This first week of my blog I am summarizing some of the exciting new technologies presented at the joint meeting of the American Society of Cataract and Refractive Surgery (ASCRS) / University of California, Los Angeles (UCLA) Jules Stein Institute in Century City.
Yesterday I discussed the most exciting new IOL technology on the horizon for monofocal (single-distance) IOLs. Today, I’m going to talk about what I think is the most exciting technology in the “presbyopia-correcting” IOLs.
First, a word about presbyopia. When we are young, our eyes are able to focus over a wide range from distance to near. As we age we lose this ability to change focus. Eventually, we need to help our eyes with the near portion of this range with reading glasses, or “cheaters.”
Currently, the only options available to return that range of vision involve removing the natural lens (or cataract) and replacing it with a multifocal IOL (more on these in a future post) or accommodating IOL. The problem with current multifocal IOLs is that they result in little rings around lights at night. The problem with the currently available accommodating IOL (the Crystalens®) is that is doesn’t work for everyone. So, what’s on the horizon…
Synchrony IOL
Visiogen
This lens was presented by David Chang, M.D. (UCSF) who is one of the most impressive cataract surgeons alive today. It uses a unique two-lens approach to providing a range of vision (distance and near) after cataract surgery. Once inserted into the eye these two lenses would move relative to each other resulting in a variable range of vision.
Unlike most presently available presbyopia-correcting IOLs this lens does not result in halos or glare after surgery. The initial results are very impressive and I am looking forward to offering this IOL to my patients as soon as it becomes available in the US.
As it is such an unusual type of IOL (two lenses instead of one) many surgeons will not be comfortable implanting this IOL when it first becomes available. Nevertheless, this may be worth searching out as the initial results are quite impressive. I’ll keep this blog posted when new results are available as I’m very bullish on this IOL.
© 2009 David Richardson, MD
Hello Dr. David,
I just read on a site last night that a patient is not a good candidate for the Restor lens if used to replace another explanted IOL, in my case, the Nanoflex lens. Is this true?
I just realized today, that within 10″ from the microwave, I was able to read fairly well the instructions on the unit with my Nanoflex eye. Do you think this is due to the distant vision loss I have right now because of needed Yag, or is it possible that even though I need Yag for waxey vision, the lens has been progressing and will give me some close vision? What a nice bonus that would be!
Love to hear your comments.
Norma
Norma,
I’m afraid I have answered all questions that I can with regard to your situation. Any further ability to answer would require an in-person exam. I am hopeful that you will find someone near you who has the skills and answers you seek. I am sorry I cannot provide further assistance.
Hi David,
It’s me again! I just called your office and thought I could come to you for consultation/eye surgery. It turns out you are very close to some of my relatives which eliminated the problem of where to stay, but, I also found out that you no longer take Medicare, which I am now on. I asked your receptionist if I could pay you and them get reimburshment from Medicare, but that is not an option. This is when I wish I could win the lottery, except that I never play.
I don’t mind traveling. DO YOU KNOW A EYE SURGEON ON THIS COAST THAT YOU HAVE A LOT OF FAITH IN? It could even be the New York area, or Connecticut, since I have relatives there also. Also, northern Va., Maryland, North Carolina.
I ask this question because if the Restor lens is eplanted, it makes sense to have a doctor who polishes anterior/posterior capsule & removes (LEC) during surgery as you said you do with the Nanoflex lens. I say this because right now the R.E. Nanoflex lens is badly in need of the Yag. I am looking through “saran wrap”, vision now about 20/30. I should have already taken care of this, but in the meantime, my vision in L.E. Restor has improved to 20/25, granted it did take 18 mos. Night glare is not too unbearable, and so looking back, I wonder why I just didn’t stick with Restor. At the time, I just didn’t have a crystal ball.
I feel that a really competent doctor could tell upon examination, tests, how well I would do with the Restor R.E. after it has been yagged if I keep this lens, and whether or not keeping the Nanoflex can be made to cooperate with the Restor eye. In other words, I know it is not an ideal situation, but could it made to work? I still have slightly fuzzy vision in Restor eye, but maybe Yag cleans this up and 20/25 will feel like heaven?? It would help me to know if I just went with Nanoflex in both eyes, how much will I need readers, will it be every waking moment? And lastly, I would like a doctor who does his own Yags. I know I sound repetitive, but I am really in Limbo, just going forward, and trusting everything to my doctor’s discretion, “see as we go” kind of approach, bothers me. We both know, that once IOL is yagged, that’s it. There no turning back.
Any light you can shed on the above questions, and referrals you might have, will certainly be appreciated.
Norma
P.S. Anna, your receptionist, was very kind and helpful.
I’m afraid I do not know any doctors on the east coast who implant the Staar Nanoflex well enough to make a recommendation. Sorry.
Thanks, Dr. David, for letting me know so quickly that you are not familiar with any doctors here on the east coast.
The doctor that I presently have is experienced with Nanoflex. He is the one who did my right eye. However, my guess is that he doesn’t polish anterior/posterior capsule, as well as remove (LEC) cells during surgery. If he did, I don’t think I would now have the what seems like a lot of PCO in the Nano eye. It is awful, and thankfully, technology is such now that something can be done about it. Can you imagine looking through saran wrap for the rest of your life??? This is why I would love to have found a doctor who does explants, and follows the procedure that you do, it could mean less PCO.
No one in your clinic that you have trained? I’ll go to the ends of the earth at this point.
Norma
Although I do not know him personally, Dr. Ken Lipstock in Richmond, VA was mentioned by my Staar representative.
Hi, I know of Dr. Lipstock. He loves blended vision with Nanoflex lenses. I don’t think he like to do explants, and I would need this to implant the Nanoflex.
I don’t know if I’ve already let too much time go by to explant the Restor anyway. I would assume the sooner explanted, the better. This eye has never been yagged, and I think I read where Restor is one of the easier IOL’s to explant.
What is your opinion on this? Too late – over a year??
Norma
Earlier explantation is always preferred regardless of the IOL. I’m not sure where you would have read that the ReSTOR is “one of the easier IOL’s to explant.” In truth, the single-piece ReSTOR is one of the more difficult IOLs to explant (not true for the 3-piece ReSTOR which is rarely used in the USA). The single-piece ReSTOR haptics have bulbous tips that can be exceedingly difficult to remove once the capsular bag has scarred down around them. Often it is necessary to “amputate” the haptics in order to free the IOL from the bag. It all depends upon how much capsular fibrosis has occurred (something which cannot be determined until the time of actual surgery).
If you would be interested in exchanging the ReSTOR for a Crystalens, I believe that Dr. Stephen Safran in New Jersey has performed a number of ReSTOR exchanges for Crystalens IOLs. If anyone on the east coast could successfully perform such an exchange a year out from surgery I would place my bet on him. As you know, I’m not the biggest fan of the Crystalens IOL, but Dr. Safran seems to have mastered the nuances of this challenging IOL. Considering that it is even more challenging to obtain a desired result after IOL exchange, these nuances become even more critical.
BTW, I’m not aware of any surgeon who “likes to do explants” as they are both more challenging and less predictable than primary cataract surgery. As both expectations and risks tend to be higher with IOL exchanges, it sets up the surgeon for potential failure in the eyes of the patient. What’s to like about that?
Thanks for the info. re: Dr. Safran. And you are so right, IOL exchange is a scarey business. If I can make the two lenses I now have work, Restor, L.E. and Nanflex, R.E., then so be it. I ‘m so over all of this.
Again, thanks for everything.
Norma
Hi Dr. David,
Have been using eyedrops for dryness (Restor L.E.) for about a week now, everyday, but not quite making it every hour, but I am starting to get some relieft from the “foreign object sensation”, so I think I will hold off on a “plug”. I know I mentioned this to you last week, but one question:
Do you think it is possible that once the Restor is explanted and implanted with the Nanoflex, that even though the eye is dry, I will have less of a foreign object sesation? I ask this because the Nanoflex seems to tolerate dry eye better. I have dry eye in (R.E. Nanoflex), but am totally unaware of any discomfort. Maybe it is less dry?
This is probably difficult to answer, but thought I’d ask anyway.
Norma
IOL exchange is unlikely to have any significant impact on foreign body sensation.
