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OSN round table: Presbyopia becoming a subspecialty of ophthalmology

Issue: April 25, 2017

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At the European Society of Cataract and Refractive Surgeons meeting in Copenhagen, Denmark, Ocular Surgery News gathered a panel of international experts to discuss the current state of presbyopia correction.

George O. Waring IV, MD: I will start with some demographics. In 2020, there will be more than 2 billion presbyopes worldwide, so that is 4 billion presbyopic eyes. What is your perspective on these demographics?

Aylin Kiliç, MD: In the past we were doing more LASIK, but LASIK has been going down in popularity. With technological advances, we in presbyopia are making advances in multifocal treatments, so while LASIK is declining, we are seeing many more lens-based solutions for presbyopia developing.

Image: Waring GO

Sheri Rowen, MD, FACS: As soon as somebody starts losing their near vision, that is the beginning of what we call the dysfunctional lens. The lens is not accommodating properly anymore. Those of us who are involved in this space are starting to understand how to restore that function in some way. We have seen it as correcting vision up until now, but I think the paradigm is starting to change where we are thinking about restoring natural accommodation and restoring lens function and utilizing a “staging” system to determine which procedure is best for our patients based on their clinical manifestation of presbyopic dysfunction. Perhaps this method will allow us to treat the vision loss early on so that we do not have to go to the point where that is lost and then we have to do vision correction. If we can start shifting the paradigm to that younger age group, I think we will achieve the goals we are looking for.

Elizabeth Yeu, MD: From the perspective of refractive surgery in general, so much has changed. Yes, there is corneal refractive surgery, but the options have always been limited when it came to presbyopia correction. Those patients who are moderate or mild myopes, who are aged 40 and up who are seeking both distance and uncorrected near visual acuity in whom we do not want to seek that IOL option, now have the expanding base of corneal as well as scleral and pharmacologic methods. I think it is going to increase our armamentarium. We are finally coming to a point that presbyopia correction is going to boom the way some other fields in the anterior segment space have.

Karl G. Stonecipher, MD: In the “old days,” 5, 6, 7 years ago, you spent so much time explaining the side effects or the downsides to the lens. As our technology has gotten better, we are now spending less chair time on the limitations of this technology and what we are going to do for solutions.

Jorge L. Alió, MD, PhD: In my practice, we have two main groups. One is the patients coming for cataract surgery, and in my hands these patients are implanted with a multifocal lens 60% of the time. The second group is those who are coming for refractive purposes and probably because of natural evolution of the market; about 55% to 60% of the patients are in their 30s, early 40s or middle 40s. These patients come because they have glasses not only for far, but for near as well. Some of them are myopes, some of them are hyperopes, and some of them are emmetropes. There is no one solution for every patient. These patients are hypersensitive to problems, refractive surprises and unusual complications. This is a hypercritical group, but they are willing to pay to get the results they expect.

Waring: In our practice, patients come in and we profile them based on age and why they have come to our practice. We have a corneal refractive track, we have a lens refractive track and then a cataract track. When you look at all the options available today, I like to use the analogy of non-MIGS glaucoma surgery, which historically requires fellowship training for the many options for the surgical management of glaucoma. We now have so many options for the surgical management of presbyopia, I predict we are going to see a spawning of fellowship training in presbyopia surgery, as an emerging sub-subspecialty.

We educate our patients on dysfunctional lens syndrome (DLS) and reassure them that this is OK and natural. The characterization of DLS is an attempt to characterize the aging changes of the human crystalline lens, and it helps in our decision making whether it is going to be a corneal-based procedure, a scleral-based procedure or a pharmacologic-based procedure in stage 1 because you still have relative clarity, or perhaps a lens-based solution for stages 2 and 3.

