March 2021

CATARACT

What’s new in the world of IOLs


by Liz Hillman Editorial Co-Director

 

New optical qualities, new materials, preloaded inserters, and the possibility of accommodative abilities: There has been quite a bit of movement in IOL innovations, some of which are available in the U.S., while others are still on the horizon.

New optics

While there has been a push toward presbyopia correction with IOLs, more recently quality of vision at distance has come into focus, said Cathleen McCabe, MD.
“That’s been a trend with low-add multifocals, getting away from the original concept that if we were going to offer a premium service that it had to be great near and that it was OK to sacrifice quality of vision at distance or to accept unwanted visual disturbances,” she said, adding, “What we see now is that the quality of some of the offerings we have to extend the range of vision has improved to such a level that they may seriously compete with a monofocal lens for a wider variety of patients.”
One such lens is the AcrySof IQ Vivity (Alcon). Vivity was FDA approved in February 2020 and began a commercial rollout later in the year. Vivity is a non-diffractive lens offering extended range of vision with, according to the company and anecdotal reports from physicians who have implanted it, a low incidence of visual disturbances.
Dr. McCabe was involved in the FDA trials for Vivity and has used it since its commercial launch. She said this lens design gives her more confidence that she will have a happy patient postop. She has found it allows her to extend presbyopia correction as an option to more cataract patients than she previously would have.
“For me, it’s the peace of mind knowing that if I put a Vivity lens in, my risk of having that patient complain about glare, halos, or starbursts is the same as if I put a monofocal lens in. I’m not worried that in the future the patient will come in and I’ll think to myself ‘I wish I hadn’t put this technology in,’” she said.
It’s also been helpful in her consideration of patients who tend to be more exacting about their quality of vision or those who are on the fence in terms of eye health.
“The increased comfort level of the decision making is one of the biggest things with Vivity. When they’re paying extra, patients expect to have an extended range of vision and have independence from their glasses, and they expect to not have visual disturbances. Patients are thrilled because the postop experience is what they expected anyway. Surgeons are thrilled that they did not have to do all those additional mental risk-benefit calculations preoperatively so that their patients could receive those benefits,” she said.
Arthur Cummings, MD, who has had experience with Vivity since January 2020, said that the lens is uniquely forgiving.
“Even if the lens is decentered significantly, you’re not going to get glare and halo, and even if you’re off target up to –1 in one eye, you’re not going to get glare and halo,” Dr. Cummings said, explaining that –0.5 to –0.75 of anisometropia seems to further extend depth of focus ability and functional near vision for the patient.
Dr. Cummings thinks the forgiving nature of this lens will encourage more ophthalmologists who previously shied away from the presbyopia- correcting lens market to enter.
“This lens will help grow the market,” he said. “People who never before considered themselves to be refractive cataract surgeons are going to start using it.”
Other lenses not yet available in the U.S. are the Tecnis Synergy (Johnson & Johnson Vision) and LuxSmart (Bausch + Lomb). Synergy (currently available in Europe, Australia, New Zealand, and Canada) is described as a continuous range of vision IOL that provides high-contrast vision even in low light. It has violet light-blocking technology to reduce halos. LuxSmart is a preloaded IOL that gives extended depth of focus with violet filters.
Another option, Tecnis Eyhance (Johnson & Johnson Vision), which recently became available in the U.S., fits in the monofocal category. Sumit “Sam” Garg, MD, thinks the approach with Eyhance is interesting, though he thinks both Eyhance and Vivity will have dysphotopsias to some extent and, as before, the expectation for these should be set with the patient preoperatively. (For more on Eyhance, see page 46.)
Synergy, Dr. Garg said, mixes multifocal and extended depth of focus technologies, and he thinks it will do well overall.
“It gives similar range, maybe better range, than a trifocal,” he said.
Eric Donnenfeld, MD, said that even though they’re a year or two old now, PanOptix (Alcon) and Tecnis Symfony (Johnson & Johnson Vision) should be mentioned as well.
“Symfony has a great range of vision with minimal distance problems,” he said.
Dr. Donnenfeld discussed a combination of Vivity in one eye and PanOptix in the other giving better spectacle-free near vision than Vivity alone and better clarity and distance vision than PanOptix alone.
“If I want to have the best chance of having complete spectacle independence, PanOptix would still be the lens to choose,” he said, noting that Vivity is better for patients who don’t want to compromise distance vision in any way.
Dr. Donnenfeld also mentioned iPure (BVI), which is a preloaded IOL that provides high contrast in low light and depth of field. According to BVI’s website, the lens is a monofocal that is designed to “maintain natural corneal depth of focus.”
The IC-8 (AcuFocus) and XtraFocus (Morcher) are pinhole IOLs, currently approved for use outside the U.S. Dr. McCabe said she thinks this type of technology will be important to address aberrated corneas.
“We don’t have anything else to help in that area, which is why I think it’s a unique solution for us in the future,” she said.