Thank you, Dr. David, for your comments of April 24th. I agree completely. Unfortunately, none of this important info. was relayed to me the day we decided to do Restor lenses. My plan with the 2nd Dr. was somewhat opposite of what we probably should have done. Instead of implanting the Nanoflex R.E for distance., explant the Restor first. This would have given me the opportunity to wear a contact in the R.E. to see if I could handle blended vision. Now I don’t think I will even bother, as I am sure I already stated, Restor Lens plus dominant L.E. does not make for a good trial. I fear I will really see strangely. Even at this point, if I said, “Gosh, I’m doing pretty good, after 18 mos., with the Restor L.E., maybe I should explant R.E. Nano, I would then most likely have the same problem with the “foreign object sensation” because this eye is also somewhat dry, and the Restor lens is not so forgiving when it comes to dry eye. Of course, I wouldn’t do this anyway. It just that in my mind I’m going through possibilities. and various scenarios. I want to go forward with educated decisions this time. In my heart & mind, I am beginning to accept that I will be wearing readers A LOT/ALWAYS! Hard to find much info on the Nano on line, but what little I saw states how Staar is trying to get Nano approved as premium lens. I fail to understand why, but what do I know? It seems some patients are seeing pretty good with near vision. My guess is that these patients are probably not that presbyopic and do better than the patients whose presbyopia is severe enough that they need readers.
I can’t tell you how much I appreciate your keeping in touch with me. I promise I will soon disappear into the woodwork. You are the only on-line doctor who has been so straight forward & helpful. I truly wish you weren’t so far away.
Have a wonderful weekend, and may you always be blessed with good fortune.
Norma
Hi Dr. Richardson,
Hope this comment reaches you as I am not sure I am doing this right. I have a Nanoflex implant, right eye. After 2 wks., PCO set in, now need Yag. Vision has dinished from 20/20 in the beginning, now 20/25.
Ques: Do you think 20/20 will return after Yag?
I have a Restor lens in the left eye which is off by 1/2 dioters, it fluctuates between 20/30 & 20/40, also needed a Yag after 2 wks. which I didn’t do. I would need Yag and maybe PRK to get better distance, but I will most likely jeopardize the near vision, mostly good only in bright light, but still a smeared image. I paid $3100 for this premium lens. The doctor who put in my Nanoflex (right eye) says that it is still not too late to explant. He did not implant the Restor.
Question: Do you think I could do a mini mono-vision with Nanoflex if we do explant the Restor? I don’t think I can try this with a contact lens because it would probably not be a perfect scenario since Restor has a refraction already in it.
My doctor says we can shoot for good distance vision & intermediate in both eyes, but I will have to wear reading glasses.
Questions: When he says readers, I’m not sure he means for tasks like reading, sewing, makeup, etc., or does he mean for anything within 16 to 20″ out? I assume this would mean glasses all the time.
How will my intermediate be with Nanoflex? It seemed okay before PCO set in.
I have heard that the Nanoflex gives very good distance vision, which I experienced for about 2 wks. crisp & clear. Hard to remember now, but I think intermediate was good, for ex. 5′ from my eyes. Forget close up, although I was told that I should be able to see large headlines with this lens, but that indicates to me that I would not need to have glasses on all the time. I am probably wrong about this.
My doctor really believes in this lens, and says that he has had consistent and good results using it.
I keep procastinating as though I am at the crossroads of my life with my eyes. I am asking for your professional opinion because my doctor just doesn’t communicate, but it is his expertise that I need, still it would be nice to know the answer to some of these questions.
I’ve read everything I could possibly find on this site re: your blogs and answer to questions. You are really great!
Thanks so much for anything you can share with me re: the Nanoflex and my related questions.
Norma
Norma,
You have some very good questions many of which, unfortunately, cannot be answered without actually examining your eyes and taking multiple in-office measurements. The best I can do online is to provide the most detailed general information about the technology that is available. Specific questions about how your eyes might do are beyond what anyone can answer online. Indeed, even with an exam and measurements the real answers to questions such as “How will my intermediate be with Nanoflex?” can only be answered by going ahead with YAG capsulotomy. That being said, if your initial vision was 20/20 prior to developing PCO then a return of crisp distance vision with YAG laser treatment may be a reasonable expectation. I’m sorry I could not be more helpful.
Hi Dr. David,
I believe I read where your practice is in California, I wish you were closer. I’m in Virigina.
I read your response to Mira re: PCO, stating that you polish anterior/posterior capsule as well as remove the lens epithelial cells (LECs) during surgery. I don’t know if my doctor did this, but I wish he had. He told me to come back for Yag 3 months after surgery, but it’s been longer. I know, I’m a big baby? My right eye, Nanoflex, is the eye that not only has posterior vitreous separation as does the left, but also has a retinal tear that was lasered. The accident that caused the PVS and retinal tear was at least 20 years ago. So, yes, I do get nervous about too many procedures, especially in the right eye.
Question: Am I over-reacting?
Best regards,
Norma
Norma,
The risk of retinal detachment after YAG capsulotomy is small, but not zero. I encourage my patients to consider the risks but keep them in perspective. For a small visual annoyance, any risk might be too great to consider. Then again, 1,000s of people choose to have LASIK each year (a procedure that has substantial risks) in order to cut out the annoyance of wearing glasses. Risk tolerance ranges greatly from person to person.
Once again, Dr. David, thanks for your speedy reply.
Years ago, I was going to have lasik surgery, I was told I was a good candidate even though I had the beginnings of cataracts. ESP kicked in and I went for another opinion. Doctor said don’t do, and so I didn’t.
I feel I must do the Yag in Nanoflex eye because I have noticed deterioation in vision. Not only now 20/25, but over-the-counter mangifiers for reading are not working as well anymore, so it must be done. Distance vision is not clear at this point either.
Question: My surgeon does not do Yags. He has a “fellow” doctor do this procedure. Can I feel positive about this, or am I overacting again?
On a lighter note: I read a blog on line that I thought was really funny. Someone wrote and asked the surgeon if the eye procedure was done while awake, the surgeon replied, “Yes I was, and so was the patient”.
Awaiting your reply.
Norma
Norma,
Your surgeon must be very busy indeed if he does not even bother performing YAG laser procedures himself. In general, the YAG capsulotomy procedure is a “low risk” surgery (but as with all procedures there is still some risk). It is also not a technically difficult procedure though some doctors are clearly much better than others at minimizing the creation of pits in the IOL. Fortunately for you and others who have the Staar Nanoflex IOL, all but the largest YAG pits tend to resolve with time (something that is not seen with other IOL materials).
Hi Dr. David,
Yes, I guess he is very busy, so busy that it has been 3 weeks and I cannot even get him to respond to my last email, actually he has never responded to any quesitons, except when recently forced to by his secretary. I find this frustrating. I feel as though I am not entitled to getting questions answered. I also feel that I am entitled to know, or least discuss possible solutions with what he may be thinking of doing. I know that I already told you that I really want his expertise, but in all honesty, if I could find another doctor who can explant, if need be, and has experience with the Nanoflex lens, I would switch doctors. I realize how important time is to all doctors, and it is hard for them to give much indicidual attention, but to take me down a path with no explanation is really disheartening. He said we would put Nano in right and make a plan for the left eye, so what is the plan.
Sorry if I sound frustrated, but I truly am.
Question: Am I foolish to just go ahead and make the appointment for the Yag in Nano right eye?
Trust his judgement without knowing what is planned?
Would I be out of line asking the “fellow” who will do the Yag how much experience he already has doing this procedure?
I will call Staar to see what other doctors I can find who implant the Nanoflex.
Is there any other way I can find a really reputable doctor? I don’t mind traveling some, the eye clinic I use now is nearly 3 hrs. away.
Thanks again.
Norma
Norma,
I can understand your frustration. Unfortunately, the only way to get the answers to the questions you are asking is one-on-one with a surgeon who implants the Staar Nanoflex IOL. If your surgeon is unwilling or unable to do so then it may be time to seek out a second opinion.
Hi Dr. David,
Finally got a reply from my doctor, but only because I emailed his secretary and told her I needed him to answer my question.
Why do I feel like the culprit here?
He said I could try the contact to see how I would do with monovision, but it may not be to good a scenario because of the Restor lens implant. Also, I think he forgot that this is also my dominant eye, which is usually always set for distance. I emailed him again. This sure is getting crazy.
I know of several other doctors who implant the Nanoflex lenses, but one I already checked with does not like to explant lenses. I will check out the other two.
Hope you have a good evening.
Norma
No surgeon I know of likes to explant an IOL (it’s significantly more challenging than cataract surgery).
Hi Dr. David,
I finally made an appointment to get the Yag done on the Nanoflex eye. I am uneasy thinking about it because I know once it is done, I will have to deal with correction for my presbyopia. I think what little near vision I have with the Restor lens has somewhat spoiled me. If only I had faith that a Yag/PRK was the right way to go, I would have probably had the right eye also done by now with a Restor lens and this procrasting that I
put myself through would not exist.
