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574673 tn?1234125978

Explanting ReStor IOL

After going through three months of blurry vision at all distances with my left eye ReStor IOL., I took the advice listed on this forum and submitted an Adverse Medical Report to the FDA. Imagine my surprise to find 50 pages of reports, over 500 of them associated with this lens. Most of them were for my model lens as well. All had similar problems to mine and none were resolved by Yag laser capsulotomy or PRK lasix to fix the power. I understand once they do the Yag it is much more dangerous to explant. Three doctors have confirmed that my capsule does not look blurry and contrary to the typical events, my vision after surgery hasn't changed, verses becomming blury later like most capsule problems. My current doctor recommended a piggy back lens for the power, which he claims is off due to measurement error. This type of procedure is not recommended by the manufacturer of the lens. I sought the opinion of MASS Eye and Ear, a world renowned facility and they said that there were risks in explanting my lens.
So now I am faced with a life of blurry vision that can't be corrected with contacts or glasses. I currently wear a contact in my "good eye", which is -7.5 with a small cataract, a +2.5 in my operated eye to even out my vision so my mid distance isn't half in and half out of focus and reading glasses! My visual handicap was better before the surgery when the only thing I couldn't do was drive at night, which I did any way.
The other alternative appears to be an explant of the left eye, continuing with the right eye wearing a contact. What are the risks of an explant? Would you replace the Restor with a monofocal for far distance and get a far-intermediate contact lens for the right? Acylic verses silicone, which is better?
96 Responses
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Avatar universal
In your place, I'd have the ReStor explanted by a surgeon who was very experienced doing this procedure.  I'd let the surgeon choose the IOL and the material (after expressing my preference for an aspheric monofocal lens).  If my left eye were dominant, I'd target good distance vision.  If it were non-dominant, I'd target either good intermediate vision (modified monovision) or good near vision (full monovision).  (If you've never done monovision, the modified version would be a safer choice.)  Best of luck.
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233488 tn?1310693103
MEDICAL PROFESSIONAL
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574673 tn?1234125978
Sorry but I did not see a comment posted.
londonbridge
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233488 tn?1310693103
MEDICAL PROFESSIONAL
I don't have an opinion on this. Risks including infection, bleeding, retinal detachment, macular edema, continued dependence on glasses, and ending up worse than you are now.  Jodi J has as she always does, given a good advise. I would not put a multifocal IOL in the eye.

JCH MD
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574673 tn?1234125978
Thanks for your advice. I saw another group of doctors assoicated with TLC Laser vision center in Fairfield CT. They did Tiger Woods eyes and have much experience with multi focal lenses. They, like Mass Eye and Ear are recommending leaving the Restor in place since it applears well centered. and doing the Yag laser and fixing the astigmatism with another procedure. They claim they have done this a lot which very good results and it is safer than removing the lens.  Then they will make recommendations for my second eye, which currently only has a minor cataract and is a -7.5. I am not sure if I will get good vision with the two eyes still being so different, one multifocal and one non implanted. But I need to do something since my IOL eye is only 20/50 with blury and doubled vision.
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233488 tn?1310693103
MEDICAL PROFESSIONAL
Good luck.
JCH MD
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574673 tn?1234125978
Thanks. I guess I didn't realize that Jodie J was one of the doctors. At any rate I now have an ulcer on my cornea from wearing the right contact too long and I am left wearing my glasses only with vision for one eye. Very frustrating because I cannot drive to my business trip and my husband has to drive the three hours to New Hampshire. I am a very active 54 year old and feel so disabled by all of this.
Fran
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Avatar universal
No, I'm not an eye care professional--just a patient like you.  I've had several eye problems myself, for which I did a lot of my own research, learning a great deal in the process.  Sorry to read about your corneal problem--I've had similar problems which always resolved.
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233488 tn?1310693103
MEDICAL PROFESSIONAL
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Avatar universal
Restor works best once both eyes are complete.  Restor in my experience is more influenced by capsular haze because of the optic.  Maybe you just need a YAG and will be ok.
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233488 tn?1310693103
MEDICAL PROFESSIONAL
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574673 tn?1234125978
Thank you for your support. At this point I am leaning toward the YAG because of the reason you subbested. My concern was if that didn't work I would be stuck because of the difficulty explanting the lens once the capsule has a hole in it due to the YAG. The group I went to in Fairfield CT felt I would still have options for an explant and they have done them. However they do feel the YAG would help and could also try other procedures for the astigmatism. After I did the Restor and had problems I went to several well regarded experts who did not feel the right cataract was significant, which may have caused me not to do the Restor in the first place, due to having them work best in pairs...Oh well. At the moment I am dealing with a corneal ulcer on my "good, bad" eye from wearing a contact lens so that I could at least see to work. I will never take my eyes for granted that is for sure.
Thanks again.
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Avatar universal
In your place, I would not get a YAG.  Based on all the information you posted on 10/14/08 (above), there doesn't seem to be any reason to believe that you need or would benefit from this procedure.  I get the feeling that when the outcome of multifocal surgery is disappointing, some doctors automatically do a YAG.  Many people have posted here that there was no improvement in multifocal vision post-YAG.  And this procedure does increase your risk of retinal detachment (in addition to making an explant more complicated.)  So please think twice before proceeding.

