US surgeons benefit from early adoption of premium IOLs by European colleagues
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In the United States, the pool of presbyopia-correcting IOLs has expanded significantly in recent years.
Between 2019 and 2021, the FDA granted approval to the diffractive trifocal AcrySof IQ Panptix (Alcon) and Tecnis Synergy (Johnson & Johnson Vision), the extended depth of focus (EDOF) Vivity (Alcon) and the Eyhance monofocal “plus” (Johnson & Johnson Vision), with all four also available in a toric version. In addition, in 2019, the Light Adjustable Lens (RxSight) was launched, while the IC-8 small-aperture IOL (AcuFocus) is currently undergoing the premarket approval process.
Source: Gerd Auffarth, MD, PhD
However, the number of options available is far from approaching the variety of IOL models currently used in Europe, where a less onerous regulatory approval process — CE marking — grants easier and faster access to new medical technologies.
“In Europe, we have access to new technologies at least 3 to 5 years earlier,” Gerd Auffarth, MD, PhD, said. “A wider variety of options is an advantage because we can tailor our choices to individual patients, including the difficult cases.”
“It makes our job easier,” Filomena Ribeiro, MD, PhD, said. “We have now a full array of presbyopia-correcting IOLs to cover the range of vision that satisfies the needs of each patient individually in relation to their lifestyle and ability to perform activities of daily living.”
On the other hand, the rigorous approval process of the FDA gives U.S. ophthalmologists full confidence in whatever product they use.
“We have set the bar so high with many of our technologies that definitely there is a level of comfort that I do feel with our FDA process,” OSN Technology Board Member Kathryn M. Hatch, MD, said. “When I incorporate a lens into my practice, I usually tell patients the implant has been around for a period of time, typically in other parts of the world, and it has gone through rigorous FDA trials.”
“The more tools we have, the better, because our oath is to try and deliver on the trust the patients put on us. But I also trust the FDA process, as it ensures high safety standards and clear guidance to manufacturers on what needs to be achieved,” OSN Refractive Surgery Section Editor John P. Berdahl, MD, said.
In his view, the less stringent rules of CE marking are a double-edged sword.
“The advantage is that you get access to technologies more quickly, but it is also possible that you may miss a safety signal in that approach,” he said.
Profound impact on medical practice
The slower entry of emerging technologies in the U.S. has created profound differences in medical practice.
“The way our American colleagues use the available products can be quite different from what we are doing,” Auffarth said. “For instance, before trifocal lenses became available, they used bifocal diffractive technology and combined it in a mix-and-match approach with the EDOF lens, creating their own trifocals, so to say. They had good results but had to improvise a little more.”
Another example is Crystalens (Bausch + Lomb), which has been popular in the U.S. while it never took off in Europe.
“It was scientifically proven that the small degree of depth of focus the lens achieved was due to pseudoaccommodation rather than true accommodation. Had it come out now, we would say it is a new type of EDOF, a term that did not exist at the time. In Europe, we never liked the design of the Crystalens, with a very small optic and haptics that were different from what we were used to. The biggest advantage in the U.S. was that it became reimbursable for patients on Medicare,” Auffarth said.
Patient expectations may also be different in Europe and the U.S., and this significantly affects the attitudes and viewpoints of physicians, according to Auffarth.
“My impression is that European patients expect more. Since Europe made advanced-technology IOLs available earlier and in a wider variety of options, they have become more demanding,” he said.
Variety of designs, materials, delivery systems
Trifocal options that are available in Europe and not in the U.S. include the Zeiss At Lisa tri family, the VSY Acriva Trinova and the PhysIOL/BVI FineVision family. The latter also includes Triumf, a hybrid trifocal model that combines features of bifocal and EDOF technology, similar to the Symfony IOL.
“Among enhanced monofocal IOLs, in addition to the Eyhance, we have the PhysIOL/BVI IsoPure and the Rayner RayOne EMV, which extend depth of field by increasing negative and positive spherical aberration, respectively,” Ribeiro said.
Several lenses are a transition between monofocal plus and EDOF, such as the Xact Mono-EDOF (Santen) and the LuxSmart EDOF (Bausch + Lomb).
“The trend in Europe is to define IOLs by the range of vision they can provide, from full range to prevalently far or far and intermediate,” Ribeiro said.
The interest in intermediate vision has grown significantly in recent years because of the widespread use of screens. Trifocal lenses may be suitable only for perfect eyes, but other patients can achieve good intermediate as well as far vision with one of the other many options, she said.
Within the same category of lenses, or even within the same family, there is also variety in terms of material, haptic design and delivery systems, Auffarth said.
“Among trifocal lenses, for instance, we have hydrophobic acrylic as well as hydrophilic acrylic. We have plate haptics and C-loop haptics. We have preloaded IOLs or IOLs that we have to load ourselves,” he said.
Hydrophilic lenses have been used in the U.S. in the past but are no longer the standard, which would probably limit the acceptance of some IOLs, such as the At Lisa.