I just found a doctor here in Richmond who implants Restor lenses – I thought about a consultation with him to get his opinion as to how severe will my presbyopia be if Restor is replaced with a Nanoflex lens. Then both eyes will have Nanoflex monofocal lenses. I seriously want to know if I will need glasses for near vision all the time. With his examination and in-office measurements, wouldn’t he be able to answer this question for me?
I know that I mentioned this to you before – my doctor finally told me I could try a contact lens in Restor eye to see if I could do mono-vision, but I seriously think this may be a waste of time since this eye is also my dominant eye. Am I wrong in assuming this is not the way to try mono-vision?
Your answer to the above two questions will be most appreciated.
Norma
Norma,
Predicting final uncorrected near vision with either ReSTOR or Staar Nanoflex is a bit art and a bit science. An exam is necessary and a contact lens trial can be beneficial in making the assessment. Ultimately, however, no doctor can be certain of the outcome prior to surgery. This is one of the reasons I tend to err on the conservative side with my treatment recommendations.
Hi Dr. David,
Hope all is well with you.
RE: Your April 13th answer regrding exam & contact less trial. You said no doctor can be certain of the outcome prior to surgery. Also, this is why you tend to err on the conservative side with your treatment recommendations. You lost me there, would love a little more input.
I know that I told you I have bilateral PVS and horseshoe tear right eye retina. Is it possible that I was never a good candidate for the Restor lens in the first place?
Left eye (Restor) sometimes has a foreign object sensation @ 3:00 position. Do you think this is dry eye, or do patients sometimes express this feeling with multi-focal lenses? I don’t have tearing, itching, scratchy feeling, pink sclera. Don’t wake up mornings with any eye discomfort. What could it be?
Thanks for your help.
Norma
Norma,
All I meant by “no doctor can be certain of the outcome prior to surgery” is that we can’t tell the future and nothing is guaranteed. By “conservative” I am simply stating my general preference for choosing treatments that are more likely to be forgiving (thus my preference for the Staar Nanoflex over the B&L Crystalens).
As for prior retinal tears, they seldom play a role in my choice of an IOL. One exception would be if the tear was really a macula-involving retinal detachment in which case I would not recommend a multifocal IOL.
Although I cannot comment on what is causing any symptom you might be having, with regard to foreign body sensations in general these are almost always secondary to ocular surface issues (such as dry eye syndrome). It is exceedingly rare for an IOL to cause any sensation at all.
Hi Dr. David,
Thank you for your, as usual, excellent feedback.
Saw a dr. here re: dry eyes, he wanted to plug Restor eye, said that multifocal lenses are not as forgiving with dry eye. Must be, because dry eye right eye, nanoflex, gives me no grief at all. I decided to just try eye drops for awhile instead. Dr. said use everyday for 2 wks. every hour, so I will abide.
My Nano eye refracted at 20/30, so I have to stop being a big baby & go & get the Yag. My Restor eye refracted at 20/25 (this only took 18 mos. to do – duh!) Vision smeared, but maybe would clear with Yag. Now I know what my dr. meant when I overheard him tell the fellow to set me up for Nano Yag & then he would check the disparity. Right now it is like major mono-vision. Can one get use to this difference in near vision? I hate the thought of wearing readers 24/7, but this sounds like where I’m headed, especially if I have 2 Nanos’.
Dr. David, In your opinion, do some of your patience do fairly well with the Nanoflex lenses in both eyes, even though they are also fairly presbyopic – you can tell me if I’m unrealisitc, its okay!
Like the Catholic nun said on TV, God does hear your prayers, you’re just not getting the answer you want.
Best ever,
Norma
Norma,
I have both happy ReSTOR and Nanoflex patients. I also have a few less than thrilled patients who have had ReSTOR IOLs placed. I find that in general the Staar Nanoflex meets my patients’ expectations. Than again, that may be because I manage those expectations prior to surgery. I specifically state that to experience the fullest possible range of vision both eyes will have to be done with one eye set for distance and the other eye set for intermediate. I am also very clear that even with the Staar Nanoflex blended vision option spectacles may be required for very small print, viewing objects closer than 14″ from the eyes, and night driving.
There is currently no pseudoaccommodative or multifocal IOL that can give a full range of spectacle independent vision in all lighting conditions. Every available option involves compromise.
Hello dr. David,
There is incredible amount of information about nanoFlex lenses here more than any other site and I truly thank you for time and knowledge.
I am in my mid fifties, hyperopic, and have “managed” dry eyes. I don not have cataract but my vision is really poor . I am considering NanoFlex monofocal lenses using blended vision. They sound wonderful and wondering why ther are not more acknowledged between surgeons.
I read at medhelp a doctor saying that nanoflex have higher incidence of PCO and are prone to pitting when laser is needed in yag. Is that true in your experience? Also what s reasonable number of nanoflex surgeries for a surgeon to have in order for him to be experienced with thoses lenses.
Thank you Mira,
I can’t say for certain why the Nanoflex is not embraced by more surgeons, but I have a few thoughts on the subject:
1) It’s a plate haptic IOL. When plate haptic IOLs first came on the scene they were made of silicon which is a slippery, springy material. They could not be easily folded with forceps so required injectors to get them through a small incision. As these IOLs left the injector they did so with significant speed and force. I’ve even seen a video of one that jumped out of the injector through the capsular bag and into the back of the eye! That was probably the last silicon IOL that particular surgeon implanted. The Staar Nanoflex, however, is not made of silicon. I’ve found injecting it to be controlled and stress-free. Many surgeons, however, may simply not be willing to try another plate haptic IOL after their initial experience with silicon plate haptic IOLs.
2) Staar is a relatively small company compared to Alcon, AMO, and B&L (the big three IOL makers in the USA). As such they simply don’t have the marketing budget to compete. Hate to break it to you, but doctors are just as likely to be swayed by marketing as anyone else. Whether it’s laundry detergent, a car, or an IOL, we are all influenced by familiarity with a brand. Indeed, marketing studies have supported that familiarity breeds trust so the most heavily marketed brand tends to be trusted for that reason alone.
Does the Staar Nanoflex have a higher incidence of posterior capsular opacification (PCO)? That depends on what you are comparing it to. In my own experience I have not found that to be the case. However, I take the extra step to polish the anterior and posterior capsule as well as remove the lens epithelial cells (LECs) during surgery. These steps can be technically challenging, take more time, and are simply not performed by many surgeons. Nevertheless, there is growing evidence that these steps decrease the rate of PCO. If I were to leave the LECs in the eye then I do think that the rate of PCO may be higher with the Nanoflex than the more commonly used acrylic IOLs…but I don’t leave the LECs so I’ve not seen a significant increase in the rate of PCO in my own patients in whom I’ve implanted the Staar Nanoflex IOLs.
YAG pitting is an interesting aspect of this IOL. At the time of the YAG procedure pits do appear larger with this IOL. That being said, by the next day these pits have all but disappeared! With all other IOL materials, the pits created at the time of surgery stay the same size for the life of the patient. Ultimately, however, pits in any IOL are unlikely to cause a significant disruption in vision so I would never choose an IOL on this basis alone. Come to think of it, I doubt I’ve ever even considered this in my choice of IOL so I can’t imagine why anyone else would use YAG pitting as a reason to avoid use of this IOL.
Sometimes one makes a choice and only later finds reasons to justify that decision…
What are your thoughts on the toric NanoFlex? I understand it’s been available in Europe for some time now. Alternatively, what are your thoughts on combining the Visian ICL with an IOL to correct astigmatism?
As the Colamer Toric has not been FDA approved in the USA I have no personal experience with it. Most likely it will not be available in the USA until 2014. It is approved in Europe but not yet widely available.
With regard to the Visian ICL it would be unusual to combine that with an IOL. Most surgeons would either do a clear lens exchange with an Alcon Toric or place a Staar ICL and address residual astigmatism with corneal refractive surgery (LRIs, PRK, or LASIK).
I am a 65 year old male with bilateral -8 myopia and mild -1 astigmatism in my right eye. I have recently developed cataracts that manifest in double vision or ghosting in both eyes. The first opthamologists that I consulted recommended the Acysof aspheric for left and Acrysof aspheric Toric for the right eye. I was initially hoping for an accommodating lenses like Crystalens, but he said he had stopped using them because “they don’t work”. In doing research on the internet I had become impressed with the nanoflex lens. It offers some accommodation without significant added cost. He had no experience with the nanoflex lenses. I have large pupils and have always had problems with halos at night. I have worn daily wear soft contacts of various types for 40 years. I now also use a progressive +2.5 glasses with my contacts for reading. Does the nanoflex seem like a good option for me, and can you recommend a doctor who uses them within a 100 mile radius of Defiance, OH. Thanks
Dear Michael,
Although I cannot state with certainty that the Staar Nanoflex would be an appropriate IOL for you, most patients who choose this IOL do very well with at least some pseudoaccommodation. In my hands it provides almost as much range of vision as the Crystalens IOL with a more predictable refractive outcome (and no chance of a “Z-syndrome”). That being said, not everyone is a candidate for the Staar Nanoflex as it is a “plate haptic” IOL. Unlike “3-piece” IOLs, a plate-haptic IOL requires a perfectly intact capsular bag. Additionally, in high-myopes the appropriate IOL power may not even be available with the Staar Nanoflex (in which case I default to the LensTec SofTec HD IOL).