Let’s define dysfunctional lens syndrome. It is basically the onset of presbyopia, which is really stage 1. Stage 2 is increasing higher-order aberrations and loss of clarity or some early opacity that is not keeping patients from performing their daily activities, and these are both in the U.S. still self-pay-based procedures. Stage 3 is where their daily activities are now hindered, and therefore, they qualify for an insurance-based procedure. We take them on a tour of their own eye with a digital lens-based exam, and we show them we have lasers not only for cornea-based procedures but lasers for lens-based procedures also because they are originally coming in for laser surgery.

Stonecipher: In our practice, just to take it one step further, we are always talking about what the patient does. I take that to, “What are your daily habits, what is your job and what are your daily hobbies.” So if you have somebody who is an airline pilot but they also sew, or if they are a target shooter and they are an accountant, maybe you have to look into mix and match. We bring in the concept of enhancement before we even start.

Rowen: In our practice, we have a high percentage of post-refractive patients, and I think we are all going to see these in much greater numbers. These patients are demanding. They have had good vision. They had excimer laser years ago, and they achieved the perfect result, and they think they are going to get this again with the new technologies that we are doing. Now we need to customize. Each person may have so many needs, and most of them say, “Well, I want to see here up close. I want to see at my computer. I want to see far away. I want it all.” That is what we are dealing with today: “I want it all.”

Alió: We are no longer in the era of the LASIK surgeon, so no longer are you a cornea surgeon or a cataract surgeon. You need to master all these techniques in the benefit of the patient. You cannot accomplish this with the old-fashioned idea of being a LASIK surgeon.

Stonecipher: You are a refractive surgeon.

Waring: How many people feel that eye dominance is important in your practice?

Stonecipher: Alan Faulkner and I did a series we presented at Hawaiian Eye 2016. Everybody thinks eye dominance is so easy to determine. People can be ambidextrous with their eyes, and we found that it was about 25% to 75%. So, 75% preferred their dominant eye, say, for distance and 25% preferred their non-dominant eye for distance. I think you just have to see what the patient needs; you have to find out that individual patient’s needs.

Waring: This is a really interesting point that is not well understood, and it is the concept that Dr. Stonecipher just introduced of near dominance. We, to the best of my knowledge, do not have a way to actually test for near dominance.

Lucio Buratto, MD: Many patients do not have a dominant eye. When we decide what to do for which eye to use for near depends on the needs of the patient. If they are drivers, we have to give the dominant eye for far. If they are dentists, they use their dominant eye for near, so I think every patient is different, especially in presbyopia.

John Chang, MD: We have not really been testing the near dominance. It is quite important because sometimes even when I put in a strong add in the non-dominant eye, the dominant eye is so dominant that they cannot read. So, the near dominance is important. Also, I find that even for far dominance, the non-dominant eye is more tolerant to dysphotopsia and residual refractive error than the dominant eye. So actually, distance dominance is important and near dominance is also quite important.

Yeu: That is the key, the distance dominance, and for that eye, you have to nail the distance. You cannot compromise the quality of their distance vision to gain near. You will rarely have someone who is satisfied if that distance vision is off-target, but with the near vision, you have more room to play with. We need to recognize that with all these different technologies, we have to nail the distance.

Waring: Another way that we think about this is optical vs. motor dominance. We have found optical method to be a more sensitive indicator of dominance. The way we determine this is that we blur their best corrected distance vision and whichever eye is more tolerant to blur, often with a +1.50 D lens over the best corrected distance visual acuity, will be the non-dominant eye.

But that does not answer the question of near dominance, and I think Dr. Buratto’s point is excellent. It is just listening to the patient and profiling your patient. Those are the patients we have also found to be near dominant, and we have had success in the past with actually changing their refractive circumstance to provide a near solution in their dominant eye in architects, patients with high near add requirements, and they actually do much better when you swap them.

Blended vision

Waring: How many of us are still using a blended vision approach with LASIK?

