be prepared to pay for any complications.  There will always be another product in the pipe-line that will be better.  Get the "best" IOL that is available.

Dr. O.
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Avatar_m_tn
The problem is there is a major jump in the utility of the IOLs available outside the US. The only accommodating IOL in the US doesn't provide anything close to the accommodation that the Synchrony does, which may be good enough for most near vision but at a minimum is more likely to ensure intermediate.  The newest trifocal multifocals provide better intermediate vision,  a  reduced chance of halo&glares, and better contrast sensitivity.

One high profile doctor quoted in many trade publications, Mark Packer, noted on his blog that:

http://community.modernmedicine.com/_FDA-For-Development-Abroad/blog/5661993/33379.html
"The one-two punch of increasing expense for FDA approval and declining Medicare reimbursement for post-approval application is today restricting Americans’ access to new and beneficial technology.   We are really beginning to feel the squeeze.
I used to tell patients who asked, “Should I wait to have surgery? Is there something new (and better) coming along?” all about the clinical investigations I was involved in and what I thought the outcomes were likely to be.  I’ve stopped doing that.  Now I tell them, “Here’s what’s currently available outside the US.  Would you consider medical tourism as an option?”"
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Avatar_m_tn
I went through a similar process the last few month. Last year in May, I got a cataract in my right eye and vision in May this year was to the point where I could not read anything close up or far away. My vision was not foggy but I saw three images of everything offset from each other.

I spent the last 9 months researching US options, seeing a few local doctors and looking at foreign options. The Synchrony was also high on my list but they do not provide the lens in powers to correct myopia greater than -5 (I'm -7 in my left and -5 in the right) so it was out (from talking to one of their product development people and a few doctors in Europe they did not have any plans to make a version of the Synchrony for high myopes this year -- my conversations were 6 months ago so things may have changed).

I also considered the Crystalens which may have worked wellif target refraction and accommodation was achieved without issues. However, after reading people's experiences with the lens and talking to a few local doctors (who did not have it high on their list of lenses), I did not have high confidence in the lens. From the research I did, it looks like most of the time it works like a good monofocal lens. Given my myopia and a repaired retinal detachement in my left eye (which also has a cataract but is progressing very slowly with no need for surgery now), I did not want to choose a lens which would have implantation complications or need explantation due to movement or decentering or me not being able to live with it, I also did not want to have other procedures (lasik, prk, piggyback iol) to correct vision in case of high refractive error. The halos and other issues with multifocals were a showstoppers (along with the fact that I only needed cataract surgery in the right eye and multifocals do better when both eyes are done). I also wanted a lens with low PCO risk. PCO treatment involves lasers which can damage the retina and retinal detachment is higher in myopes who have had PCO Yag laser treatment versus non-myopes. High myopes in general have a higher risk of retinal detachment so the less that is done to their eyes, the better.

I also considered the Staar Nanoflex (potentially some accomodation) and the Tecnis Z9000 (a very good monofocal). My goals were to get good distance vision (I'm right eye dominant) with some intermediate vision if possible. I'm 42 years old and have another 40 years of life left so whatever was to be put in my eye had to be stable and proven.

So what did I choose?  Since my goal was to get good distance vision with minimal surgical procedures to my eye and IOL power calculation and placement is more challenging in myopes, I researched and chose the Light Adjustable Lens (LAL) from CalhounVision. It is a monofocal silicone square edge (low PCO rates and a proven material) lens and it allows for the power of the lens to be adjusted a few weeks after surgery. The power/shape adjustment uses UV light and the back of the lens has UV blockers in it to not damage the retina during adjustment. You have to wear UV glasses all the time after surgery until the adjustment period is over.

I initially interacted with some doctors in Germany (do a search for Binovision) and came close to traveling to Germany to have the surgery done.  Dr. Ray is correct that you will need to spend 3 weeks to make sure everything is good and safe so it does pose challenges. Luckily, I did not have to travel to Germany as the LAL was approved in Mexico in April. I talked with Dr Chayet at CodetVision in Tijuana, Mexico and had the surgery 2 weeks ago. Dr Chayet was one of the early clinical investigators of the lens and has implanted hundreds of them (not to mention many other lenses used in the US). Having this done in Mexico right next to San Diego allows for easy travel and complications can be managed in the US if needed (CodetVision has a very experienced and dedicated team to deal with any issues).