Unfortunately, I do not know of any surgeons in your area who might be using the Staar Nanoflex or LenTec SofTec HD IOLs. These IOLs are essentially “sleepers” as neither company has the marketing budget of Alcon (maker of the Acrysof IOL). I would recommend that you contact Staar directly and ask who they sell their IOLs to in your area.
Comment
Dr. Richardson,
I learned a year ago from my optometrist that I could no longer be corrected better than 20/25 with glasses (-6.50 -.50 x 180 and a -7.00 Sph. w/ 2.50 Add) due to cataracts but after going to an ophthalmologist I was told the cataracts weren’t bad enough for insurance to pay for surgery; he did however recommend a multifocal IOL for 6 to 12 months later when they worsened. My vision is now worse and I’m doing some research. I’ve found your site to be the most informative; however I am a bit confused with all the options as to which way to go. The Tecnis or ReStor IOL’s seemed previously like favorable multifocal options due to the possibility of little to no additional corrective lenses under most circumstances but I’m a bit concerned about glare and haloes. I successively wore monovision gas perm. contacts for years up until about three years ago when the difference became too much of a sacrifice in both near and distance vision. Since then I’ve worn glasses which I haven’t done for many years (I’m told my eyes are healthy other than cataracts). This makes the option of a monofocal IOL seem a good choice too, except it would be a beautiful thing not to wear glasses except for maybe small print or low light conditions. If the glare isn’t too bad, I think it may be a good trade off for no corrective lenses for the first time since I was 8 years old (currently 63). In your posts I see still other options like Nanoflex and SofTec HD.
What would be your recommendation?
Dennis,
Although I cannot give a specific recommendation as this requires having far more knowledge about your eyes than I have available (or even could have available without an exam), I can state that most people who have done well with monovision also tend to do well with “blended vision” using the Staar Nanoflex or LensTec SofTec HD IOLs. Blended Vision tends to be more forgiving than true monovision in terms of one’s ability to tolerate the difference between eyes. However, the near focus point of Blended Vision is not as close as that of traditional monovision so “readers” may be necessary for small or low contrast print (especially in low light situations) closer than 16-18 inches from the eyes.
Thank you doctor for your prompt reply; I certainly understand your point regarding the necessity of a thorough exam in order to give a professional opinion. I believe the “blended term” you mention signifies something much like monovision with contact lenses. Are the Nanoflex and SofTec HD monofocal or multifocal lenses? If they are multifocal, do they have the side affect of some glare and halos around lights? Also I believe I’ve read the SofTec HD utilizes a somewhat controversial blue light blocking material. Can you shed any light on that issue? My dilemma centers around finding the best compromise of satisfactory acuity with the least dependence on the need for glasses. Can you provide a general opinion on that? One final question; can you address the pros and cons of acrylic vs. silicone materials? Thank you for your help and for your informative web forum.
I’m afraid you’ve got more questions than I can adequately answer in a single comment post. Let me work on creating a separate post to address each of these as I believe others share your concerns.
re: “With regard to the AMO Synchrony, however, you are in good company in your inability to get a “read” on the FDA approval horizon.”
The company told me the FDA wants more data so they are just now starting to plan a new clinical trial which likely won’t even start for a few months so the lens won’t be approved anytime soon. Unfortunately with a rapidly developing cataract I won’t be able to wait for the FDA to approve anything new.
The current trial plan is for the Synchrony to be randomized with a monofocal so those who join the trial may not get it. They say its a newer version of the lens with some improvement for near vision, but wouldn’t give more details.
They also doubted the trial would have one in a power for my high myopia (around -9 and -6.5). I’m still in my forties so it may be worth a bit of non-US travel to get a lens I may use for decades. Unfortunately a poster elsewhere seemed to think even the current non-US version is only available for up to -3 or -4 diopters or so of myopia. I don’t know if it would be viable to get it and then have LASIK to finish correct the remaining -5 or -6 or so diopters, or if that is too much and I should likely consider other options.
Unfortunately in an article I just saw about the FineVision multifocal
http://bmctoday.net/crstodayeurope/2011/12/supplement/
some surgeons were saying they felt high myopia was a contraindication for multifocals, which is the first I’ve seen of that concern. I haven’t seen any research or discussion of that issue elsewhere yet to know how strong their case is.
I develop software and do most of my reading on a computer so I’m more interested in intermediate&distance vision than near which is why the Synchrony sounds interesting. I’ve worn correction for decades (multifocal contacts now, which I prefer to monovision) so its not a big deal if I continue to need it, but it’d be nice if I didn’t.
I have had a non-correctable with prescription glasses cataract in my left eye for the last 2 years. Since I have been very fortunate (and spoiled by) not wearing glasses for more than 64 years, I have been interested in the accommodating IOL as my eventual solution. The Synchrony looked the most promising, but I have not been able to get a “read” on when it will be approved by the FDA. I’d also be interested in your thoughts on the viability of Synchrony technology and what other advances are on the near horizon.
Enjoy your posts and responses to questions. Very objective, clearly written and easy for the non-medically trained to understand.
Thank you David,
I’m glad to hear that you feel my posts and responses are objective and clearly written for those who do not have a medical background – those are my goals and it is not always easy to “translate” the medical jargon.
You have, indeed, been fortunate if you have not had to wear glasses for over 64 years! It would be great if that continued to be the case for the rest of your life. It may be possible with the currently available IOL options (given the caveats I’ve mentioned in other posts and comments). With regard to the AMO Synchrony, however, you are in good company in your inability to get a “read” on the FDA approval horizon. In late 2011 it appeared that it might receive approval in early to mid-2012. Clearly that didn’t happen. My take on the AMO Synchrony is that either the results have not impressed the FDA or the safety issues are concerning the regulators in some way. This could just be a result of the fact that it is brand new technology or that it really doesn’t perform in an impressive and reliable manner. Unfortunately, we won’t know until the FDA “sings.”
After having thought it through, I have decided to either have a regular monofocal or a Nanoflex lens installed. I could not find a surgeon in my area with experience with the Softec HD lens. Once my right eye is operated on, I will get several powers of contacts for my left eye to see if or how much of monovision I would like or can stand. I wish I could wait 10 years for the next generation of IOL technology. I am uncomfortable with the state of premium lenses at this time. Not enough history behind them, they have brought out 3 or 4 versions of each over the last 10 years to make “improvements” and the historicall results are very short term relative to the length of time I will need the lenses to function properly. The monofocal with some level of monovision is “tried and true” and will meet my desire to be able to see intermediate out to distance if all goes as planned. I don’t mind wearing glasses for the rest of my life if needed anyway.
Dr David, you are one of the few sources of information on the Nanoflex that I have found. Thanks for your help. Here are my last questions before I decide.
1) I have read the the Crystalens can “slip” out of position. In your experience, has the Nanoflex shifted position and cause problems since it has the same general shape as the Crystalens?
2) I have read that as the eye heals around the Crystalens or after YAG laser treatment for opacification, the lens has less “accomodation”. Is this a similar result with the Nanoflex?
3) Since the Nanoflex is approved only as a monofocal but has demonstrated a little bit of accommodation, why is mini monovision (-1 to -1.5D) the prefered setting of the non dominant eye vs a more aggressive full monovision (-1.5 to -2.5D or greater) recommended even if the patient could tolerate it?
4) The standard monofocals such as the acrylic AcrySof IQ, have lots of historical results to evaluate. What issues have you seen in long term Nanoflex or in general the Collamer or collogen based lens implant patients?
Once again, Thanks in advance!
All good questions Chris,
I’ve reposted your questions with my answers immediately following:
Question: I have read the the Crystalens can “slip” out of position. In your experience, has the Nanoflex shifted position and cause problems since it has the same general shape as the Crystalens?
Answer: All lenses can “slip” out of position with time. How much they slip and how bothersome this can be depends on the surgical IOL material, surgical technique, and refractive type of IOL.