Stonecipher: Again in the study that I talked about, somewhere between 1.25 and 1.75 is pretty well tolerated. Depending again on what that specific patient’s needs are, our sweet spot is probably somewhere between –1.25 and –1.50 that is tolerated. And if it is not, you always tell them beforehand: If you are not where you want to be, we can always come back and touch it up.

Yeu: I think this is where inlays are going to have some huge strengths because now in my 40- to 45-year-old groups, some of them are saying no, just make me distance, and we do not have to have that extensive conversation because I also tell them there is another technology now that is going to help them when they need it. But even when I am doing my blended vision, I do not mind if it is a 48-year-old that I am leaving –1.00 to –1.25 because that is all they need. By the time they are ready for more, I will have a better option for them, whether it is going to be pharmacologic or surgical, but I do not feel that I have to give them that imbalance of greater refractive disparity between the two eyes and I do not have to set the monovision to the point of creating stereopsis issues. I think that we do have greater creativity and customization that is allowed.

Waring: An important theme that seems to be arising with different technologies is adding a small amount of defocus to asphericity. It seems that it is not enough just to do a Q value adjustment, but to add defocus as well. Because of the increased depth of focus, however you do it, it is more forgiving with the defocus as well.

Stonecipher: One of the things I say to the patient is, “Look, we’re operating on you as a static individual at this point, but we’re also thinking of you 10, 20 years down the road and we want to preserve what we can because technology is going to change and we want to be able to have that as well.”

Waring: That is right. It is a “vision for a lifetime” paradigm.

Rowen: Which is why I get back to the original concept that as we are approaching these patients and we are starting to look at new modalities, being able to preserve natural accommodation or being able to preserve their natural depth of focus will be much better for the future because we will be able to incorporate any of our lens technologies in it later.

Scleral-based procedures

Waring: Let’s discuss scleral-based procedures. Right now there are laser-based procedures and there are implants, and our group is experienced with both.

Stonecipher: We started the clinical trials ourselves probably 5 or 6 years ago. I have some patients implanted 3 and 4 years out now, and they are happy.

The nice thing about having a scleral-based approach is you are leaving the cornea alone. They have bilateral binocular vision so they are able to see. Their depth of field, depth of focus, is preserved. The one issue is the patient has to be participatory, so they actually have to realize we are giving them the gym back and they have to use their muscles. We have found many patients who say, “Well, I’m just going to put my glasses on again because I’m not going to do that.” If they will do a near vision task, they preserve it and we have not had a loss. It is almost like immediately after we operate on them, a lot of them get that kind of mindset of, “I went to the gym and I worked out and I’m sore,” so they have started using their muscles again and they complain.

Waring: The other neat thing about the scleral space, and the part of this that has always intrigued me, is that we are learning so much about the mechanisms of accommodation, and it is really challenging the historic paradigms on the physiology behind accommodation.

Dr. Hipsley, you have done a large amount of work and some fabulous research in this area for years. What are your thoughts on how we should be thinking about accommodation and what have we learned from looking at the scleral space?

AnnMarie Hipsley, PhD: We have to think comprehensively about presbyopia as an age-related biomechanical dysfunction. We cannot just be cataract surgeons or just be refractive surgeons. Even glaucoma is now in the “cataract and refractive” space. Therefore, it is time to consider the whole eye dynamics that occur with age and the interrelationships that affect the eye when the accommodation function begins to decline with age. If you think about the physiology of accommodation, we cannot ignore the elephant in the room anymore that accommodation is the only dynamic function in the eye. This function stops working properly when the muscles are unable to move the lens anymore due to age-related changes of the eye organ.

We have this accommodation mechanism that basically participates in all of the functions of the eye, including biotransport of all of the nutrients that flow through the eye organ, the eye drops that we are putting in the eye and circulation of all the antioxidants out of the eye. All of these free radicals that are sitting everywhere in the eye are being regulated by this accommodative pump. In addition, the hydrodynamics of aqueous fluid is also regulated by the accommodation mechanism. Therefore, it is not just the loss of the zooming function of the crystalline lens for visual function that is lost that the dysfunction of accommodation affects, but the entire physiological functions of the eye. Loss of near and intermediate vision is only one symptom of this age-related sort of cascade that is happening in your eye.