Even small amounts of astigmatism have been reported to impair vision with ReStor.  How much astigmatism do you have?  Does astigmatism correction improve your near/distance vision during an eye exam?  If it doesn't, it's likely that a refractive procedure to reduce astigmatism won't help either.

For some people posting here, multifocal vision does improve with time (i.e., neuroadaptation).  But this is certainly not always true.  I've been reading this website for almost three years, and I can only conclude that multifocal IOLs simply don't work for many people.

I still think that explanting your ReStor might be your best bet.  Yes, this invovles more risk than a YAG plus a refractive procedure to reduce astigmatism.  (Yet it is not terribly risky when performed by an expert.)  BUT COMPARE THE LIKELY BENEFITS OF THE TWO OPTIONS.  Everyone posting here who has had their multifocal IOLs explanted and replaced with monofocal IOLs has been delighted with their outcome.

I know from personal experience how frustrating and anxiety-provoking vision problems can be.  I hope your problems are soon resolved.  



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574673 tn?1234125978
Thank you once again for your comments. I went to a local Opthamologist for treatment with the corneal ulcer. He is rather conservative compared to the TLC group and agrees not to do the YAG and to do the monofocal explant replacement. It is a good idea to confirm whether an astigmatism correction actually helps. I have had multiple eye exams to date and don't recall seeing any better with restor lens no matter what correction was tried.
In addition several doctors do not feel my right eye cataract is very much at all so it is doubtful I would want to do another Restor, at least in the near future. So if I correct the Restore with Yag and lasix, I would need to find what can work in the non operated eye.
My non operated eye is dominant, so I take it I should correct it by contacts (which I may not be able to wear due to ulcer problems) or glasses. If I choose a far-mid distance monofocal I am not sure if glasses will work with my right eye being a -7. I am not sure if you follow all of this, but if you do I would once again really appreciate your advice.
London Bridge
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Avatar universal
Londonbridge, if you are unable wear a contact in your unoperated eye, you will probably have to have your right eye done sooner rather than later.  (Some soft contacts can function as a bandage while providing correction; check out whether this would be a possibility for you.  And your cornea will heal in time.)

Most people cannot adjust to a difference of 3+ diopters between their eyes (unless they wear a contact lens).  If you wanted blended vision (distance vision in dominant eye, intermediate in non-dominant eye), you'd replace the ReStor with a monofocal IOL targeted for -1.25.  Glasses wouldn't work with your dominant eye -7; you'd have to move up the second surgery or wear a contact.