- IOL Material can result in more aggressive scarring of the capsule which can then result in movement or distortion of the lens. In the case of the Crystalens, the IOL is prone to distortion with aggressive capsular contraction. I’ve not seen “Z-syndromes” or “U-syndromes” with the Nanoflex, but I have seen the single plate haptic IOLs moved aside by capsular scarring.
- Surgical technique is probably more important than IOL material. If the capsulorrhexis is created to fully overlap the optic of the IOL and the lens epithelial cells are polished off the capsule then the risk of IOL displacement is minimized for the following reasons. (1) When the capsule fully overlaps the optic even with significant scarring the capsular forces on the IOL will be symmetric. If there is only partial overlap then the anterior and posterior capsule can fuse essentially pushing the IOL to one side. (2) By polishing the capsule the surgeon is removing the cells that cause the scarring responsible for IOL movement – remove the cells and remove the cause of the problem. Unfortunately, not all surgeons take this extra step as it requires extra time and skill to perform.
- Refractive type of IOL will determine how “sensitive” an IOL is to decentration. Older style spherical monofocal IOLs were very forgiving. I have some patients who had cataract surgery long before I began practice with IOLs so decentered that the edge of the optic is visible through the undilated pupil – yet they have excellent vision. Not so with the newer aspheric and multifocal IOLs. Although these IOLs can provide advantages over spherical IOLs when perfectly centered, as these IOLs decenter the quality of vision is dramatically reduced.
Question: I have read that as the eye heals around the Crystalens or after YAG laser treatment for opacification, the lens has less “accomodation”. Is this a similar result with the Nanoflex?
Answer: In theory this could be a problem for any pseudoaccommodating IOL. Aggressive capsular scarring should be avoided by the techniques described above. With YAG capsulotomies the goal with these IOLs is to make the opening big enough to clear the visual axis but small enough that the vitreous gel does not “prolapse” around the optic. As one potential mechanism of pseudoaccommodation is related to vitreous pressure on the back of the IOL it would make sense that if the vitrous is allowed to push around the IOL (rather than on it) that the pseudoaccommodative effect would be lost (or at least reduced). I’ve not personally seen this problem with my Nanoflex patients as I both polish the lens epithelial cells and make small YAG openings (when needed) whenever I have used this IOL. I would imagine, however, that the Nanoflex could be prone to the same “loss of pseudoaccommodation” issues as the Crystalens. That being said, it’s far less disappointing when this happens with the Nanoflex IOL as the patient has paid $1,100 less for “refractive cataract surgery” with each Nanoflex compared to the same surgery with the Crystalens.
Question: Since the Nanoflex is approved only as a monofocal but has demonstrated a little bit of accommodation, why is mini monovision (-1 to -1.5D) the prefered setting of the non dominant eye vs a more aggressive full monovision (-1.5 to -2.5D or greater) recommended even if the patient could tolerate it?
Answer: Because,
(1) It is difficult to properly test patients with cataracts for tolerability of monovision prior to surgery. By definition, anyone with a significant cataract is going to have a visual impairment limiting their vision prior to surgery. If a patient of mine tolerates a trial of full monovision prior to surgery how do I know s/he will still tolerate it after surgery when the vision is clear? The brain has the ability to essentially suppress the vision from the more blurred eye so did the patient really “tolerate” the trial or was there just suppression during the pre-operative testing? I have no way of knowing – if I’m wrong I could end up with a very unhappy patient after surgery and an IOL exchange is no fun. Almost everyone tolerates mini-monovision so the testing (which is of limited value anyway) is not necessary to predict a satisfactory outcome.
(2) By targeting the intermediate distance in the “near” eye (generally in the range of -0.75 to -1.25) the patient potentially benefits from a fuller range of vision after surgery. This assumes, of course, that the IOL actually pseudoaccommodates enough to result in some near vision also. With full monovision, however, there is often no functional intermediate vision (which in this age of computers can be exceedingly frustrating). Thus, mini-monovision with a pseudoaccommodating IOL has the potential to give a fuller range of vision than full monovsion with a standard monofocal IOL. It should be noted (and I believe I have mentioned this in the past) that most surgeons that implant the Crystalens also target mini-monovision.
Question: The standard monofocals such as the acrylic AcrySof IQ, have lots of historical results to evaluate. What issues have you seen in long term Nanoflex or in general the Collamer or collogen based lens implant patients?
Answer: I’ve been using the Collamer-based IOLs for over a decade and found them to be very stable in appearance and function. I am not aware of any “issues” with this material. However, even the most popular material in the USA (Alcon’s hydrophobic acrylic) is not without material issues – a small percentage of patients with this IOL will develop “opacifications” in or on the IOL that can be seen by the ophthalmologist (but apparently are not noticed by the patient). What science has produced to date is pretty amazing, but it still pales in comparison to the natural lens.
Thank you for the quick reply!
I just saw a second eye surgeon (I decided to get 2 opinions before surgery rather then after) and he indicated that I could esentially have any IOL I wanted since my eyes are healthy, normal and the corneal astigmatism is fairly low. This practice does use the Nanoflex and I asked him about them. He said that the Crystalens has better optics and since I am willing to pay for a premium lens, I should go for the best since I will be using them for the next 30 years or more. I am not sure it is worth the extra dollars since the other feature I like about the Nanoflex is that it blocks UV. He also mentioned the Restore lens, but I would rather see from the end of my arm out without glasses. So here are my new questions:
1) This particular surgeon has only been implanting IOLs for 2 years on has only done a couple of dozen eyes with the Crystalens. Is the Crystalens AO more complicated of an IOL to install then the Nanoflex?
2) This surgeon said that the Nanoflex is more suceptable to opacification (sp?) and requires YAG more often then the Crystalens. Is that your experience?
3) I look at both the Crystalens and the Nanoflex as glorified monofocals that may accommodate for me if I am lucky. The common approach is to implant either of these as mini-monovision resulting in only fair near visual accuity. Will the store bought readers allow me to have stereo vison for up close work like repairing a circuit board or threading a needle?
4) Are the Crystalens optics better?
You’re welcome Chris,
Getting a second opinion is often a good idea prior to making a decision about surgery. You are fortunate to have healthy eyes that allow for many options. The downside, of course, is that with many options comes much confusion. I will try to address your questions below:
First, you need to separate the idea of the lens technology and the “refractive package” being provided by the surgeon. The two are really separate (though interdependent). Think about it as you would modifying your car: there is both the cost of the part as well as the payment for the skills and additional work involved in the customization. Successful “refractive cataract surgery” (which is what cataract surgery is considered whenever the goal is to acheive good vision without spectacles) requires additional testing, skill, techniques, instruments (which can be very expensive), time, and (sometimes) even additional surgery beyond that required for “standard” cataract surgery. These “additionals” are refractive in nature and therefore not covered by Medicare or most Commercial Insurances. Thus, the fee for “blended vision” (with either the Staar Nanoflex or Crystalens) can generally be broken down into a “surgeon’s fee” and “IOL fee.” One of the benefits of choosing the Staar Nanoflex over the Crystalens is that the patient ends up paying only for the surgeon’s fee as there is no additional fee for the IOL (Medicare and most Commercial Insurances will cover the entire fee for the Staar Nanoflex, but not for the Crystalens IOL). This results in a savings of over $2,000 when both eyes are done. Not a bad deal!
1) The Crystalens is objectively one of the most difficult IOLs to insert and position. In addition, in order to function properly it must be perfectly positioned. However, even with a “perfect” surgery the lens may not work as intended depending on how the body heals around the IOL.
2) Both the Crystalens and Staar Nanoflex can be prone to opacification. However, in my experience (supported by my conversations with other surgeons experienced in using either the Crystalens or Staar Nanoflex IOLs), thorough polishing of both the anterior and posterior capsule (removing lens epithelial cells which are thought to be the cause of opacification) greatly reduces the incidence of opacification. The technique required to removed these cells, however, requires a level of skill that not all surgeons posess.
3) I think you’re view of these IOLs is conservative, but not entirely inaccurate. Both require a form of “mini-monovisoin” in order to achieve a truly satisfactory range of spectacle-independent vision. Even with these IOLs, very close work or small print may require either prescription (ideal) or store bought readers.
4) Are the optics of one IOL better than the other? Well, it will depend on who you ask. If you read each company’s marketing materials you will come away befuddled as they both suggest that their optics are superior. How can this be? Well, consider (again) cars. Which auto make is better: BMW or Mercedes? If you had asked Steve Jobs, he would have told you that he preferred Mercedes to BMW. And, he would have a list of very objective reasons that many would agree with. However, there are an equal number of objective (as well as subjective) reasons that could be given to support BMW as the better automobile. The key to understanding this dilemna is that the criteria being used is different for each make. In other words, the metrics, testing, criteria used to support statements of “best” are different for each make. The same is true of IOLs: the determination of “best” depends upon what criteria is used to suggest that one material has better optics than the other.