I think that we are becoming more conscious about the comprehensive impact that the loss of accommodation has on the entire eye system with the recent identification of accommodative structure and function recently being published. Moreover, scleral procedures and pharmaceutical therapies are finally becoming a viable new space in presbyopia treatment along with the existing presbyopia-correction procedures. I really think that we are embarking on the advent of therapeutic technologies that can finally address the real problem of the loss of physiological accommodation. We have had a plethora of vision correction techniques and technologies available and we still have those tools in our toolbox, but now we have these new therapies, which can be a first strike at restoring function. Perhaps we can keep the eye moving longer by restoring dynamic accommodation and potentially delaying some of the other things that go wrong as we age that require us to remove anatomy or replace anatomy. This is an exciting possibility.

Waring: Let me ask Dr. Rowen. You have been involved with laser application to the sclera for restoration of accommodation. Tell us a little bit about LaserACE technology (Ace Vision Group) and what your experience has been.

Rowen: LaserACE technology has been used to basically remodel the sclera because when you think about the aging eye, the sclera becomes increasingly rigid with age. Therefore, understanding the internal workings of the eye, which we are finally seeing with modern biometry imaging, you can now see how the entire internal eye moves forward all the way back from the optic nerve toward the scleral spur during accommodation. This anterior movement of the choroid facilitates the ciliary body to move the lens zonule complex upward and inward on the lens every single time it accommodates. We are trying to accommodate, and this is what Dr. Hipsley was talking about, this pumping mechanism inside the eye.

The scleral technologies that we are discussing, which create more compliance in the sclera over these critical zones of anatomical importance, which Dr. Hipsley defined in her published manuscript, basically allow more pliability to the sclera so that there are more efficient force translation from the extralenticular anatomy toward the lens. For example, it would be like if you were trying to move a muscle against a brick wall vs. a rubber band. In essence, improving the pliability of the sclera allows it to flex with the internal musculature as it did in a youthful eye allowing that upward and inward movement of the anatomy, thereby restoring more normal accommodative biomechanics. The treatment with LaserACE is performed in four quadrants over these three critical zones that allow the ciliary muscle to work again as it did when you were young.

Waring: Dr. Rocha, I know you also have been involved in clinical trials looking at the optics and performance of this. What has been your experience?

Karolinne Maia Rocha, MD, PhD: We presented at the European Society of Cataract and Refractive Surgeons meeting the long-term outcomes of patients who had LaserACE procedures 10 years ago. Our case series included six eyes, and the average age was 59 years old. All patients had a history of laser vision correction prior to the LaserACE procedure. I had the opportunity to see those patients in clinic now 10 years after the LaserACE procedure, and they had a fantastic range of focus. They were, despite the hyperopic regression, still J1 in both eyes.

I think it is always important to combine subjective and objective measurements of the depth of focus. In our studies, we used ray tracing aberrometry to evaluate true accommodation vs. pseudoaccommodation. Ten years after LaserACE, depth of focus increased from 0.65 D to 1.49 D. Effective range of focus averaged 1.56 ± 0.36 D for all eyes. Changes in spherical aberration, coma, trefoil, defocus and accommodation were noted. VSOTF averaged 0.48 ± 0.13, while the average difference in higher-order aberrations was 0.6 µm. These patients were able to go up to 2.5 D of combined true accommodation and pseudoaccommodation.

Waring: It is really challenging the mechanistic paradigm of accommodation and the role of pseudoaccommodation, and better understanding how we can tap in to both aspects of restoring near vision.

Rocha: Pseudoaccommodation is basically the combination of higher-order aberrations plus dynamic changes of the pupil size (the pinhole effect). The combination of residual true accommodation and pseudoaccommodation provided an enhanced depth of focus in these patients.

