Femtosecond Laser to Revolutionize Cataract Surgery

The Hottest Topic: Femtosecond Laser for Cataract Surgery

Roger F. Steinert, MD: Hello. I am Dr. Roger Steinert, director of the Gavin Herbert Eye Institute and professor and chair of ophthalmology at the University of California, Irvine. I am here today with 2 distinguished panelists and friends, Dr. Ron Krueger is professor of ophthalmology at the Cleveland Clinic Lerner School of Medicine of Case Western Reserve University, and Dr. William "Bud" Culbertson, who is professor at Bascom Palmer Eye Institute of the University of Miami. Thank you for joining us today.

The topic today is the femtosecond laser in the refractive cataract surgery arena -- probably the hottest topic of the moment in ophthalmology and the hottest topic at the Academy of Ophthalmology (AAO) meeting. Before we get into the issues of cost, patient flow, and time impact, which are probably some of the biggest challenges, I would love to hear your thoughts about what this technology is all about. Why are we all so excited about this? Why are so much work and effort and resources being put into this?

Ronald R. Krueger, MD: The technology that allowed refractive surgery to grow and expand and become more precise for better outcomes is now spilling over into other areas. It is spilling over into a market as big as cataract surgery and generating a lot of attention because of the implications about the size and scope of it and what it might potentially deliver in terms of improved outcomes from a refractive perspective. Refractive surgery is moving more into mainstream ophthalmology with this technology.

Dr. Steinert: Bud?

William W. Culbertson, MD: It is taking a procedure -- cataract surgery -- that has for hundreds of years been manually performed and automating a lot of the steps that have been inconsistent, unrepeatable, and indefinable, making them more consistent and definitive, with a more predictable outcome, and potentially, [leading to] a safer procedure.

A Huge Refractive Component

Dr. Steinert: I would agree. I was interested to see this technology, which those of us who were in it from the beginning conceived as a way of softening the nucleus and maybe getting away from ultrasound. Although that is still being pursued, it has almost taken a back seat to some of the other things that have come along, such as incisions and capsulotomy.

We had a town meeting sponsored by the American Society of Cataract and Refractive Surgery/Eye World last night. One of the audience questions was, "What aspect of this procedure is most interesting to you?" The 2 aspects at the top of the list were the incisions and the capsulotomy. People are getting that message loud and clear.

So in just a few words; why is this so important for incisions and capsulotomy?

Dr. Culbertson: Cataract surgery has changed to a very refractively oriented type of procedure, with patients expecting a good outcome with minimal reliance on spectacles and other visual aids. They want to see better -- without glasses -- than they ever have. This gives us a chance, by being able to define these very important parts of the procedure, such as the capsulotomy and the relaxing incisions and even a cataract incision, to make it much more predictable with a potentially better outcome.

Dr. Krueger: Yes. What you say about capsulotomy and incisions, yes, that is a big focus. There is a huge refractive component. With those incisions being very precise, intrastromal, we should hopefully get to where we have no astigmatism left after the procedure. We can achieve a self-sealing wound that will close up and make the whole procedure potentially a little safer but also more precise. The capsulotomy will help us keep good centration of our premium channel intraocular lenses (IOLs).

The interest is also big on nucleus fragmentation because when we are dealing with denser nuclei, we are dealing with potentially higher-risk patients, those who might have pseudoexfoliation or other conditions that make it more challenging to safely do phacoemulsification. Here are some tools that will make it easier, and that is not the refractive side. Ultimately, the refractive side is going to pay for some of this technology. However, just having this available is going to make it better all the way around from a safety perspective.

Dr. Steinert: We are going to come full circle and ultimately this is going to be very powerful in terms of nucleus removal, and perhaps [it will] completely supplant ultrasound. We might just take a little bit of time to get there.

Of course, the United States, unlike the entire rest of the world, has this peculiar situation where by federal law we cannot add a surcharge to the patient for using this technology in a different or better way unless we do very elaborate studies that show a true difference and that it is actually cost-effective, which is going to be a real stretch. What we can do is patient-shared billing for refractive procedures. That is driving some of the interest in the astigmatic incisions and the capsulotomy.

It is a unique characteristic of the femtosecond laser that it can perform capsulotomy in a more precise and repeatable fashion. It can perform not only precise and repeatable incisional astigmatic procedures, like we have always done, but another thing it can do (that a lot of people had not heard of until this meeting) is intrastromal astigmatic keratotomy and get some effect without violating the surface.

Dr. Culbertson: Right. There are a lot of advantages to intrastromal astigmatic keratotomy. Even if the effect of the incision is less than you might get with an incision that breaks out to the surface, the patient doesn't have the discomfort and prolonged irritation that might be associated with a traditional incision that breaks out to the surface. So even though we are able to treat larger degrees of astigmatism with the traditional arcuate keratotomy or limbal relaxing incision that breaks out to the surface, these intrastromal incisions have the potential to enable us to treat small but very important amounts of cylinder that affect our premium IOL patients.

A Sophisticated Piece of Equipment

Dr. Steinert: We are starting to get into the issue that, although we extoll the wonders of this technology and its potential benefits, it is expensive. Is this like computers, and it will plummet in price in a year or two? Why is this all so expensive?

Dr. Krueger: You could look at it like computers. That is, if you sit back and say "I'm going to wait until the best computer comes out and the cost comes down," you are going to be left way behind. There is this idea that you need to make some kind of entry into this at some point in time. You need to do the proper cost analysis.

One question would be, "Why is this so expensive? Why is such a large cost being accrued for this?" A big part of the reason is that it is a very sophisticated piece of equipment. The femtosecond lasers for LASIK surgery were sophisticated and had their own cost issues.