Bottom line is that pretty much all IOLs on the market today have excellent optics. The differences are subtle, at best. What makes the Softec HD, Staar Nanoflex, and Crystalens different is their pseudoaccommodative effect, not the quality of the optics. One caveat, however, is that most of the surgeons I speak with (myself included) feel that the “Crystalens HD” is a failed attempt at increasing the range of uncorrected vision. The Crystalens line of IOLs are already very persnikety and demanding IOLs to begin with (the “HD” model could stand for “Highly Demanding” in the minds of many cataract surgeons). For those patients who absolutely desire a Crystalens IOL, the model I now recommend is the “AO” (which does seem to be an improvement over prior models).
These posts are great!!
I am 53 and have a mature cataract in my right eye that formed over the last 14 months. My left eye is just begining to get a cataract. I have been near sighted all my life with astigmatism. The doctor said my right eye has 0.8 and my left has 1.1 – 1.2 astigmatism.
I have been studing up on my options and think that the Staar Nanoflex and possibly blended vision is what I would like to try if possible. I discounted the multifocals because of the night halos and glare. I considered the Crystalens but figured that I would probably end up with glasses anyway based on results I have read about. I was also concerned that it is a hard lens to replace if needed.
Here are my questions:
1) Is the Nanoflex easier then most IOL’s to remove and replace at a later date if needed or when significantly better IOL technology comes along?
2) With incisions or laser treatment, what are the chances of having the astigmatism correct for the Nanoflex to work well at distance without glasses?
3)My doctor wants to do both eyes within a month of each other, but my right eye is still working with glasses. Is it recommended to have both eyes done now or should I have one done and just count on wearing glasses until my other eye really needs it?
4) Could I test the blended vision concept for a while with custom prescription glasses after my right eye is upgraded with the Nanoflex for distance and before my left eye is operated on?
Chris,
Glad you like the posts. With regard to your questions:
1) The Nanoflex IOL is made from a pretty soft material so (in that sense) it would be easier to remove from the eye than a harder acrylic material (such as that used in the AMO Sensar). However, I would not recommend choosing an IOL with the idea that it can be easily replaced at a later date when technology improves. Lens exchange surgery is significantly more challenging than is cataract surgery. In general, I recommend choosing an IOL with the anticipation that it will be “for life.” That being said, I cannot personally recall ever having to remove a Staar IOL whereas I have had to explant a few multifocal IOLs.
2) Incisional treatment of astigmatism is pretty good for astigmatism under 1.5 diopters. Beyond that I prefer laser refractive surgery or a toric IOL.
3) The decision to go with surgery on the second eye cannot truly be made until the first cataract has been addressed. Nevertheless, most surgeons (including myself) prefer to anticipate when surgery on the second eye might be done as it can change our IOL recommendations. For example, someone with high myopia (nearsightedness) may not tolerate the difference in refractive error between eyes when one eye has had surgery and the other eye still has a cataract. In such situations (and assuming the second eye has a “visually significant” cataract), many surgeons will recommend going ahead with surgery on the second eye within a month of completing surgery on the first eye.
4) Blended vision (a modified version of monovision) cannot be effectively tested with spectacles – a contact lens trial is required. This can be a problem for someone with cataracts considering true “monovision” because the vision is already limited by the cataract. How, then, does one know if s/he could tolerate full monovision after cataract surgery? Fortunately, it is rare for someone to have difficulty with “blended vision” using a combination of “mini-monovision” and an IOL (such as the Staar Nanoflex or SofTec HD) that has some “pseudoaccommodative” effect. This is because the refractive difference between the two eyes is generally targeted to be only 0.75-1.50 diopters – a difference that is generally too small to result in significant image size disparity with spectacles.
Hope these answers helped to clarify these issues for you.
Greetings again Dr. David, it has been a while. I have abandoned contacts and now get by with glasses corrected for distance and various over the counter reading glasses to kind of handle near vision. The examining optometrist I visited last week tells me that my cataracts show signs that they will worsen rapidly in the near future and he can do little to improve my glasses (I believe he said the cataracts showed signs of sugar crystals and water blisters, if that makes any sense). He recommends that I go ahead with mono-fit Technis lens corrected slightly toward the mid-range, relying on glasses for each extreme.
The Synchrony, were it available, would seem to be a better choice for covering distance to close mid-range and occasional reading glasses for very close up work. At this stage, I am uncertain how far into 2012 I can get before things get really bad with my cataracts.
How long after the Synchrony is approved will it be before surgeons will become experienced enough to allow one to be confident in their ability to implant the Synchrony and approach a result that mostly achieves the potential of that lens?
Hopefully the FDA will approve the Synchrony in 2012 (that’s at least the expectation). As I’ve mentioned on other posts the Staar Nanoflex and Softec HD can provide some range of vision for those who cannot wait and are either not interested or are poor candidates for the Crystalens or multifocal IOLs.
What is holding up the FDA approval of the Synchrony IOL? Is it the manufacturer not pushing it for marketing reasons or because there are issues with the product. Or is it just the FDA being slow. The Synchrony IOL has gained European CE mark of approval years ago and is being implanted there. Should I consider a trip to Europe to get it implanted? If so, can you recommend a competent surgeon in Europe that I should consider?
There is little marketing or financial benefit to be had by delaying the approval of any medical device. In the case of the Synchrony the company (AMO) has purchased the technology and is unable to see any financial benefit in the US until the FDA approves it. In general, the FDA is to blame for delays in US patients benefiting from new technology. In the FDA’s defense, however, there simply is not enough funding for them to move very fast. They are responsible for the safety of the American public with regard to medical devices and medications and have, to date, protected Americans far better then the European counterparts. Nevertheless, it is frustrating when a device that appears to be safe and has been used over seas is unavailable here.
Rumor has it that FDA approval is likely in 2012 (hopefully the first half), so I wouldn’t jet off to another country unless the need for cataract surgery is urgent.
I had a cataract evaluation recently where the surgeon recommended an aspheric tecnis IOL. This is a non-accomodating lens. I asked about the crystalens, and he said in his experience they don’t work that well. My question is, on a non-accommodating lens, how much near focus is lost? I know distance vision is usually good, but what about near vision? Is it blurry at arms length? Less? More? And what is your opinion of this IOL? Thanks.
The simple answer is that one should not expect any significant near vision from a non-accommodating IOL. That being said some people do achieve a level of intermediate vision (though this should not be expected). How much achieved is quite variable and unpredictable. Some non-accommodating IOLs, however, do seem to provide a better range of vision than others. Both the Staar Nanoflex and LensTec SofTec HD provide a larger range of uncorrected vision in my experience. To achieve that range, however, any pre-existing corneal astigmatism must be corrected either at the time of surgery or at a later date.
Bottom line is that anyone expecting to be free of spectacles for any distance after cataract surgery should not expect to achieve this with a standard non-toric, mono-focal (non-accommodating) IOL. Yes, there are some people who have minimal corneal astigmatism who are able to go without spectacles for distance and some intermediate tasks after standard cataract surgery with an insurance-covered IOL. They are fortunate. They are the exception.
With regard to my thoughts on the AMO Tecnis, it is a quality mono-focal IOL with which I have had good results in patients who do not mind wearing glasses for all distances. I would not recommend it (or any hydrophobic acrylic IOL) to patients who desire a range of uncorrected vision as that is simply not a realistic expectation for most patients.
Side note with regard to the Crystalens IOL. I agree with your surgeon that the Crystalens is a difficult IOL to use. Hitting the refractive target requires meticulous surgery as well as a predictable healing response – which neither the patient nor doctor have much control over. I am now recommending to those patients of mine who desire a range of vision without glasses (and who do not want the rings associated with a multifocal IOL) that they either (1) wait for the AMO Synchrony to be FDA approved, or (2) choose “blended vision” with either the Nanoflex or SofTec IOL.
Almost a year ago, you suggested to Ms. Blackburn that she may want to wait until the next generation of IOLs arrive in 2011 or 2012 before replacing her lenses…. my eyes/age are also similar to hers… 55 years old, farsighted, no cataracts (but one eye much worse than the other… we are considering just doing this eye). Any progress worth noting in the next generation? My eye doc is suggesting the ReSTORE….but I’m willing to wait a bit to guard against halo risks. Glasses are working fine, I just don’t like the thick lens and awful sight in one eye.
Thanks much.
