Professor Gerd Auffarth shares patients’ and colleagues’ responses to a new IOL with a monofocal-like dysphotopsia profile
IOLs are a major topic of conversation at this year’s European Society of Cataract and Refractive Surgeons (ESCRS) Congress. Over the last several weeks, companies have teased product launches and new clinical findings to be revealed at the meeting.
To learn more, we spoke with Gerd Auffarth, MD, FEBO, who is chairman of the Heidelberg University Eye Clinic and the director of the David J. Apple Laboratory and Center for Vision Research, both in Heidelberg, Germany. He shared findings from the poster he is bringing to Barcelona, "Functional Outcomes After Implantation Of A New EDOF Iol With A Refractive Technology And Monofocal-Like Dysphotopsia Profile.” Along with highlights from those data, he also spoke about what he’s most looking forward to at the conference, provided pearls for patient counselling and explained why keratoconus therapies may be the next big thing in eyecare.
Editor’s note: This transcript has been lightly edited for clarity.
Hattie Hayes: Thank you so much for joining me. I'm excited to talk about your poster, "Functional outcomes after implantation of a new EDOF IOL with refractive technology and monofocal-like dysphotopsia profile."
Gerd Auffarth: In this poster, we looked at a new EDOF lens, which is a non-diffractive technology; it's a refractive technology. And the idea of this lens was actually to get very competitive with one of the first EDOF lenses on the market, which was the TECNIS Symfony. However, this was a diffractive lens, and we all know that, even though it performed quite well, it has kind of a dysphotopsia profile, which was still significant. So the idea of this lens was to develop a non-diffractive technology that gets at least the same outcome.
The lens is called PureSee, from J&J Vision, and I've implanted now quite a bit of those. On the poster, I presented those that we have included in an ongoing study. So, the first 10 patients, we have in this study, and we have full data for 3 months. However, we have used the lens in many more patients, as well. This study is designed to have a follow-up period to 6 months, so it's interim data. Patients are 71-years-old, ±9 years, and the main power of IOL was 22 dioptres, out of 18/20 lenses we've implanted. We only had patients with cataract; there was no toric version available. It's sometimes difficult to select those patients for studies, because the astigmatism must be below half a dioptre.
We had excellent outcomes in terms of hitting the target and getting a good uncorrected distance acuity. We did not have, really, finalised a constant when we started with the study; most people who start now have the privilege of benefiting from all the previous studies.
But we ended up -0.03 logMAR, so it's 1.0 or 20/20, plus, so to say, uncorrected for distance. And corrected distance visual acuity was -0.1 logMAR, so better than that. Intermediate vision, at 80 centimetres, was 0.0 logMAR, so, under 20/20, very good. Uncorrected, at 40 centimetres was 0.3 logMAR, which is like 20/40, or 0.5 on the decimal scale.
Interestingly, from the first month to third month, near acuity improved to 0.2 logMAR. So this is 0.63, or 20/30, which is a significant improvement, which is quite good. And of course, the other values stayed the same.
Let's put it this way: I hope that this lens will end up with an uncorrected binocular near acuity somewhere around 0.2 logMAR, which is actually even more than we expected. But we knew that we will get a very nice lens for distance intermediate and I would say functional near acuity. If we have a hyperopic population, they will benefit very much from it. They can read very nicely. If they are highly myopic, you should actually address more monovision strategies. But the good thing is, we looked at the dysphotopsia, and we knew from optical benchmarks and some simulation of the PureSee that there is, essentially, the same side effect that you have with a normal monofocal lens.
We have a software called a halo glare simulator, where you get actual numbers. A patient has to look at a night driving scene, and you can manipulate size, intensity, form and shape of halos and glare. And on a scale from zero to 100, which is the worst case scenario, the mean halo size was six. So. So essentially nothing. And the intensity was seven, which is also almost nothing, yeah? So we really can say that the patient has absolutely no relevant dysphotopsia, every monofocal has this kind of halo and size and intensity. So this was quite, quite interesting, and we are showing that on the poster.
We also asked the patients some questionnaires [about] what they can do without using glasses. Most of the time, reading a book was, for some people, not 100% but all other tasks were more or less “yes” or “partly possible.” Especially, of course, anything that has to do with intermediate activities, driving, tasks like this. For a new concept lens, and for the very first patients, and even taking into account that we were still at the forefront of IOL calculation, I think the outcomes are excellent. I think if we have the toric version, which we have already handled quite a bit of those though not in this study, then we can find more data and get to a very nice outcome.
