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Round table: Philosophy of mixing IOLs for presbyopia correction spurs debate
OSN convened a panel of refractive surgeons to discuss the merits of using two presbyopia-correcting IOL technologies in the same patient, as opposed to using a single technology in both eyes.
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![James A. Davison [photo]](/~/media/images/shared-images/james-a-davison-photo.jpg)
James A. Davison
Richard L. Lindstrom, MD: Our agenda today is to talk about the appropriateness of combining the current IOLs that are approved for the treatment of presbyopia in the two eyes of one patient. Let me start with a history of “old mixing,” and then we will review the panelists’ opinions on how the currently available lenses should be used.
There is a historical track record of mixing slightly dissimilar IOLs. Most of us, for example, have had experiences in which there might be a silicone IOL implanted in one eye of a patient who previously had a PMMA or foldable acrylic IOL in the other eye, or a foldable acrylic lens in one eye of a patient who had a previous PMMA lens or silicone lens. Also, some of us have had experience doing monovision, and clearly those are somewhat dissimilar optical systems, with one eye focused for distance and the other for near or intermediate.
In addition, most of us have put a monofocal lens in one eye of a patient who has a natural crystalline lens in the other eye. We have also implanted non-aspheric IOLs in one eye and aspheric IOLs in the other eye with reasonably good outcomes. We also have, for example, done blue-blocking IOLs in one eye and a different IOL or a natural lens in the other eye.
There also is a background in contact lens practices, with patients who, for example, have ametropia and have a monofocal contact lens in one eye and a multifocal contact lens in the other, which is generally called modified monovision. Also, dissimilar multifocal contacts are used by some patients.
We performed the early multifocal IOL clinical trials with the 3M diffractive, and with the IOLab, Alcon and Storz lenses. We implanted them in quite a few patients. In the trial protocols, we were allowed to implant only one multifocal lens, so almost all the patients had a monofocal in one eye and a multifocal in the other. I have nearly 20 years’ follow-up on some of these patients, and I can tell you they do well.
With the IOLab lens, which was a somewhat near-dominant lens, when we did the outcomes analysis, both subjective and objective, the outcomes were better in the patients with the monofocal-multifocal combination than they were with bilateral multifocals. As that lens evolved in Europe, most surgeons used it in only one eye in sort of a modified monovision approach, and it worked pretty well. So I am confident that we can do monofocal/multifocal with good success.
But can we mix the current generation of presbyopia-correcting IOLs? These include the accommodating eyeonics crystalens and the current generation of multifocal lenses, the Alcon ReSTOR and Advanced Medical Optics ReZoom.
Differing experiences
Dr. Lindstrom: I will start by describing which implants that we have experience with, and whether we have mixed them in any way with a dissimilar optical system in the other eye. I personally have experience only with the crystalens and the ReZoom. I have implanted a crystalens in one eye with a monofocal lens in the other eye. I have implanted a crystalens in one eye with a natural human lens in the other eye. I have also done a crystalens in one eye and a ReZoom in the other. What is everyone’s experience?
Frank A. Bucci Jr., MD: I started out using the new multifocal lenses. I thought that the ReSTOR lens would be able to solve the problems I experienced with AMO’s earlier version of its multifocal IOL, the Array. I felt that I needed a stronger lens for reading on a consistent basis. I needed less light phenomena at night. The data on ReSTOR appeared to look good.
I am currently following 56 patients with bilateral ReSTORs, and I have other lenses that were used and mixed with ReSTORs. I did experience some problems with intermediate vision with the ReSTOR, which led me to investigate ReZoom and ReSTOR. I have 30 patients with one of each lens and another 15 scheduled, so I will have a cohort of 45 soon. I have good follow-up on 21 of the ReZoom-ReSTORs and 45 of the ReSTOR-ReSTORs, with proper data collection.
Dr. Lindstrom: Have you done ReSTOR in one eye with a monofocal in the other eye, or have you done a unilateral ReSTOR in an eye with a natural lens in the other?
Dr. Bucci: I have five patients who were emmetropic presbyopes preoperatively who are now unilateral ReSTOR patients. Four of five patients are less than happy and report a waxy or 3-D distance and near vision even though they are close to 20/20 and J1. They say it is “just not clear,” and they cannot use the eye to read.
I know they would improve with a ReZoom or ReSTOR in the other eye, but with the emmetropes I am conservative and the initial intent was to stay unilateral for a number of months if not longer. I had great success with unilateral Arrays, so my preference has switched to the ReZoom for unilateral emmetropic presbyopes.