Unfortunately, the AMO Synchrony is probably not going to be approved for use in the USA until 2012 at the earliest. The only new pseudo-accommodating IOL likely to be approved in the US anytime soon is the Tetraflex IOL which, in my opinion, warrants little more than a “yawn.” Of interest is that many surgeons are having success using IOLs such as the Staar Nanoflex with “mini-monovision” or “blended vision” to achieve an impressive level of spectacle independence without the halos noted with multifocal IOLs.
Is this not the age of biotechnology??? Are new “living” human lenses being grown in test tubes or petri plates or something to be implanted within the cleaned capsules rather than “none living” IOLs??
Afterall, new organs such as bladders are grown up and transplanted in humans, just where are the human lenses???? Human lenses should be easy compared to human bladders.
Why are you MDs holding up progress with these weirdo IOLs when mother nature made the original lenses that we all know and love??? We just want to replace mother nature’s foggy and stiff lenses with flexible and clear lenses.
We want human tissue lenses, grown from our very own human lenses to be termed, “autohumantissuegrowninvitro lenses” for implantation into our cleaned capsules.
Who is doing the research on “autohumantissuegrowninvitro lenses”????
You’re funny. Clearly, you have no real understanding of what is going on with lens replacement research. Fist of all, it is not doctors who are holding up progress in researching human tissue IOLs, as most of the research is being done by MDs. The hold up is that the most promising tissue for replacement is human embryonic tissue which has severe restrictions on its use in research (at least in the USA). Regarding the current IOL materials, they are nothing short of amazing when one considers the progress that has been made in the last 50 years. Take a moment and think of the following before your next rant about “holding up progress.” For all of human history up until the last fifty years, the development of cataracts meant certain blindness. Now, however, cataract surgery with man-made IOLs not only cures the condition, but leaves many people with better vision than they ever experienced before in their lives. Natural does not always mean better.
Is capsular contraction and/or lens decentration more common in young patients with PSC cataracts?
In general younger patients tend to have a more aggressive healing response. Also important is how well ones surgeon “cleans up” the capsular bag. As the bag is so delicate, not all surgeons polish it as I do with each case. However, I have noted a significant decrease in capsular contraction since I have been routinely polishing the capsule.
On May 22, 2010 you stated that Synchrony has met with less than stellar initial clinical results. What exactly are they encountering?
On July 6, 2010, you stated that the Synchrony is a bulky lens that requires a larger incision than the Tecnis multifocal which requires less than 2.8 mm.
Synchrony comes in a pre-loaded injector designed to be implanted through a 3.8 mm incision. Visiogen, Inc. is actively working on an injector system that will allow the lens to be delivered through a significantly smaller incision.
Do you have any information on what Visiogen, Inc. might achieve?
Hi Dr Richardson,
Do you have any idea when the Synchrony IOL might get approved by the FDA? Is it correct that that this lens requires a very precise Capsulorhexis which might be more easily done with the new femtosecond lasers?
Unfortunately, we will probably not see this IOL being used in the USA until 2012 (though we can hope for late 2011). Also unfortunate is that you are correct about the capsulorrhexis. Like the Crystalens, the Synchrony appears to be sensitive to the size and shape of the capsulorrhexis. As the femtosecond laser is VERY expensive (and used by only a handful of surgeons), most people choosing either of these IOLs should opt to have their surgery performed by experienced surgeons (who have better control over the size and shape of the capsulorrhexis).
Hi
I have followed the conversation about IOL’s with interest and it seems the perfect solution is still a way off.
My question is simple.
I am 56 years old and long sighted to a degree that makes laser surgery impossible and means I must wear contact lenses + reading glasses or varifocal glasses at all times. That said, I do both with a reasonable degree of success aside from the usual inconveniences of having multiple pairs of spectacles and some aversion to bright light when wearing contacts. Would you recommend surgery to fit IOL’s at this time or would I be risking the poor but externally correctable sight I have for an outcome that may not be much better – could even be worse- and spending quite a lot of money to do so??
I would say that based on the currently available technology you have answered your own question with the statement: “That said, I do both with a reasonable degree of success aside from the usual inconveniences of having multiple pairs of spectacles…” Although I have been impressed with the currently available multifocal IOLs, it is difficult for me to recommend them to anyone without cataracts at this time simply because they do result in small circles around lights at night. Now, for someone who is used to the glare associated with cataracts, this residual halo is often an acceptable price to pay for the overall improvement in vision. For someone who otherwise can achieve clear vision with contact lenses or spectacles, these little rings can be unpredictably bothersome.
Some more aggressive surgeons might offer the option of a Crystalens IOL as rings around lights are generally not seen with this IOL. However, if, by “long sighted” you mean farsighted, this IOL would not give you a full range of uncorrected vision secondary to the anatomy of your eye.
Bottom line: if you are doing OK with your current means of correction I would advise waiting until the next generation of IOLs hits the US market in 2011 or 2012.
Could the 3 dimensional nature of the dual optic design help prevent collapse of the lens capsule? At least one study has found it to have stable accommodation over the course of a 5 year study implying that the mechanism of accommodation continued to have space within the capsule to adjust the lens positions along the z-axis. Does it depend on a certain amount of capsule contraction in the x,y plane to stabilize the lens structure within the capsule or does it experience drift within the capsule?
Would a capsule filling design, dual optic or gel, justify its “bulk” in some way? Could improvements allow them to be implanted through competitively small incisions?
Unfortunately none of us will live long enough to receive the “perfect” technology and we must choose between those available when our own circumstances demand a decision. I wholeheartedly agree that when my moment comes, and that will be sooner rather than later, I intend to find the physician most accomplished at reaching a good outcome, which cannot be anyone nearby since I live in a small community. Having gotten by with the mono-fit contact lens for years I do hope to achieve two eyes that can again cooperatively focus at the same distance, including intermediate distances, if that is possible. The fact that multi-focal contacts have never been advanced by my optometrists as a good solution makes me very wary of multi-focal implants. A sister currently dealing with a possibly decentralized multi-focal lens implant (that I did not discourage) has only made me doubly cautious.
I greatly appreciate your candor and willingness to discuss the issues that new patients might have to confront. And the level of technicality has not been over my head at all which I also appreciate. I will not continue to pepper you with questions beyond this note. You have been more generous that I had any right to expect. Thanks again.
Your logic is sound. Indeed, it is widely believed among ophthalmologists that the “ideal” IOL will be a “smart” gel-like substance which can be injected through a 1mm or smaller incision and fill the capsular bag just as the natural lens does in a young, healthy eye. To date the technical limitations have been the need to create a 5-6mm capsulorrhexis and the lack of a “smart” material. However, the Femtosecond laser may be the technology that allows the creation of a sub-1mm opening in the capsule and there are already companies researching acrylic designs that are rod shaped at room temperature but assume a disc shape at body temperature.
Don’t be too sure that you won’t see the benefits of this technology during your lifetime. The competition to create an IOL that replicates the function of a 20 year old emmetropic eye is fierce and there are hundreds of millions of dollars being invested in achieving this goal.
It is a very exciting time for anyone who will be considering cataract surgery in the next decade. Up until now, the compromises have been taxing (glare, limited range of vision, poor reproducibility, etc.). The Alcon ReSTOR +3 and AMO Tecnis Multifocal IOLs represent the first generation of multifocal IOLs that are reliable, give a near-full range of vision, and have minimal side effects (the halos really are nowhere near as significant as the earlier ReZoom and ReSTOR +4 IOLs). With the addition of the AMO Synchrony IOL, anyone desiring a near-full range of uncorrected vision will have an appropriate IOL to choose from. Yes, there will still be limitations, but compared to always needing readers or bifocals, the technology available in the near future will be more benefit than limitation.
I can’t wait to see what comes next. And, I promise to keep you and other readers of my blog up to date as I hear about the latest advances in IOL technology.
First, Dr. Richardson, thank you for taking the time to reply to my lengthy question. Is the necessary centering of the multifocal type lens more critical than in dual 0ptic or single optic psuedo-accomodating lens. Thus, does relocation of the lens within the capsule become a less likely and/or less important event for the different types of lens. Has the frequency of Yag laser capsulectomies lessened with the latest generation of ReStor or ReZoom or CrystaLens and how do these rates compare to the Synchrony results so far? I believe the early CrystaLens models had trouble with this and I have read several anecdotal reports for the presumably earlier ReStor and ReZoom. I raise none of these points for argumentation purposes but simply want more information. I think all of us feel our eyes are critical to the quality of the remainder of our lives.