“Here, many of us still like hydrophilic lenses. They have some advantages in terms of injectability and size of incision, and they are much more forgiving when they glide into the eyes, so they are overall easier to implant,” he said.
Another trend that is characteristic of Europe is the presence of four-point fixation lenses, such as the PhysIOL/BVI IOLs, the VSY lenses and the Teleon lenses. Four-point fixation helps optimize stability and centration in the capsular bag, Auffarth said.
Diverse technologies
Teleon, previously Oculentis, has a wide variety of options for presbyopia, from multifocal to EDOF to enhanced monofocal, as well as a unique segmented optics technology.
“The Comfort IOL has a very specific bisegmented design. It is a low-add refractive EDOF with a 1.5 D near addition. It provides outcomes similar to those of a diffractive EDOF but with better contrast and much fewer side effects. It is an interesting concept, and it is now available in a hydrophobic lens material that has overcome the calcification issues with previous hydrophilic IOLs,” Auffarth said.
His most recent interest is binocular complementary technology, such as the Artis Symbiose (Cristalens). Two similar lenses with complementary profiles, one optimized for near vision and the other for intermediate vision, are implanted in the nondominant and dominant eye, respectively, to provide full-focus vision from 40 cm to 90 cm without compromising distance vision.
These paired lenses are an evolution of the mix-and-match concept and overcome the downsides of implanting two IOLs with different platforms.
“Lenses with the same design should, at least theoretically, lead to better binocular summation,” Ribeiro said. “A further evolution in this direction is the Synergy lens, which combines two technologies to deliver ‘in the zone’ continuous vision.”
Pinhole optics IOLs are available as a primary implant, the IC-8, and as an add-on implant, the Morcher XtraFocus.
“Add-on IOLs provide a good solution for pseudophakic patients previously implanted with a monofocal who want to become spectacle independent. I also use them in cases where I have doubts about biometric accuracy or potential pathological developments in the future. The pinhole add-on IOL is a very good solution in very irregular corneas. It provides good vision and extended depth of focus. It is the true EDOF concept,” Ribeiro said.
More options without lowering standards
Hatch is looking forward to incorporating the IC-8 into her practice.
“I am definitely excited about having that implant available, hopefully in the coming year. There are trials going on with other types of multifocal lenses in the U.S., and I am waiting to hear more about these other technologies, but the IC-8 lens, along with providing increased range of vision, may play a key role in patients with irregular corneas who are not great candidates for multifocal lenses. If they are looking for some extended depth of field, the IC-8 may be the best solution for its ability to reduce higher-order aberrations,” she said.
As a surgeon involved in FDA clinical trials, Berdahl has had the chance to gain experience with some of the technologies not yet available in the U.S. He said that, eventually, he wants them all because the more tools he has in his tool kit, the better he will be able to satisfy his patients.
“I believe in the process, meaning we do the science, we do the work, we get the data, and then we get the experience,” he said.
FDA approval indicates that strict criteria and high standards have been met and that clinical application of a device will be safe and effective.
“The FDA has done a good job of keeping unsafe products off the market. High standards for safety, efficacy and quality have to be met, and every claim must be supported by the data generated in studies,” Berdahl said. “For IOLs, there are standards that the FDA uses to determine extended depth of focus, and there are standards to determine multifocality, and those standards need to be met in high-quality controlled randomized clinical trials. The FDA provides clear guidance on what needs to be achieved, and this helps the manufacturers to decide: Can we achieve this or not? Can we support our claims with the data that we’re going to generate? I believe that the FDA approval process works pretty well for presbyopic IOLs,” he said.
Berdahl sees the upside and downside of CE marking: on one side, the benefits of quicker access to technology, and on the other side, the risk of delivering new technology to the market too quickly with inadequate data.
“In general, I like more freedom and more technologies for doctors because I believe that doctors only want the best for their patients. But regulations play an important role, too,” he said. “The question is, are we willing to take more risk for earlier access to technology? Or would we rather have less risk but wait longer and pay a higher cost to get it there?”
New regulation in Europe
With the new EU Medical Device Regulation, which went into effect in May 2021, the approval process for medical devices has become lengthier and more cumbersome, according to Auffarth.
“New regulations have been added to those already implemented by the Medical Device Directive. This has created some discontent because companies have to reapply for CE mark for special devices, even if they have been on the market for a long time, and some products that were previously in a different class are now classified as medical devices, requiring a new application. This is in some cases overregulated for simple things, for example like the Schirmer’s test strips,” Auffarth said.
Small companies are at a disadvantage in this situation because they cannot afford the financial burden of this large amount of regulatory work. Morcher, for instance, has put its small-aperture add-on IOL on hold.
“While the FDA has become a little more flexible to make the process faster in the past couple of years, European regulatory agencies have become more demanding, also in terms of post-marketing surveillance. However, I am quite sure this won’t disturb the innovation process in Europe in the long run,” Auffarth said.
The paradox of choice
In a symposium at the European Society of Cataract and Refractive Surgeons winter meeting, specialists discussed the issue of how to navigate the wide selection of IOLs currently available.