Unless you're happy with your first ReStor, don't get a second one!  If glasses/contact don't improve your blurred vision, it's very unlikely that LASIK will help.  Possibly (but not necessarily), your vision will improve with time (if you have the patience to wait and see.)  According to the professional literature, neuroadaptation to multifocal vision can take up to a year.
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574673 tn?1234125978
Thank you once again for your patience and advice. I really appreciate your taking the time to help me sort through all of this mess. The idea of the bandage contact is a good one. (It may allow me to at least go back to where I started and be able to drive and work. I am not comfortable at the moment driving on the highway with my restore eye blocked out using only my glasses in my right eye with the ulcer! My job involves travel, which is one of the reasons I did the cataract surgery in the first place!)
It also sounds as if glasses are not an option with a -7.5 dominant eye and a corrected monofocal IOL eye. My question is this. would it help to have the nondominant eye set for an intermediate distance or is that still too many diopters different (sounds like it still is) And if I am able to tolerate contacts again does it make sense to do the nondominant eye for distance and wait to do the dominant eye using a contact for the intermediate. How important is it to do the dominant eye for the far distance. I guess a myopic person who always struggled for crisp distance doing the first eye ( non dominant) for far distance has some appeal. At this point I don't believe I will do the right eye in the near future unless my cataract really progresses. I can see fine with the contact (20/20 for distance in it. and after so much misery I am very reluctant to do anything with my other eye that is unecessary.
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Avatar universal
Most people prefer using their dominant eye for distance.  I used to do monovision with contacts, and I found that either eye worked for distance vision.  But setting your non-dominant eye for intermediate vision is probably the safer choice--ask your surgeon about this.

You're correct--glasses won't work with one eye -7.5 and the other -1.25 (good intermediate vision).  A contact works fine for most people.

I can understand your reluctance to proceed with your right eye given your bad experience with your first surgery.  My own experience with cataract surgery was very different from yours.  I developed a rapidly progressing cataract in one eye only following retinal surgery.  My vision was good enough to watch a subtitled movie at the theater a few hours after receiving an aspheric monofocal IOL.  (I got an AcrySof IQ; I wore a contact in my unoperated eye.)  I was so pleased with my first outcome that I decided to get an AcrySof IQ in my second eye rather than do LASIK.  (I was highly myopic like you.)  If you haven't already seen the patient information video at www tecnisiol com, you should check it out.  Both the AcrySof IQ and the Tecnis monofocal claim to improve night driving ability, and my own experience suggests that there's a real basis for this claim.        
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574673 tn?1234125978
Thank you once again for your help. I will check out the video on the technis monofocal. Did you second IOL have a cataract at all? I have a consult by phone with the Retinal specialist team that I saw at Massachusettes Eye and Ear a few weeks ago. Of all the people I have seen they did the most thorough work up and I trust them.
(I am obviously still struggling with whether the Restor will ever work. The TLC Laser center in Fairfield indicated that they could not tell what type of correction they would need to do either by Lasix or Limbal Relaxing Incision until they did the YAG. because everything will still look blurry due to the wrinkled capsul. It seems as if they should have an idea based on just an office refraction with simple lenses.)
Thank you again. I hope to move closer to a resolution.
londonbridge
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Avatar universal
Get a second opinion before doing the YAG.  This procedure does contribute to the risk of retinal detachment (in addition to making an explant more complicated.)

I didn't have a cataract in my second eye.  My vision with an aspheric monofocal IOL was at least as good (and probably better for night driving) as my best corrected vision pre-surgery.  That's why I'm such a big fan of this type of lens.
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574673 tn?1234125978
Hi Jodie,
Thank you once again for your kind help and that which you give to others.
I saw my local Opthalmologist today and my ulcer, thankfully, is resolving but still not well enough to wear contacts again. ( I may switch to a daily wear if I can go back to them). He also gave me the advice to have the Restor explanted and replaced with a monofocal for all the reasons you and others have recommended. He has another group in Boston that he highly recommends, which would be the third specialist opinion, but I doubt it could hurt at this point. Erring on the side of caution has never been my strong suit, and perhaps is not a bad idea. ( I regret not having sought more opinions prior to this mess already, but of course I put my trust in our family eye doctor of eight years...)