Michael,
You are correct that centering is critical when implanting the multifocal IOLs. Additionally, aspheric IOLs (both mono-focal and multifocal) quickly lose their advantage as the IOL decenters. Fortunately, the modern single-piece acrylic IOLs center very well with minimal manipulation. The surface of either the AMO Tecnis multifocal or Alcon ReSTOR is a bit “tacky” resulting in good stability after surgery. With proper intraoperative cortical clean-up combined with the acrylic IOL edges designed to minimize posterior capsular opacification, an aggressive capsule contraction can usually be avoided.
Although one could argue that centration may be less critical with the pseudo-accommodating IOLs, these lenses suffer from positional challenges that are more difficult to control: anterior-posterior displacement and tilt. Hopefully, the dual-optic IOLs will solve the anterior-posterior (or Z-axis) issues by fully expanding the capsular bag. The Crystalens, however, has been plagued by progressive anterior displacement after surgery resulting in myopic (nearsighted) shifts after surgery in some eyes. This is exacerbated by the lens material chosen for the Crystalens: silicon. Silicon IOLs are extremely flexible, but have some downsides including a more aggressive capsular response which can lead to displacement of the IOL in any axis. Indeed, one of the most feared complications of the Crystalens is what is called “Z-syndrome” which was supposedly resolved with the “5-0″ platform (though I as well as other surgeons soon found out this was only wishful thinking). So why do surgeons (including myself) implant this lens when it has so many potential downsides? Because not everyone is a good candidate for a multifocal IOL and there are surgical techniques one can use to minimize the risks of capsular contraction.
Without getting too technical, there are a few factors that can be controlled by the surgeon which are probably more important than IOL material. (1) creation of a well-centered capsulorrhexis with edges overlying the multifocal optic (no one really knows what is best for the Crystalens – recommendations seem to change with each season); (2) maintaining the integrity of the capsular bag (avoiding tears); (3) meticulous cortical clean up – I personally believe this is difficult to achieve using a “coaxial” irrigation and aspiration (I&A) hand piece which is why I use a bi-manual set; (4) excellent zonular support limits capsular contraction (which is why I implant a capsular tension ring “CTR” in every patient in whom I implant a Premium IOL); (5) complete removal of the viscoelastic gel allowing contact between the IOL and posterior capsule to “fix” the lens in place; (6) maintaining a stable anterior chamber after surgery (which is why I also place a suture in every patient in whom I implant a Premium IOL). These are my preferences and I am certain there are very adept surgeons who would disagree with the need to use bi-manual I&A, CTRs, and sutures in every Premium IOL patient.
I hope this illustrates that as important as researching the available IOL options (indeed, possibly more important) is researching one’s surgeon. I’m not suggesting that you interrogate a cataract surgeon about the type of I&A instruments s/he uses, but experience does matter. One final note: if a surgeon states s/he has not had any of the less than desired outcomes of any of the available IOLs, that does not necessarily mean that s/he is a great surgeon. It could also be an indication that s/he simply has not implanted enough of a particular IOL to experience these adverse results. One mark of a good surgeon is how s/he deals with an adverse outcome. One must experience these outcomes in order to gain the knowledge necessary to deal with them. Numbers matter. The more surgeries completed, the better…
You say that Synchrony has underwhelming performance but the only generally available (on the web) studies indicate that they or relatively free of glare, have superior contrast, low capsule opacification rates, generally consistent accomodation over several years and accomodation that averages about 3 diopters and does not seem vary much from individual to individual. Reading rates are about the same as the Technis which considered superior in this category. Are your observations based on results developed in the fda clinical trials that have not yet been published or are they available somewhere to be read? Do they suggest that the claims described above are not representative of typical recipients’ experience with this new iol?
All good points. There is no question that compared to the only other available pseudo-accommodating IOL on the US market (the Crystalens), that the Synchrony has promise. That being said, the goal is moving. You compare the Synchrony results to the AMO Tecnis multifocal IOL which is a fine piece of engineering. Nevertheless, from the Surgeon’s perspective, the Syncrony is going to have to prove itself to be a significantly better performer than either the Tecnis multifocal IOL or the Alcon ReSTOR +3 aspheric IOL. Both of these are significant improvements over earlier multifocal IOLs such as the ReZoom or non-aspheric ReSTOR +4. Halos around lights are less bothersome with the newer multifocals and the incision size is small (less than 2.8mm for the Tecnis multifocal and 2.2-2.4mm for the ReSTOR +3). The Synchrony, however, is a bulky lens that requires a larger incision (potentially inducing astigmatism and requiring a suture).
Additionally, the dual-optic and dual-material technologies coming down the pipeline have the potential to provide accommodation ranges far beyond the three diopter ceiling of current technology.
Bottom line: I think the Synchrony is going to make a nice addition to the Premium IOL options available to US patients. I am planning on using it in those patients for whom I would currently recommend the Crystalens. But, I don’t see it taking over Alcon’s ReSTOR +3 as the primary choice of most American surgeons. The ReSTOR +3 is simply too predictable and works too well for a bulky, new technology to overtake it. Yes, we surgeons do love new technology and our toys. However, when it comes to what we recommend to our patients, tried and tested IOLs will always trump newer technology until such time as the newer technology has a proven track record of being superior (both in safety and results) to the more established technology.
Hi. Do you have any updates on the Synchrony or other new IOL’s that has made progress in the last year ?
Unfortunately, the initial excitement of the Synchrony has met with less than stellar initial clinical results. That being said, the game is not over yet. If the refractive outcome is more reliable than the Crystalens and it provides even an extra line of near vision then it will have a place in my practice, at least. At the moment, the only “advanced” IOLs that I am recommending for my patients are the Alcon Toric, Alcon ReSTOR +3, and the Crystalens AO. This could change, however, based on updates to the latest clinical research.
Thanks. I’m really looking forward to this.
So this means, that surgeon don’t know exactly the position the IOL will end up with, and that is the main factor how the result will be ?
The leaked results for Synchrony indicates results from 20/20 – 20/40 for most people. I don’t know how bad 20/40 is, but it doesn’t seem so bad, compared to that other semi-accomodating lens you mentioned in another post. I looked at that lens a month ago, and the results seemed quite bad, from 20/20 to 20/200.
Yes, these initial results are impressive. To give you an idea, someone with 20/40 uncorrected distance vision would be able to obtain a driver’s license in California without spectacles.
The issue with effective lens position (at least for the Synchrony) is that it is a dual optic system with the lenses moving relative to each other. As such, it is difficult to calculate where the lens actually sits in the eye (from the perspective of a ray of light). If the effective lens position (ELP) is more toward the front of the eye (anterior) than anticipated the eye will be myopic (nearsighted); if further toward the back of the eye (posterior) the eye will be hyperopic (farsighted). Without knowing the true ELP a surgeon cannot accurately calculate the proper power to implant in the eye.
The issue of ELP is present for all lenses but is exacerbated by the dual-optic system. Additionally, eyes that are either longer or shorter then average can change the ELP in such a way that the standard lens calculations are thrown off.
David D. Richardson, M.D.
Medical Director
San Gabriel Valley Eye Associates, Inc.
I wasn’t able to see real well the next day either but the flwooling day was really a lot better and I drove to work. You will probably notice a big difference tomorrow. I also go the anti-anxiety in my IV. When the anesthesiologist came in she could see how nervous I was and asked if I wanted her to give me a little something to calm me down. They gave me more after I got back into the room. Didn’t put me out but it did relax me.
I hope you will keep updating on this IOL, as it indeed sounds very interesting.
But how much can we hope for? It looks like it will be the best IOL by far, when it becomes available, but it seems it isn’t being discussed much, at least in public.
And it looks like it doesn’t provide much accomodation (diopters) as the normal eye, so how will that affect vision, will you still need spectacles at near sometimes, and how about medium and distance view ?
What will determine the end result, as it seems it could provide between 1-4 diopters, and some get 20/20 as others get 20/60 ?
And if you get 20/60, will it be correctable by contact lenses or spectacles ?
You can be certain I will have updates on this IOL by April as I will be attending the American Society of Cataract and Refractive Surgery annual meeting in San Francisco. I also agree that it has the potential to leapfrog into the #1 presbyopia correcting IOL once it is released (as did the Crystalens 5-0 when it was approved). However, it will likely share the same challenge that the Crystalens presents to surgeons: figuring out the effective lens position. This could be a topic for an entire post (and I may just do that). In short, it is difficult to choose the correct power IOL without knowing where in the eye it is going to sit. Complex optical systems such as the eye are very sensitive to the relative positions of the individual lenses. That being said, even if the IOL ends up too far forward or back in the eye, glasses would be able to correct this.
David D. Richardson, M.D.
Medical Director
San Gabriel Valley Eye Associates, Inc.