One of the most interesting combinations I have is in patients who had Arrays in only one eye, who wished they were reading better. So I placed a ReSTOR in their other eye, and they are some of the happiest patients I have seen because they finally have the reading that they wanted, and they have intermediate vision from the Array lens.
James A. Davison, MD, FACS: I have four unilateral ReSTOR patients who have normal lenses in their other eyes, and they are all happy. But I am exactly the opposite of Frank. I have not mixed any multifocal IOLs.
Stephen S. Lane, MD: I usually use a ReSTOR lens in one eye and a ReSTOR lens in the other eye, and I also use a ReSTOR lens with a monofocal pseudophakic lens in the second eye. If I have a natural lens in one eye, I use a ReSTOR in the other. I have not mixed ReSTOR with ReZoom.
H.L. Rick Milne III, MD: My experience so far has been with both the ReSTOR and the ReZoom lenses. I have yet to put in a crystalens, but we are leaning toward doing that in the future. I think it actually offers some things that neither one of the other two lenses offers.
Robert P. Lehmann, MD: I have not implanted the crystalens, and I have not implanted the ReZoom yet. I have 51 patients, so that is 102 eyes, from the original Food and Drug Administration clinical study, who are now over 3 years postoperative. Since May 2005, I have implanted another 231 ReSTOR patients. Twelve of these have been unilateral, and eight of those are awaiting their second eye.
I typically implant the second eye pretty quickly, 1 week later, maybe 2 weeks at the most, and I find that by doing so, patients adapt more quickly. But I have had excellent success with bilateral ReSTOR implantation. In the FDA clinical study, 80% of our patients never wear glasses for distance, intermediate or near. In my 51 patients, 90% never wear glasses.
I am doing patients with more cylinder, and a number of those patients are coming to limbal relaxing incisions. But I have done only one LASIK touch-up, when I felt it was absolutely necessary, on all these patients, which is a pretty low number.
Favoring same lens
Dr. Lehmann: I agree with Dr. Lindstrom’s opening statement that we have tried various types of mixing in terms of one silicone with one acrylic or one multipiece with one single-piece. But I do not know that that concept really crosswalks when it comes to presbyopia-correcting technologies. I just do not have the need, to consider mixing and matching because my patients do well with the single technology in both eyes.
I did a dozen patients who have had LASIK in both eyes, and one eye has developed a cataract. I also have had a patient with one ReSTOR eye and a clear crystalline lens in the other, and these people seem to do well if you choose your patients carefully. I think that in that light, if you consider mixing lenses, you might consider the crysta-lens, which in many respects acts more like a monofocal implant. Perhaps the crystalens with the ReSTOR or the crystalens with the ReZoom might be an acceptable option.
But when it comes to mixing the apodized diffractive technology with the zonal aspheric technology, the ReSTOR-ReZoom combination, I have to say, “Show me the data,” because it frightens me.
If you are having great success with ReSTOR, then by all means use ReSTOR. If you are having great success with ReZoom, use ReZoom. But until I see some good, hard scientific data I am reluctant to mix the two.
Dr. Lane: What concerns me about the mixing and matching of the two multifocals, the ReZoom and the ReSTOR, the diffractive and the refractive lens, is the experience that I have had with some patients after LASIK or even after monofocal IOL implantation. That is, even though you do exactly the same thing in both eyes, inevitably patients compare their two eyes. They will say, “What did you do different in this eye that you did not do in this eye?” There is always one eye that the patient feels sees a little bit better, when, in fact, you have done the same thing in both eyes.
I do not want to set myself up for having to come up with an explanation of why they see differently in one eye as compared to the other eye, when I put one lens in one eye and one in the other. That possibility concerns me.
Results with mixing
Dr. Milne: My experience began with doing ReSTOR bilaterally. I put it in more than 50 patients bilaterally. I told those patients they would likely have good near, distance and intermediate vision. In August 2005, I had several patients who were unhappy, having paid a large sum of money, coming back and telling me how disappointed they were with their computer screen distance.
So I began to consider putting the ReZoom in a few patients. I had experience with more than 900 Array patients, so I knew the downside and plus side of the Array. So with some trepidation I put a ReZoom in my first patient. To my surprise they did well at both near and intermediate, much better at near than I thought they would do, and did not have some of the night issues I thought they might have.
Since that time I have more than 60 patients with ReSTOR in one eye and ReZoom in the other eye, and I have found these patients to be doing extremely well. I even did this combination in two patients who I would consider on the high end of most demanding patients. One is a nurse anesthetist I work with all the time, and she is a particular person. Another gentleman I also had great trepidation about, had developed cataracts and needed something done, and he wanted a multifocal lens. These are patients none of us would really want to do surgery on, and both have done so well they are sending everybody they know to see me to have these implants.