I also had a phone consult with Mass Eye and Ear. They pointed out that my two eyes will not work properly together no matter which IOL I choose without a contact or second surgery, so that issue is resolved, because it doesn't play in to my choices with the first eye.. They definately would not implant a second Restor, but if I kept the first Restor they felt they could do a monofocal with it if I needed surgery. If they did a monofocal they would either do distance or if I was adamant about not wanting the other eye done and could not wear a contact either, they would make the first eye -6.0 to match the other near sighted eye (this seems like a bad choice if I am already needing to have a lens in the left eye). They felt it was possible to do the YAG and lazer correct the Restor to perhaps 20/25 of course no gaurentees and no statistics available on how often this works. They repeated not to do the YAG if there is any chance I would not keep the Restor (so that issue is settled too).
So I am working on healing my right eye ulcer, maybe trying to drive with only that eye with my glasses ( the left lens has a fogged out glass in it) and having a third opinion on the explant verses Yag and Laser for the Restor. I believe I am getting closer to a resolution and am leaning toward the explant if I can find a competent surgeon, which I believe I can up in Boston. (Still a part of me that wants to explore fixing the Restor but I would need to be much more certain of the likelyhood of success before choosing this option).
I have also filed adverse event reports with both the Alcon Company and the FDA regarding my experience with Restor and I encourage others to do the same. They need the data on these problems.
Thanks again for "listening"
Fran
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Avatar universal
Don't even consider making your first eye -6.0!  I can't imagine why anyone would suggest such an option.

I think blended vision (distance in dominant eye, intermediate in non-dominant) is the optimal correction for most people.  With a little luck, you'd only need glasses for prolonged reading or tiny print.

If your ReStor vision can't be improved with glasses/contact lens, then LASIK probably won't work.  

If you don't need astigmatism correction, you might consider trying a 1-Day Acuvue Moist contact.  This has to be the most comfortable contact I've ever worn.

Have faith that your ordeal won't last forever, and your vision will improve.

  
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574673 tn?1234125978
I think the suggestion to make it -6.0 was in response to my saying I didn't want any surgery on the right eye and I couldn't wear a contact and needed to rely on glasses. In that case the only glasses that would work would be if both eyes were nearsighted. This is not the option I would choose. I hope I can return to a contact in my right eye.

I am trying to gather more information about the possibilities of fixing the restor as my family is urging me not to undergo the risk of explantation. I suppose insuring that I could achieve some correction with a contact or refraction would be reassuring before doing laser. The problem seems to be a Yag laser would be done first and then the refractive laser, which obviously increases the explantation risk. ( I know I have been all through this before and I am driving myself and anyone else crazy)

Anyhow do you know where I can find out the reputation of The Boston Eye Center (Dr. Samir Melki) and TLC Laser Vision ( Dr. Eric Donnenfeld). These are the two people I contacted so far who could do either explantation or Yag and laser. They lean toward not explanting.
thanks again
Fran
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Avatar universal
If these doctors are board-certified and have been in practice for awhile (www.aao.org), these are positive signs.  You could check for malpractice suits (probably with the appropriate state agencies.)  I tried both names on www ratemds com; Dr. Donnenfeld had one very negative patient comment, which is difficult to evaluate without more information.

Please re-read your initial post on this thread (10-14-08).  You have listed several good reasons why you would not benefit from YAG.  Why are these doctors insistent that you have it?  Unless they can come up with a reason that makes sense to you, I would question their competence.  (As a formerly high myope who has had cataract surgery, your risk of retinal detachment is already slightly higher than the norm.  Why add to this risk for no good reason?)

It's my impression that the risk of an explant is about the same as the risk of cataract surgery--no higher.  
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574673 tn?1234125978
Thanks again. Still weighing all my options. My ulcer is healing so I hope I can try the contact again. For now I can not drive anywhere which is a big handicap for me since I am on the go 24/7. I will check credentials of both docs some more.
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