Adjustable IOLs

The ability to adjust refraction postop, allowing patients to experience their vision for a time and change it, if necessary, before it’s locked in is currently available in the U.S. with the Light Adjustable Lens (LAL, RxSight).
Though it’s been available for more than a year, John Vukich, MD, thinks there is still an education gap with this lens option.
Dr. Vukich has been working with the LAL for more than a year and said it has become his predominant premium IOL.
Other options in the works for adjustability of lenses include refractive index shaping and modular IOLs. Perfect Lens is a company working on the former technique, which uses a femtosecond laser to induce a change in the refractive index of an IOL’s material. Some modular IOLs, which consist of a stationary base and an exchangeable optic, are making advances outside the U.S., such as Harmoni (Alcon), as well as in development, such as the Precisight Lens (InfiniteVision Optics).
Dr. Vukich thinks adjustable lenses, like the LAL, can help grow the premium IOL market. Despite upgrades to premium IOLs in terms of performance, the adoption of presbyopia-correcting IOLs is about 15%, he said.
“The fundamental reason for that is there has never been a lens with a refractive outcome in mind that has a zero enhancement rate. There is always going to be a small percentage of individuals who will need to have a touch-up or some adjustment to achieve a desired result and to achieve satisfaction, which is critical for someone who has become a consumer, in addition to being a patient,” Dr. Vukich said, explaining that he thinks this is a major disincentive among ophthalmologists for adopting these lenses.
From a patient perspective, the adjustments afterward are just part of the procedure and they understand this up front, whereas enhancements, even when discussed preop, can be seen as a complication by patients.
“[The LAL], in my opinion, creates the opportunity for every cataract surgeon to be a refractive cataract surgeon. All of those other things that are barriers to entry or disincentives to participate or challenges that are created with other lenses are simply not present with the LAL,” Dr. Vukich said.
Some surgeons, though lauding the LAL technology, have not found it essential to their practice. Dr. Cummings, for example, said his enhancement rate is so small, and with access to an excimer laser for these enhancements, it doesn’t make sense to bring in the LAL, which requires more intense follow-up and essential patient compliance. Dr. Donnenfeld offered a similar perspective, citing his low enhancement rate. For a small group of patients and those who really desire accurate outcomes, he said it is a good option.

