Hi Paolo, can you tell us more about the upcoming lens Artiplus?
Sure! Artiplus is a great new lens design. It’s based on our trusted Artiflex platform, with a different optic. This optic is special because it can correct presbyopia, and also correct aspherical errors, myopia, or light hyperopia.
For which patient groups could Artiplus be a solution?
We aim for a new patient group that normally cannot be helped with surgery. Patients that are either too old for regular refractive surgery or too young for cataract surgery. I would say patients just a little bit older than me, between the ages of 45 and 60. For these patients a clear lens exchange is not a good solution. Why perform surgery on a healthy eye and remove a healthy natural lens? And laser surgery for Presbyopia can only be a partial solution to give some extra reading power. However, these patients are unhappy because they do not want to wear reading glasses. With Artiplus we have a lens that can help this group become spectacle independent.
You already mentioned the optics, what’s so special about it?
For Artiplus we used our innovative CTF technology. We already implemented this technology in our Precizon Presbyopic NVA, our multifocal cataract lens. It’s a multisegmented optic, where the different segments generate multiple elongated focal points allowing a full range of vision. Patients are able to see clearly again at all distances; far, near, and intermediate. I always use the example of our CEO, who has the Precizon Presbyopic NVA lens in his eyes, and I have never see him wearing reading glasses. We did make some changes in the optics, because Artiplus serves a different patient group. For this lens, we developed an aspherical surface, and work aberration free. The eye is an amazing optical system. We do not want to affect it with extra aberrations. We try to correct vision in a healthy eye and preserve the natural vision properties that the eye gives us. The add power of Artiplus is +2,5D. This way, we are able to offer the same reading distance as our Precizon Presbyopic NVA, despite the lens being positioned differently in the eye. If you take a look at classical bi- or trifocal lenses, you will notice they have peaks where they have a good vision, while in-between vision might perform less. EDOF lenses often offer good intermediate vision, but are insufficient for near vision. With Artiplus we offer good vision at all distances.
What are the benefits of using an iris-fixated IOL?
As a surgeon, you can take advantage of all the benefits from our trusted Artiflex platform. Its reversible, it allows you to operate in a safe distance from the natural lens and it offers excellent centration on the pupil. For toric lenses like the Artiflex toric, and soon the Artiplus toric, you can position the lens optimally to correct astigmatism. The lens will not rotate at all. Additionally, this platform offers a one size fits all solution. As long as the patient fits the inclusion criteria, you would not have to worry about the white-towhite diameter (WTW) or IOL sizing. You’re good to go.
How is the set-up of the clinical trial? What stage are you in?
Artiplus is already commercially available in South-Korea and under clinical trial in Europe. We’re currently running a multicenter study in Spain, South-Korea and in the Netherlands. The lead investigator is Prof. Dr. Guëll, former President of the European Society of Cataract and Refractive Surgery (ESCRS). We have a wellbalanced patient population, with approximately 60% Caucasian and 40% Asian individuals. Currently, we have successfully implanted 40 patients binocular, so twice as much eyes. A six-month follow up will be conducted before submitting the data to the notified bodies for the CE mark. We expect to deliver patient data and clinical results in the beginning of 2024.
How are the first study results?
The results are really good. We see the same wow-effect for far vision that we know from our Artiflex lenses, combined with great results for intermediate (80cm) and near vision (40cm). This is off course important, but in our opinion not everything. The feedback we get on our CTF technology is that it provides excellent natural vision. In other words, patients experience smooth transitions between distances and do not suffer from side effects like halos, glares or dysphotopsia. Most patients are extremely happy with the quality of vision. We are particularly proud on the defocus curve. Artiplus performs very well compared to trifocal lenses, which are considered the golden standard, at least for cataract lenses. We have a very flat curve from far to near and we outperform other available products in the market on near sight.
Could this lens also serve as an add-on for cataract patients?
That’s a concept we’re exploring with our Korean colleagues and doctors. Suppose you had cataract surgery, but you still need to wear reading glasses. In this case, Artiplus can be implanted in the eye. You would not have issues with anterior chamber depth (ACD), you have plenty of room, and you can still perfectly irisfixate the lens. Already a few lenses have been implanted as piggy bag solution in South-Korea. If we keep getting promising results, we could decide to register for this purpose in Europe as well.
Which patient’s reaction impressed you most?
I had the pleasure to be in the operating theatre with Dr. Cézon in Seville, during the surgery of the first patient within the study. Dr. Cézon is an experienced user of Artiflex. The patient was a bit tensed, but after surgery he was already making jokes. Although it’s not described in the protocol, the doctor gave him a bottle of hand gel on the first day post-op. The patient could already read the smallest letters on the label, one day post-op! To us, that was an impressive moment. And we continue to get good feedback from other patients. We are absolutely convinced we have something special with Artiplus. What are you personally proud of? Being a technician, I love the fact that we managed to put our CTF technology on a different platform, and tailored it for a different need. We did not create just another multifocal or toric lens. No, we created a lens that covers a whole new patient segment and can really make a difference for doctors and patients.
And our final question; is this our best lens ever?
Oh, that’s a tough question! Our Precizon Presbyopic NVA is also a fantastic lens, our first lens with CTF technology. We have copied and adapted this technology. Therefore, the optics on Artiplus is amazing, it’s a beautiful material, and it’s a beautiful lens. So maybe it is our best product. ”Ogni scarrafone è bello ‘a mamma soja”. Every child is beautiful in the eyes of his mother, or in my case the eyes of the father.