Thankfully, my surgery went off without any issues or complications. My day one postop had clear vision of 20/25 and has gotten a bit worse (maybe 20/30 or 20/40) in the eye and I can work on a computer when the monitor is about 2 feet away. I do have some slight astigmatisim/distortion (images are slightly longer from top to bottom) but it does not interfere or cause any issue unless I quickly compare each eye and look for the issue. I do see some reflections/shimmer (which have been diminishing) from the lens when point light sources hit my eye from overhead or the side at night but there aren't any halos or glare or any other weird optical phenomena. I can drive at night just fine -- much better than with the cataract.

I travel for the adjustments next week (I'll be there for 6 days) which I hope will clear up the distortion/astigmatism and maybe some of the reflections. It would be great to see 20/20 or better. Various trials and reports from doctors and users of the LAL show that there is a 80-90% success rate of getting 20/20 vision. Additionally, there is some ability to play with asphericity and depth of focus to achieve better intermediate vision as well as maybe some near vision. I will try that out during the adjustments to see if it can work for my situation.  

At this point. I'm very happy with my outcome and experience. Its certainly not for everybody but it is worth considering given the options out there and what ones goals and desires are. If the LAL was not available, I mostly likely would have gone with the Staar Nanoflex or Tecnis Z9000 with the cataract surgery being done with femtosecond laser at my local surgeon's clinic to get the best lens centration and refractive outcome.

I'll post a followup after my adjustments are complete.

-- John







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Avatar_m_tn
Thanks for all your comments, greatly appreciated.

I exchanged email last week with Dr Chayet about the LAL (i do gather there is more potential error in IOL power estimate for high myopes so it did sound of interest) and he mentioned the "Customized Near Addition"  possibility. I know the LAL itself has been well tested for single vision. My concern is there has been less testing of the multifocal add  or Binovision  (which I had run into also) and no published research on it. A multifocal add would be subject to the same potential side effects of other multifocals, with perhaps less time spent designing the multifocal aspects as the lenses that specialize in that feature. I need to research more about the "asphericity and depth of focus" issue which I gather is why some monofocals like Nanoflex do better than others.  

It sounds like the new trifocal lenses    are better with intermediate than the bifocals, and  have less issues with glare&halos and have better contrast sensitivity so they may be worth risking. Unfortunately  Dr. Chayet hadn't dealt with them so I need to track them down elsewhere. I wear multifocal contacts and they work well for me, however  it does seem a safer bet for a permanent solution to go with an accommodating lens if possible, it just sounds like the Crystalens, and even the Tetraflex, may not provide enough to be useful.

Even if the Synchrony won't work for a -9 myope directly, I wonder if I could get lasik to finish the correction or even just wear a single vision contact lens over top of it since the major issue is to get accommodation. I emailed some non-US surgeons who had been referenced in articles on the Synchrony, but I suspect they are too busy due to respond quickly so I may need to track down others.

I may not be able to wait too long before deciding, my left eye was down to 20/60 best corrected 3.5 months after it was at 20/25, though my right eye is fine so at the moment its like monovision. I don't notice vision being foggy, just not fully corrected. Atypical for a nuclear cataract the astigmatism went from -0.75 up to -4  during that time (fortunately the corneal astigmatism is only -0.25 so its not an issue for premium IOLs).
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Avatar_m_tn
Yes. The LAL has not been tested extensively for other types of correction.

Calhoun Vision is in phase 3 FDA trials in the US and those are there to verify safety and long term viability of the lens so I doubt if any of them are doing any special adjustment testing.

I don't have any experience with multifocality and my personal goals were to have a good balanced visual system so I did not explore any multifocal options on the LAL. Right now it looks like asphericity has been the most widely tested with binovision and I'm willing to explore that.

Other non-US lens options for multifocality are interesting. Just be aware that in general the success rate of hitting target refraction is around 30% (a bit less for myopes). So some sort of additional correction (contact, lasik, piggyback lens, etc) will most likely be needed if you want to be without glasses for all distances.