Accommodative

The IOL holy grail is a lens that functions like an emmetropic 20-year-old’s with accommodative abilities. While much work is being done toward this goal, nothing has quite met the mark.
“I think aside from tuning the distance vision perfectly, being able to have that smooth transition from distance to near that happens with your intention to focus at different distances would be fabulous,” Dr. McCabe said. “I think there are many great ideas being put forward. There [are] just always challenges and compromises that come with these designs. I don’t know what will rise to the top of this, but I think we want to continue to innovate in those areas.”
There are many different approaches being looked at. Juvene (LensGen) is a two-part IOL that works off a biomimetic principle to shift fluid to direct accommodation, Dr. Donnenfeld said, adding that data shows the majority of patients achieve 20/20 or better at distance, 20/25 at intermediate, and 20/40 at near.
There are a number of other accommodative IOLs at different stages of development. FluidVision (Alcon) is an IOL that uses the ciliary body’s existing accommodation to move fluid in and out of different areas of the IOL. Tek-Clear Accommodative Lens (Tekia) also takes advantage of the eye’s ciliary body with a haptic-optic design that bends with this muscle movement. Tekia calls this a “bending-beam” approach. ForSight Labs is creating Opira, which according to a company presentation at the 2019 Ophthalmology Innovation Summit, is a sulcus-based lens with haptics fixated in the capsulorhexis that uses the ciliary body to create a “dynamic anterior surface.” Lumina (AkkoLens) is composed of two progressive, flexible optics and is fixated in the ciliary muscle. The company stated that the amount of accommodation achievable depends on the existing strength of the ciliary muscle. Atia Vision Modular Presbyopia Correcting IOL (Atia Vision) has a stationary refractive optic and an accommodative base that is driven by the ciliary muscle. TetraflexHD (Lenstec) is approved outside of the U.S. and features a slightly angled lens with haptics that flex as the ciliary muscle moves. In a departure from accommodating IOLs that work with the existing ciliary muscle, Alcon is working with Verily, a subsidiary of the Google-connected Alphabet, to develop an electronically driven IOL. Finally, Crystalens (Bausch + Lomb), which is approved in the U.S., was among the first in the category of accommodative IOLs to make it to market.
Dr. Cummings said he thinks accommodating IOLs will make it to the market, but he admitted that it will take some time.
“Will they replace all IOLs? I don’t think so. It depends on the cost, size of the lens, how easy it is to insert the lens. I think the biggest challenge to accommodating IOLs is how well the other [advanced technology] IOLs have come along. … You’ll have to go over and above with an accommodating lens to justify.”

New materials

While companies are constantly working on IOL innovations, one area that doesn’t see change very often is IOL material. One recent innovation that has been getting attention by ophthalmologists on the material front is Clareon (Alcon, not yet available in the U.S.).
Dr. Cummings described the Clareon material as “pristine” with no glistenings.
“I think it surprised everyone how good this lens is. Everyone I know who is using it loves it. I think it’s the highest quality lens that Alcon has produced,” he said.

More preloaded IOLs

There has also been a push for more preloaded IOLs. Clareon, for example, comes as a preloaded IOL with the company’s AutonoMe delivery system. AutonoMe is an automated (gas-driven), single-use IOL delivery system.
“You’ve got amazing control of the delivery,” Dr. Cummings said of the system, adding that the Clareon material coupled with this delivery system makes it “the nicest lens I’ve used.”
Most other major IOL manufacturers have been adding to their portfolio of preloaded IOLs in recent years as well. Dr. Donnenfeld said preloaded IOLs have an added level of stability and safety and make it easier on staff to transfer the lens to the surgeon.
The quality and ease of the inserter, according to Dr. Cummings, can be an influential factor in use of the IOL.
“In other parts of the world, I’ve heard of surgeons switching to a particular brand of IOL because the range has the same inserter. … Once you find an inserter that works well for you, it’s easier, more repeatable,” Dr. Cummings said.
Despite updates in the IOL market to improve range of vision, optical quality, and ease of use, the physicians interviewed for this article emphasized that tailoring IOL decisions to patient needs and setting appropriate expectations will continue to be important.
“We’re going to have more in-depth conversations with patients and do more thorough preop evaluations, looking for patients who are good candidates and evaluate the distances achievable with these lenses,” Dr. Donnenfeld said. “I think that with all these options, we need to determine which patient parameters are best for these lenses and consider demands for quality of vision versus quantity.”
“At the end of the day, it still comes down to picking the right technology for your patient and making sure they understand there is no perfect lens, and every lens has a positive and a drawback and that you discuss that with them,” Dr. Garg said. “Do I hope we’ll have a perfect lens for all patients one day? I do. Do I think we’ll ever actually get there? I don’t. I think we’ll still need to make sure we’re picking the appropriate technology for the patient.”

There has been quite a bit of movement in IOL innovations, some of which are available in the U.S., while others are still on the horizon.