Pharmacologic agents

Waring: Let’s discuss pharmacologic agents.

Rowen: I wanted to talk about a very exciting new pharmacological agent from Encore Vision called EV06. It is choline and lipoid acid, and it is actually changing the lens function by restoring microfluidics within the lens. We have not really discussed what happens within the lens in this space. By displacing about 1.25 µL of cytosol to the center of the lens and changing the lens horizontal diameter about 17 µm, you can get 1 D of accommodation with this drop. The initial studies have shown that with 3 months of use twice a day, 82% of patients actually were 20/40 or better vs. 44% of controls. This is something very new and very exciting.

Stonecipher: You have four drops in this space. One is a lens-softening drop, a chemical reaction, that is actually changing the lens. The other three are miosis without accommodation. You have PRX-100 (Presbyopia Therapies), which is Liquid Vision. You have PresbV, which is a PresbV Plus, and then Presby Tears. Liquid Vision, PresbV and PresbV Plus are all miotics without accommodation. EV06 is actually changing the composition.

Rowen: They say now it is not even as much lens softening as restoring the microfluidics within the lens. It is actually movement of cytosol to the center. You are inducing a 17-µm lens shape change.

Rocha: The beauty is you should be able to combine procedures in the future — combine scleral procedures with drops or even just a miotic drop in the patient who is pseudophakic in whom you want just a little extra.

Waring: We are all obviously passionate about the opportunity to help our patients with lens dysfunction. I would like to thank you for this top-level discussion.

• For more information:
• Jorge L. Alió, MD, PhD, can be reached at Vissum Corporation, Avenida de Denia, s/n, 03016 Alicante, Spain; email: jlalio@vissum.com.
• Lucio Buratto, MD, can be reached at Centro Ambrosiano Oftalmico, Piazza Repubblica, 21 - 20124 Milano, Italy; email: iol.lasik@buratto.com.
• John Chang, MD, can be reached at Hong Kong Sanatorium and Hospital, Hong Kong; email: johnchang@hksh.com.
• AnnMarie Hipsley, PhD, can be reached at Ace Vision Group, 39655 Eureka Drive, Newark, CA 94560; email: ahipsley@acevisiongroup.com.
• Aylin Kiliç, MD, can be reached at Dunyagoz Eye Hospital, Istanbul, Turkey; email: aylinkilicdr@gmail.com.
• Karolinne Maia Rocha, MD, PhD, can be reached at Storm Eye Institute, Medical University of South Carolina, 167 Ashley Ave., Charleston, SC 29425; email: karolinnemaia@gmail.com.
• Sheri Rowen, MD, FACS, can be reached at NVISION Eye Centers, 4220 Von Karman , #100, Newport Beach, CA 92660; email: srowen10@gmail.com.
• Karl G. Stonecipher, MD, can be reached at Laser Defined Vision, 1002 N. Church St., Greensboro, NC 27401; email: stonenc@aol.com.
• George O. Waring IV, MD, can be reached at Waring Vision Institute, 735 Johnnie Dodds Blvd., Suite 101, Mt. Pleasant, SC 29464; email: gwaring@waringvision.com.
• Elizabeth Yeu, MD, can be reached at Virginia Eye Consultants, Norfolk Office, Office & Surgery Center, 241 Corporate Blvd., Norfolk, VA 23502; email: eyeulin@gmail.com.

Disclosures: Alió, Buratto, Chang, Kiliç, Rocha and Yeu report no relevant financial disclosures. Hipsley reports she is the founder and CEO of Ace Vision Group. Rowen reports she has financial disclosures with Ace Vision Group and Encore Vision. Stonecipher reports he is a consultant to and does research for Alcon, Presbia and Refocus. Waring reports he has financial disclosures with AMO, AcuFocus and Visiometrics.