Regarding the Synchrony, I was incorrect in stating that it goes to -5. Its actually -3 or -4 from what I remember in the emails I exchanged with a few cataract surgeons. Having lasik or prk is a possibility if you have enough corneal surface for it. There's also the risk of encountering halo's , glare, dry eye, etc, due to that.My personal opinion is that the less one does to one's eye the better.

The synchrony needs about 3 months for people to get used to it and in general it is installed such that one is slightly myopic so that one relearns how to exercise accomodation to take advantage of the lens fully. I'm not sure which procedure should be done first -- lasik or lens implant. Lasik probably needs a good working eye (and clear lens) to determine correction levels but lens placement is more accurate before lasik. I suppose lasik can correct any lens misplacement but will accomodation be excercised well before lasik is done -- hard to focus if everything is out of focus.  You also have to have the right capsular bag size and a perfect capsulorhexis to get the most out of the synchrony. It also seems to work best with both eyes implanted rather than one. A few German surgeons I talked to stopped using it because they were not getting high success or great results with it. You need a very good cataract surgeon to do this one. Also they have a new model of the lens which has a little bit of a near add in the center to help with reading (Crystalens has done the same for a few models of their lenses). This suggests that the range of accomodation may not be as high as suggested or specified. If you do go the synchrony route, get the best doctor for it (Dr Burkhard **** in Germany is one of the best).

I agree with you that accommodation is the way to go but the current options are limited and success rates do not seem to be very high in general (they look good in small controlled studies though). Its really hard
to make a good choice. After doing all the research and absorbing lots of info out on the internet, I personally went with solutions that were more on the safe/conservative side and still allowed some flexibility.

Good luck in whatever you decide.
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Avatar_m_tn
Thanks for your comments, good luck with the LAL adjustment, I'd be curious to hear how that goes. Do you need to wear the ultraviolet protection even inside prior to adjustment?  

I had   checked with the Synchrony folks about clinical trials in the US and they mentioned a new variant to help out with near  but wouldn't give details, so I wasn't sure if it was a multifocal add or a change to provide more depth of focus or something.

   For anyone in the US interested in getting it here, they are just figuring out the trials now so it will be another   few months at least, and unfortunately  the trial will be randomized so you might get a monofocal lens instead. He did say he didn't think they'd have a power that would work for me, though I hadn't realized the current model had such a limited power availability as well, he didn't comment on that.

The Synchrony is sounding less promising, even though I'm ok with the need for LASIK or single vision  correction over top,  since I likely will need it in the future even if whatever I get now fixes my vision temporarily. My left eye has been getting more myopic steadily, even if slowly, over time (it didn't  stabilize in my 20s as most people's do), as has my right to a lesser degree and I don't think that was just due to the cataract.

The Tetraflex doesn't sound like it provides much if anything beyond the Crystalens, so I suspect I'll consider the non-US trifocals. Though the LAL or a monofocal and just wearing correction may be a safer bet since I know multifocal contacts work for me  and if I ever had problems they are  a bit easier to change :-). It just would be nice to perhaps go a few years without correction, and to only need single vision correction when I do.



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Avatar_m_tn
Apologies for taking so long to respond. I had taken significant time off work for cataract surgery and adjustments and had a lot of catching up to do. Additionally, its summer I've also been spending time with family.

The adjustments went well and i now have 20/20+ distance vision in my eye that had the cataract. I had two adjustments. The first was to correct sphere and cylinder  and get vision to 20/20 or better while the second was to correct a bit of astigmatism.

Before my adjustments, my vision was 20/40+ with some aberrations (squares looked rectangular). I was a bit over a half diopter off from 20/20 and this is generally considered a good result for cataract surgery. After adjustments, I see better out of the eye then I did 25 years ago when I first got contacts. My vision still may improve a bit as my eye heals -- I was left slightly myopic (.2 Diopter) after adjustments. This was done intentionally since the lens usually shifts a bit hyperopically after capsular contraction. If such a shift occurs, I should be very close to plano with maybe 20/15 vision.