About the physicians

Arthur Cummings, MD
Wellington Eye Clinic
Dublin, Ireland

Eric Donnenfeld, MD
Ophthalmic Consultants of Long Island
Garden City, New York

Sumit “Sam” Garg, MD
Gavin Herbert Eye Institute
University of California, Irvine
Irvine, California

Cathleen McCabe, MD
The Eye Associates
Sarasota, Florida

John Vukich, MD
SSM Health Davis Duehr
Dean Eye Care
Madison, Wisconsin

Relevant disclosures

Cummings: Alcon, RxSight, Vivior
Donnenfeld: Alcon, BVI, Johnson & Johnson Vision, LensGen
Garg: Alcon, Johnson & Johnson Vision, LensGen
McCabe: Alcon, Bausch + Lomb, Carl Zeiss Meditec, Johnson & Johnson Vision
Vukich: AcuFocus, Johnson & Johnson Vision

Contact

Cummings: abc@wellingtoneyeclinic.com
Donnenfeld: ericdonnenfeld@gmail.com
Garg: gargs@hs.uci.edu
McCabe: cmccabe13@hotmail.com
Vukich: javukich@gmail.com

Experience with a new next generation monofocal IOL

Johnson & Johnson Vision announced FDA approval and subsequent commercial launch of the TECNIS Eyhance and TECNIS Eyhance Toric IOLs in early February. These next generation monofocal IOLs are said to provide good distance vision and offer some patients extended intermediate and near vision.
Douglas Koch, MD, implanted the first Eyhance IOLs outside of the clinical trial in the U.S. and shared his thoughts and experience thus far. “[These IOLs are] exciting because they give superb quality of distance vision with no increased glare, and they provide patients, on average, with an additional line of intermediate and near vision,” Dr. Koch said.
When he spoke with EyeWorld, he had just implanted four Eyhance IOLs. Three of his patients were targeted for distance; on postop day 1, uncorrected acuities were 20/20, J2 intermediate for two and 20/25 J5 intermediate for the third. The fourth patient was targeted for –0.75 and was 20/30 and J2 near on postop day 1.
These results, Dr. Koch said, “are consistent with what we know about this lens from the optical bench data and the feedback from our European colleagues—that it truly expands the depth of focus.”
One study Dr. Koch thought was particularly powerful was by Auffarth et al., who reported that significantly more Eyhance patients had no difficulty with seeing to walk on uneven surfaces compared to monofocal controls (ZCB00, Johnson & Johnson Vision).1
“With standard monofocal IOLs, some patients targeted for distance can see their cellphone and computer. Eyhance will increase this number significantly,” Dr. Koch said.
He also highlighted the larger landing zone with this IOL.
“We may find a higher percentage of patients hit 20/20 or 20/25 uncorrected for distance as well. There is about a half diopter landing zone, which is larger than with standard monofocal designs,” Dr. Koch said.
How does Eyhance achieve these outcomes? Dr. Koch said the lens has a continuous aspheric
surface for gradual steepening in the center without specific zones.
Dr. Koch said that IOL calculations with this lens are the same, with the same A constant as the ZCB00. When it comes to aiming for a lens that goes to –0.4 D or –0.1, he said he would pick the latter more frequently with Eyhance. Dr. Koch doesn’t see any conditions as contraindications with this lens.
“I am going to be comfortable implanting this in my patients with ocular pathology because the quality of vision is superb. There isn’t the compromise of dividing the light as you would see with any of the extended depth of focus or multifocal/trifocal designs,” he said.
Eyhance is billed as a monofocal lens, which means it doesn’t cost the patient out of pocket, Dr. Koch said.

Reference

1. Auffarth G, et al. Clinical evaluation of a new monofocal IOL with enhanced intermediate function in patients with cataract. J Cataract Refract Surg. 2021;47:184–191.

Relevant disclosures

Koch: Alcon, Carl Zeiss Meditec, Johnson & Johnson Vision

Contact

Koch: dkoch@bcm.edu

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