I would say, not just anecdotally but with some of the data we are collecting, that people who have the ReSTOR-ReZoom combination like it. I have yet to have one patient who has not been more than happy with their varied visual abilities.
Helping patients understand
Dr. Lindstrom: Let’s talk about patient selection. If a patient comes in, 40 years old with a traumatic cataract, is it OK to use a multifocal lens in that eye? Can we put a multifocal lens in one eye of a patient who has a traumatic cataract in that eye?
Dr. Lane: I have done that in several patients. I have three cases now with exactly that history, and I have put ReSTOR lenses in the cataractous traumatic eye. All three of them love it and are doing marvelously without any trouble. I cannot tell you whether their intermediate vision is coming from their phakic eye or their pseudophakic multifocal eye or both, but they are without complaints and ecstatic.
One man in particular had gone a number of years with cataract and poor vision because of reluctance of a number of surgeons to operate on him. I ended up doing the surgery. He had loose zonules, and I put a capsular tension ring in. The bottom line is that he has done great and has excellent near, distance and intermediate vision.
Dr. Lindstrom: In a 40-year-old pre-presbyopic patient, do you think a multifocal IOL is a better option than a monofocal or an alternative, equivalent option?
Dr. Lane: I think it is a better option, especially as they approach that pre-presbyopic age. This man I just described to you was 42 years old and was not yet wearing reading glasses consistently. He needed them from time to time. He has not had to pick up his readers since he had the lens implanted.
Dr. Lindstrom: What about a Medicare patient who has a 20/60 cataract in one eye but the other eye is still 20/20? It might be 2, 3 or 4 years before we do the second eye. You could offer to do the second eye and have the patient pay for the whole thing themselves. But what if they are 20/20 and the other eye is 20/60? What are you recommending for those patients?
Dr. Bucci: When we had the Array, for instance, we had to explain that there might be halos and their reading might be J2.
You must inform them of what is going to happen. If you say you will be improving their reading vision, you explain their choices, and they choose to do it, then I do not have any objection to it. But you have to prepare patients, manage their expectations and tell them what will be different.
One of the good things about the ReSTOR lens is that it has dramatically fewer halos, in my experience of putting more than 200 of them in, so that is less of an issue, and it widens the scope of patients who can have a multifocal lens.
Options
Dr. Lindstrom: Rick, you did 900 Arrays. Did you do any in this kind of situation, a Medicare patient for whom you may not be doing the second eye for several years?
Dr. Milne: That was something we would come across fairly frequently. What Frank said is key. Even now, I have implanted both the ReSTOR unilaterally and the ReZoom unilaterally in a number of patients, and they are doing well.
My approach with these patients is that I try to listen to what their desires are. I want them to put it on the table, whether they are trying to become spectacle-free as part of what they are trying to accomplish with their cataract surgery. If they want other options, I will tell them that I think their best option is to consider these multifocal lenses.
I also tell them that they will not get the full benefit of these lenses until both eyes have had surgery, and they may notice more the downsides of the lens until both eyes are done.
As Frank said, once patients are informed, an informed patient is a happy patient. A patient who gets a postop surprise, something that you did not tell them about, is an unhappy patient. But by and large these patients do well. They undergo neural adaptation just as well as all our other patients.
I have been impressed with the ReSTOR and the ReZoom as far as nighttime glare issues. Patients do see halos; I tell every patient they are going to see halos, but the complaints are minimal.
Dr. Lindstrom: Less than you had with the Array?
Dr. Milne: Yes, much less, and thankfully so. It has been impressive. It was with some trepidation that I entered back into multifocality because of some of my earlier patients who never adapted to the Array lens. I am now close to 300 eyes, and I have not had any patient with either one of these lenses have a big problem post-operatively with night vision.
Younger patients
Dr. Davison: Rather than the patient who has the 20/60 cataract, the thing I am seeing more commonly now is that younger patients are hearing about the multifocal lenses. So they are the ones that are coming in.
Dr. Lindstrom: The patient with a posterior subcapsular cataract who is 20/30 or so, and with a lot of night glare vision, they fall to 20/70. Are you suggesting this is not a good patient for a multifocal?
Dr. Davison: No, that patient is OK. It is the person who comes in with fairly mild nuclear change, and they say they have a lot of glare. They also say they’ve always had glare and difficulty with night driving. They really want to get the surgery done, and you look at their cataract and you think, “I am not sure I even want to do this cataract.” But they are complaining about their vision. They say, “I have heard of this new technology, and I am really interested in it.”