Unfortunately, we did not try out any asphericity adjustments to allow near vision. After discussion with Dr Chayet, he felt that I needed the sharpest vision distance vision in my dominant eye. Asphericity, tends to create blur and the visual system handles it well for static images but when things are moving it takes longer for the visual system to recognize details. When it comes time to do my left eye we can try asphericity then and adjust it to my satisfaction to allow good close vision and adequate distance vision. We did not try any near add adjustments either. This creates blur and distortion and was not something I wanted.

The adjustments themselves were interesting. The UV light used to adjust the lens is very bright and intense -- its like looking directly at midday sun for up to 2 minutes (with pupils fully dialated). After adjustment, vision is pink for weeks. The lock-in adjustment is the most intense and it left me with pink vision that gradually decreased to normal over a period of 3 weeks. The intensity of the adjustment and pink residual tint to everything was the most annoying part of the process. But the end result was well worth it.

Right now my right eye is dominant for distance and intermediate and my left eye is good for reading and close as well as distance (although contrast is reduced significantly due to cataract). My visual system has adjusted well to all the changes and it's all seamless without me noticing transitions from far to near. I'm able to continue work as a computer programmer without issues. One small anomaly is that everything I see through the right eye is slightly larger than as seen in the left eye. I'm assuming this is due my contact being on my cornea while the IOL is actually in my eye and the fact that my right eye is smaller axially resulting in -5D versus -7D for the left. This is only noticeable when switching between eyes quickly. Hopefully it gets better when it comes time to do the cataract in my left eye.

So overall the LAL in my experience is a great success. It works as advertised. The patient has to dedicate more time for desired results from this lens but in the end it is worth it. Dr Chayet is an excellent surgeon and has a great team working with him. While cataract surgery outside the US is not for everyone, there are great options out there allowing people to achieve desired outcomes. Its worth looking into if you are not happy with US options.

When it comes time to do my left eye (probably within a year) I will be choosing the LAL again unless some other IOL becomes available which is significantly better with good refractive outcomes.

Please feel free to ask any questions and I'll do my best to answer.


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Avatar_m_tn
I see you guys are ahead of me with your IOL research. My left eye with its slow growing cataract will probably last another year or so before really needing a Synchrony or ???.

My "good" eye is -6.5D, and my bad eye is now at -11D and growing, as its cataract continues to expand, but under optimum conditions it still sees 20:25.

I saw a one-line report that the FDA approved Synchrony ~4 months ago, but nothing more. They got their CE shortly before that, so I presume that they are ramping up production.

How do you get information from and about Visiogen? I have been unable to get any response from them. Scented emails?!!!

As an engineer, my goal is the best possible corrected vision. It would be nice to be able to go around without glasses, but not nearly as important as things like being able to drive at night and see tiny details in things that I examine.

Also, how might I find out about clinical trials?

Thanks in advance for your help.

Steve
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Avatar_m_tn
I'm curious what the LAL and followup adjustments cost in $USD at the CODET center run by Dr. Chayet in Tijuana? Thanks.
Steve
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Avatar_m_tn
Yes. Dr Chayet runs the center.

My costs were $3900 last year + travel.

My LAL is still doing great.20/20 distance as of my last eye exam a few months ago.

I have not looked at the Synchrony much lately but it does not seem that much has changed. Very few new trials or studies and some clinics in Germany stopped implanting it.

You may want to explore Binovision with the LAL.
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Avatar_m_tn
Hi,
It sounds as though this lens does what it says on the tin. I have 4 incision RK with hyperopic shift and the beginning of cataracts. Apparently the LAL is THE lens for us RK people as you can adjust the refraction which can be unpredictable because of the distorted cornea. Apart from your distance visual acuity which sounds great, what is your experience with glare, halos and all the other side effects? Are you getting any colour distortion or is it all totally satisfactory. Here in the UK the lens costs £6k (each) with all the aftercare and I am wondering whether I should try Germany where it is a little cheaper and Thomas Neuhann seems to be the LAL man in Germany in Munich. Also wondered is it true that if you have monovision and lose all accommodation after the natural lens goes that you cannot see anything closer than 10 feet in front of you?
Timotea
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