HH: For patients, [dysphotopsia is] certainly something that I think brings a lot of patients concern or worry before they explore IOLs. Do you consider that dysphotopsia to be one of the biggest challenges that they face with IOL implantation? What's that patient response been like?
GA: Well, the thing is, our patients are much more informed than they used to be. Very rarely does the patient come and say, “Doctor, you decide, and whatever you say is right.” That’s especially true if we look in this premium lens group, or if you look in the presbyopia correcting type of surgery, and not in the 90-year-old grandma with a cataract. So, here, we're talking about active patients who come to you, and may pay out of pocket, and are much better informed. They already tell you, I don't want anything with rings or haloes. They have some ideas, and sometimes we have to actually talk them out of the ideas. But in general, it's very comfortable for me as a doctor, to say, “Okay, we have an alternative. We have a non-diffractive lens, no dysphotopsia. You may have some issues if you want to see very small print. You have to live with that, or you have to take some spectacles for the near vision from time to time.”
Often, if you talk to the patient, you see how they behave, what kind of personality they have, you get an idea that they might be a little bit annoyed with haloes and stuff. If they already agree, then they are relaxed, and they…would be actually even suitable for diffractive lenses. More and more, you automatically [know when to] recommend that.
HH: That's wonderful, and I can only imagine how excited patients are to know that this is available to them now. What has the response from your colleagues been like, when they see these data, and learn more about the functional outcomes of this lens?
GA: At meetings, when I give a lecture about this kind of technology, I actually usually star by discussing the first lenses that we had, the bifocals, and talk about the different types of diffractive technology. It’s quite interesting. We got excited at the beginning, that we had that [technology], and kind of lived with the problem of dysphotopsia, and now I'm very happy that there's a solution for it. And for my colleagues who are a little bit older, and went through all these evolutions, they are like, “Oh, we have waited for it. We have waited for this kind of technology. Finally we can offer the patient this kind of stuff.”
Of course, nobody likes to have long chair times with patients who complain, or unhappy patients sitting in the waiting room. And that’s what I get back, as a response from colleagues: With this kind of technology, you don't really have these problems. People are pretty confident to use it, and it is well-accepted.
HH: Speaking more broadly about the ESCRS, you know, it's a meeting that gets bigger every year. What are you most excited to talk about in the refractive space with your colleagues–whether it's something that you're presenting on, presentations you're excited to watch, or just something you're excited to discuss in between sessions on the show floor. What are you most excited to dig into?
GA: As you said, it's a huge congress, and a lot of people save their good stuff for the meeting here. And a lot of companies use the ESCRS to launch a new product. Just a minute [before this interview], we shared some news on the lenses from Rayner, the Galaxy lens, which is quite exciting. It's a refractive technology with a spiral IOL, also with a very low dysphotopsia profile. I think, in general, lowering the dysphotopsia, with any kind of technology, will be one of the important issues for presbyopia-correcting IOLs. J&J has the PureSee, Alcon offers the Vivity, Rayner has the RayOne Galaxy and EMV. Other companies are coming with new lenses, too, like trifocals that use, more or less, 95% of light, thus reducing side effects. So there are a lot of new technologies aiming at the same spot, fulfilling a kind of spectacle independence for patients.
Now we, ourselves, from University Eye Clinic Heidelberg, also have a course on avoiding dysphotopsia with modern presbyopia-correcting IOL technology. We have a lot of lectures covering IOL technology, but also in the space of keratoconus diagnostics looking at machinery like the Pentacam AXL Wave (OCULUS), the anterior machine. There are more and more features in these machines, so you can pre screen patients who have subclinical pathology, and very early, can detect them and guide them.
And in terms of corneal surgery, we are seeing new keratoconus treatments, like CAIRS [corneal allogeneic intrastromal ring segments], using an excimer laser to make a pocket and then put in some allogeneic corneal material. We have started that also here, with very good outcomes. The cornea becomes a very exciting area, similar to the developments we had 10 years ago, with all these IOL types, cornea is now a big thing.
A lot of these things have been done already, but not in this quality, and with this ease thanks to new technology. Diagnostics and technology and treatment methodologies come together now, and I think this will be quite interesting,
HH: Wonderful. Well, I believe you have answered all my questions—thank you so much!
GA: I think we covered quite a bit! That's great.