“With so many options, doctors may be confused and find it increasingly difficult to counsel patients. However, we are eye specialists, and this is our job,” Ribeiro said.
“We do have many options in the U.S., and it is our job to match the implant with the patient,” Hatch said. “We want to also be able to train residents and fellows how we make these decisions and guide patients through their cataract surgery journey.”
Selecting the appropriate IOL requires a multiple step discussion that starts with a thorough examination of the eye, including corneal topography, higher-order aberrations and measurement of the angle kappa.
“Issues with the eye such as higher-order aberrations or large angle kappa lead to a high risk for dysphotopsia with some lenses, so we need to select implants that will match the patient goals and optimize expectations. We need to guide patients through their journey. It is our job to select the implant that will ultimately give patients the vision they deserve in their lives. Often I bring patients back for a second appointment for additional testing and have a second discussion before finalizing the plan,” Hatch said.
Giving the patient information, and the time to digest it, runs in parallel with gaining information about the patient and understanding them better to make the best choice.
“The practices that are most successful with these technologies are the ones that really embrace the whole process,” she said.
Auffarth said that it is easier for physicians who are involved in studies to have a better grasp on a wide range of options.
“We get an idea of what is good, what is bad, what is important, what is an advantage, what does or does not make a difference. But if you are sitting in a solo practice somewhere in a small town, too many options can make you feel lost,” he said.
His advice in this case is to stick to two or three technologies and master them well, with an excellent IOL calculation method and a standardized approach.
“If you add to this an appropriate patient selection profile, then everything works. You just need to know which patients do not fall into your candidacy profile and honestly tell them you don’t have a choice for them,” he said.
According to Auffarth, most physicians, even those who have gained experience with a large number of different lenses, eventually stick to two or three models because they want to standardize their approach.
“However, when you have a patient who would not do well with those lenses, you have to find an alternative. In my clinic, I have several doctors applying premium lenses, and we split them among us. We specialize in specific models and use them constantly. In this way, we can offer a high level of expertise in more than 10 different types of premium IOLs,” he said.
Payment policies
In the United States, toric and presbyopia-correcting IOLs are not paid for by insurance or Medicare, and this system works well, according to Berdahl.
“If they were covered by insurance, it would be really tough on insurance companies, and the incentive for continued innovation from a marketplace standpoint wouldn’t be there,” he said. “Patients who believe that not having to wear glasses at all or as frequently invest in this choice. We want to have options for our patients, our patients deserve to know what these options are, and our obligation is to try and do what’s in their best interest.”
In Europe, reimbursement policies for cataract surgery, including IOLs, differ from country to country. In Portugal, there is a system of reference prices in the scope of reimbursement. Enhanced monofocals can be a game changer for the National Health System if the cost approaches monofocal standards, as is the case with the Eyhance IOL.
Germany has adopted a copayment system in which patients pay out of pocket the additional cost of the premium lens.
“This is a good approach, successfully adopted in several countries in Europe. However, it didn’t really have a huge impact on sales. In Germany, it increased the use of premium IOLs from approximately 6% to 8% to approximately 10% to 15% of the total. It doubled, but the absolute number is still quite low,” Auffarth said.
- References:
- Alio JL, at al. Surv Ophthalmol. 2017;doi:10.1016/j.survophthal.2017.03.005.
- Dick HB. Curr Opin Ophthalmol. 2019;doi:10.1097/ICU.0000000000000576.
- Donaldson KE. J Refract Surg. 2021;doi:10.3928/1081597X-20210408-03.
- Janetos TM, et al. Expert Rev Med Devices. 2018;doi:10.1080/17434440.2018.1539666.
- Kohnen T, et al. J Cataract Refract Surg. 2020doi:10.1097/j.jcrs.00000000000002-32.
- Moshirfar M, et al. Curr Opin Ophthalmol. 2021;doi:10.1097/ICU.0000000000000722.
- Rampat R, et al. Ophthalmology. 2021;doi:10.1016/j.ophtha.2020.09.026.
- Yeu E, et al. Ophthalmology. 2021;doi:10.1016/j.ophtha.2020.08.025.
- For more information:
- Gerd Auffarth, MD, PhD, can be reached at University Clinic of Heidelberg, Department of Ophthalmology, INF 400, Heidelberg, D-69120, Germany; email: gerd.auffarth@med.uni-heidelberg.de.
- John P. Berdahl, MD, can be reached at Vance Thompson Vision, 3101 W. 57th St., Sioux Falls, SD 57108; email: john.berdahl@vancethompsonvision.com.
- Kathryn M. Hatch, MD, can be reached at Mass Eye & Ear, 1601 Trapelo Road, Suite 184, Waltham, MA 02421; email: kathryn_hatch@meei.harvard.edu.
- Filomena Ribeiro, MD, PhD, can be reached at Hospital da Luz, Av. Lusíada 100, 1500-650 Lisbon, Portugal; email: filomenajribeiro@gmail.com.
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