Dr. Lehmann: I have had patients come in who do not have cataracts and who complain of lifelong glare and want to get the multifocal lens. I typically pass on them for any kind of surgery. But if they have some nuclear opalescence and glare symptoms, I have had excellent success with them.
It goes back to what Frank and Rick were saying. Patient selection is key. For the surgeon who is starting out in this field, they should remember to “pick the low-hanging fruit.” Pick patients they have a good rapport with, to whom they can explain all of the expectations and the limitations, so that patients do not think they are going to be able to see through walls and around corners. If you do that, you can really position yourself for success with these lenses.
Bilateral implantation
Dr. Lindstrom: So once you counsel the patient, and they accept the side effects that might occur, are you going to implant a multifocal IOL in both eyes fairly quickly? Jim, is that your current approach?
Dr. Davison: It is.
Dr. Lindstrom: When do you do the second eye?
Dr. Davison: My usual schedule is 3 weeks apart.
Dr. Lindstrom: What if the patient comes in at 3 weeks and says, “I really do not like this. My intermediate is terrible, and my night vision is terrible.” Do you just advise them to get the second eye done because that will fix it?
Dr. Davison: We have had that discussion with two patients, not because of intermediate vision or night vision problems but because of flashes of light or pseudophakic dysphotopsia and subnormal central vision recovery.
Dr. Lindstrom: Did you have to explant the first IOL before you did anything in the second eye?
Dr. Davison: In those two patients, yes. They are exceptions to the otherwise good recovery of functional vision. Most of these patients get decent intermediate function, and it continues to be my experience that rings and halos are a minor issue, if any, for almost all patients.
Dr. Lindstrom: Rick, you did a series of bilateral ReSTOR IOLs, and now you have done a series of ReZoom-ReSTORs. What prompted you to do that and how it is working? When a new patient comes in, how do you decide what you are going to do?
Dr. Milne: What prompted me was, I had waited for the ReSTOR lens for about 18 months, and I had a waiting list of patients who were waiting for the lens. I found that I had 20% of patients with bilateral ReSTORs were dissatisfied with different issues when the lens was just placed unilaterally.
I decided to try mixing the ReSTOR and the ReZoom. So I decided to do a subset of patients in which I put the ReZoom in the first eye and the ReSTOR in the other eye. That is now my major approach.
Dr. Lindstrom: What do you tell the patient about why you are doing it?
Dr. Milne: Preoperatively, I say, “We have some really nice options in ophthalmology, and we have several lenses to choose from. Each one provides good vision, and with a combination of both we hope to accomplish a better endpoint for you. Each lens has strengths and weaknesses. The two lenses I am choosing are a great combination in that one’s strength is the other’s weakness. What is probably going to happen is, one eye will do better at distance and intermediate, and the other eye will do better for near vision.” Patients seem to understand that.
Of the patients in whom I have implanted both these lenses in the past few months, none of them is asking for me to do anything additional at this point. To me, that is positive.
Dr. Lindstrom: So the ReSTOR-ReZoom combination is your current recommendation to patients?
Dr. Milne: It is my up-front recommendation to each patient, but I will put in a caveat. I listen to what their near vision is, what their near vision world looks like, and I say either, “It sounds like you are going to be a good candidate for the ReSTOR lens,” or, “You are going to be a good candidate for the ReZoom lens.”
Then I say, “We are going to put that lens in your first eye. If that meets all your expectations that you want to accomplish, we will use that lens in both eyes. But if you do not like some of the limitations that I am explaining to you, then we have another option to put a complementary lens in your second eye.”
Dr. Lindstrom: Even when they are happy with their results, do many of them still choose the opposite lens thinking it could be even better?
Dr. Milne: That is right. I think part of it is that I have explained to them the limitations for whichever is the first lens, so they are quicker to key in on that.
Dr. Bucci: I want to reinforce one thing that Rick is saying. He has established a relationship with the patient, and the patient trusts what he says. That is why they are willing to listen to him. That is one of the key things that you have to do. They trust that what he is recommending will work, and he believes it, and he does it.
Which eye to do first
Dr. Davison: Can I pose a question about ocular dominance? It comes in all degrees, so which eye and what kind of IOL do you recommend to do first?
Dr. Milne: In a person who has cataracts, I do not think it matters much. I usually do the worst cataract first, and in that eye I put the lens that is going to accomplish the patient’s most desired near-vision goal. If it is to see the computer screen, they will get the ReZoom, and if it is close vision they will get the ReSTOR.