However, now we are not just making a single layer or some ultimate depth in the cornea. We are going into much deeper structures. It takes different optics to get there. Now we have to link imaging to the whole process because if we can't see where we are, we are going to be in unsafe territory. Putting all that together in one box that is reliable and predictable every time takes a bit of money, but it is going to give us a fantastic tool.

A "Disruptive Technology"

Dr. Krueger: It is going to offer us a lot more than cataract surgery. It is going to help us with corneal surgery and with other things. We are scratching the surface of using femtosecond lasers as a new cutting tool in ophthalmology.

Dr. Culbertson: It does open the potential for special types of IOLs that, for instance, integrate with the capsulotomy or are dependent on the capsulotomy. It may give us the option of achieving an accommodative IOL with a design that we have not even anticipated to this day. So, new advances are permissive with this type of technology.

Dr. Krueger: We are scratching the surface of the future, even the concept of saying some day we will make tiny little 1-mm incisions. We will go in and have a less than 1-mm capsulotomy. Everything is going to be prefragmented and easily extractable. Then you are going to inject a new IOL inside a capsular bag to keep things as physiologic as possible. That seems pretty far out -- it's space-age -- but this is the kind of technology that will actually make something like that possible in the future.

Dr. Steinert: Right. This is typical of what they call "disruptive technology." One thing it is going to disrupt is all the other assumptions, just like phacoemulsification led to small incision lenses. We would never be doing small incision lenses if we didn't have phacoemulsification. So I would agree with you completely that this is going to trigger a whole new set of innovations that we can only speculate on and have a very hard time even imagining in the future. That is really exciting.

Practical Realities: Cost and Time

Dr. Steinert: Let's talk about one of the realities, which is cost. Because this is expensive and is not going to be cheap any time in the near future, how are we going to pay for all of this? How do you make this work?

Dr. Krueger: In the United States, we are going to have to face it, like you said, as a refractive procedure. We will need a way to identify the components of the procedure that are not the traditional cataract surgery -- the refractive component -- whether it's astigmatism, which is the main one, or something else that we may be able to identify as a very refractive focus. Then, our patients will have to understand that this is an additional thing that they can pay for to allow their procedure to have more precision, and [to gain] an improved level of visual outcomes.

It will be just like patients pay for LASIK surgery now. They say "I don't want to wear glasses anymore. I want to have this procedure so that I can have this freedom." This is the type of thing that they are going to want to pay for (for cataract surgery) to have that enhanced predictability of outcome. The hope is that we can get the predictability of cataract surgery to be as good as that of LASIK surgery, but it's not there now. This technology will help us get there.

Dr. Culbertson: There are other costs in addition to the instrument itself and the per-procedure fee. There is the extra time that it takes to perform this procedure, perhaps requiring more personnel. It does save you time during the actual cataract surgery, but that is offset by the extra time required for the patient to be positioned under the laser and the physician to come out and do that.

More time is involved, as reported by the people who have the unit in their clinics or in their offices. We are still trying to sort out the best scenario. It certainly will vary from institution to institution and from operating setting to surgery center. There is even the potential for combination instruments that can perform both LASIK and cataract surgery. There are a number of different options, and we are just starting to learn the best patient flow and so forth.

Early Adopters Weigh In

Dr. Steinert: In one of the sessions at the AAO meeting, among people who have started to use this, the uniform consensus was that they did not want this device in the operating room itself because that is the most expensive space. They all envision it being used in a clean but not sterile area adjacent to the operating room.

The refractive center issue comes up too, particularly with respect to the potential for using an IntraLase^® installed base to do incisions and capsulotomy. There is also the issue of transportation -- would you do a patient remotely? Once that capsule is open, the clock is ticking. Anything that disrupted that could cause a problem. So people were not very comfortable with the idea of doing it far off-site.

In a significant number of facilities, refractive surgery is performed right in the same environment as intraocular surgery, so you could have combined units. The optics and numeric aperture and all are real challenges between flap makers and deep-inside-the-eye procedures. That is going to be an interesting technological hurdle as well.

Dr. Culbertson: It looks like there is a time period that is important, in terms of the time interval between performing the laser treatment and then performing the cataract surgery, because it appears that the pupil becomes smaller beginning with the laser treatment. To some extent, this is reversible with intraocular pupil dilating agents at the time of the surgery. However, it appears that you don't want an extended period, such as overnight or many hours between the actual lasing [laser treatment] and the surgery.

No one has yet studied whether there is a significant rise in intraocular pressure during a certain period of time after the treatment. It appears that time is of the essence after the laser treatment and before the surgery.

Dr. Krueger: One of the investigators said that if you wait too long, there would be some leakage of proteins that might increase the intraocular pressure. You have to look at this as a procedure that is going to be along the same time period as the actual surgery. When you think about it, however, it is 2 separate procedures, in a sense. It is pretreatment with the femtosecond laser and then the cataract surgery.

The extra time that is involved in doing this pretreatment should be looked at as another procedure. If there is another billable of refractive component, think of it as another procedure. In that sense you are saving time because you are doing 2 separate things, the refractive component and then the actual extraction and implantation. Even though the whole thing will take a little longer, separately and for what you are billing for, it should be less time.

Dr. Steinert: I would like to thank Dr. Krueger and Dr. Culbertson for sharing their thoughts. It has been a very thought-provoking discussion, and you raised a lot of the issues that have all of us so captivated with this technology. Thank you all very much for joining us. I am Roger Steinert for Medscape Ophthalmology Insights.