In a person who is having a clear lens exchange, I go with the dominant eye first. I put the lens that I think will be best suited for them in that eye first. I like to wait for 2 or 3 weeks before the second surgery.
Initially, I implanted one ReSTOR, and a week later I did the other ReSTOR. Now I wait 2 to 4 weeks, and I let the person see how well they are performing. Then we can make an educated decision on what to do with the second eye.
Dr. Lindstrom: I like that approach. That is what I have done, although I do it with an accommodating crystalens in combination with the ReZoom.
Steve, what will you do for the patient who comes in tomorrow, and why?
Dr. Lane: I am putting a ReSTOR in each eye. You really have to pinpoint what the patient’s goal is in terms of near vision, and whether it really is near or intermediate. After talking to the patient, if I find out that what they want is more of an intermediate range, then I will go to bilateral ReZoom lenses, as opposed to bilateral ReSTOR lenses. If they want good near vision to read I will go with bilateral ReSTOR lenses. We go over that in the office.
Other considerations
Dr. Lehmann: We have not discussed lens design. For myself, I am hooked on the single-piece lens. I have a bit of an aversion using the ReZoom because it is a multipiece lens, although I am pleased to see that it is available in an acrylic material now.
Dr. Milne: It will be easier to explant. I have implanted a lot of wavefront-adjusted IOLs, like the AcrySof IQ lens. I see in some patients a complaint of negative photopsia with those lenses. The patient describes a superotemporal shadowing. It shows up sometimes with the ReSTOR lens also. But I do not know how to solve the problem.
Dr. Lehmann: That is something we need to study further.
Dr. Lindstrom: I would like to thank everyone for their participation.
For Your Information:
- Richard L. Lindstrom, MD, is the Chief Medical Editor of Ocular Surgery News. He is in private practice at Minnesota Eye Consultants, 710 E. 24th St., Suite 106, Minneapolis, MN 55404-3810; 612-813-3600; fax: 612-813-3660; e-mail: rllindstrom@mneye.com. Dr. Lindstrom is a consultant for Advanced Medical Optics, Alcon, Bausch & Lomb and eyeonics.
- Frank A. Bucci Jr., MD, can be reached at Bucci Laser Vision Institute, 158 Wilkes-Barre Township Blvd., Wilkes-Barre, PA 18702; 570-825-5949; fax: 570-825-2645; e-mail: buccivision@aol.com. Ocular Surgery News could not confirm whether Dr. Bucci has a financial interest in any of the products mentioned or if he is a paid consultant for any of the companies mentioned.
- James A. Davison, MD, FACS, can be reached at Wolfe Clinic PC, 309 E. Church Street, Marshalltown, IA 50158; 800-542-7957; fax: 641-753-8717; e-mail: jdavison@wolfeclinic.com. Dr. Davison is a paid consultant for Alcon Surgical.
- Stephen S. Lane, MD, can be reached at 232 North Main St., Stillwater, MN 55082; 651-439-8500; fax: 651-439-5106; e-mail: sslane@associatedeyecare.com. Dr. Lane is a paid consultant and medical monitor for Alcon, and a paid consultant for Visiogen, VisionCare and Bausch & Lomb.
- Robert P. Lehmann, MD, a member of the Cataract Surgery Section of the Ocular Surgery News Editorial Board, can be reached at 5300 North St., Nacogdoches, TX, 75965; 936-569-8278; fax: 936-569-0275; e-mail: Lehmanneyecenter@cox-internet.com. Ocular Surgery News could not confirm whether Dr. Lehmann has a financial interest in the products mentioned in this article or is a paid consultant for any companies mentioned.
- H. L. Rick Milne III, MD, can be reached at The Eye Center, 1655 Bernardin Ave., Suite 100, Columbia, SC 29204; 803-256-0641; e-mail: hmilne@aol.com. Dr. Milne has no direct financial interest in the products mentioned in this article nor is he a paid consultant for any companies mentioned.
- Alcon, maker of the AcrySof ReSTOR IOL, can be reached at 6201 South Freeway, Fort Worth, TX 76134; 817-293-0450; fax: 817- 568-6142; Web site: www.alconlabs.com or www.acrysofrestor.com.
- Advanced Medical Optics, maker of the ReZoom IOL, can be reached at 1700 E. St. Andrew Place, Santa Ana, CA 92705; 714-247-8200; fax: 714-247-8402; Web site: www.amo-inc.com.
- eyeonics inc., maker of the crystalens IOL, can be reached at 6 Journey, Suite 125; Aliso Viejo, CA 92656; 949-916-9352; fax: 949-916-9359; Web site: www.eyeonics.com.