December 2019

IN FOCUS

Examining presbyopia treatments
U.S. ophthalmologists start to experience trifocal IOLs


by Liz Hillman EyeWorld Editorial Co-Director

“….thus far, the patients in whom we’ve implanted this IOL since approval are thrilled with their results.”
—Robert Cionni, MD


PanOptix IOL implanted following cataract surgery.
Source: Eric Donnenfeld, MD

For years, ophthalmologists have been hearing about the success with trifocal IOLs from outside the U.S. With FDA approval of the AcrySof IQ PanOptix trifocal IOL (Alcon), U.S. ophthalmologists now are beginning to use this option, drawing confidence from experience reported overseas.
“What I appreciate the most is that because of the span of time that has passed where there has been availability internationally, it really gives us the breadth of what the international experience has been like,” Elizabeth Yeu, MD, said. “Right now the experience allows us to recognize that there is a reason this lens has taken over the market for multifocals overseas, where it has been a leader in the multifocal space. It gives me some greater confidence and trust that the lens technology works as it’s supposed to given the fuller range of vision.
“It appears that there are less bothersome dysphotopsias and very high quality of vision, and those are all things we’re thinking about when we’re thinking about any light-splitting technologies: 1) quality of vision, 2) range of vision, and 3) unwanted side effects,” Dr. Yeu said.
PanOptix is currently the only FDA- approved trifocal in the U.S. Bausch + Lomb is in the midst of a clinical trial with its enVista MX60EF trifocal IOL, enrolling its first patient for the 500-patient study in June 2018. Trifocals that are currently being used outside of the U.S., in addition to PanOptix, are the AT LISA (Carl Zeiss Meditec), FineVision (PhysIOL), and RayONE Trifocal (Rayner).
Dr. Yeu, Robert Cionni, MD, and Kerry Solomon, MD, who were involved with the PanOptix clinical trial, and Eric Donnenfeld, MD, shared their thoughts and experience with this technology coming to the U.S.

Significance of trifocals

Dr. Donnenfeld said the availability of trifocal lenses in the U.S. is important because it offers a different type of vision, a different option to patients.
“What we have in the U.S. are wonderful lenses that give great vision at distance, but not as good close up, and those include extended depth of focus (EDOF) and low-add multifocals,” Dr. Donnenfeld said, adding that patients might have the expectation that they wouldn’t need glasses for reading with these lenses and, as such, ophthalmologists have been “compromising our offerings to these patients” by offering high-add multifocals at the cost of distance vision with more glare and halo, mixing and matching lenses, and employing other techniques to enhance vision with available technologies.
“Trifocals give you the same reading that the high-add multifocals have, but it also gives you intermediate vision, and in my experience and international experience, they give better distance vision,” Dr. Donnenfeld, who has just been adding trifocals to his practice, said. “It really fills areas that are needed for presbyopia correction and that is intermediate vision and good quality of vision at distance.”
Dr. Solomon said he thinks trifocals bring a more full range of vision to the market. He also said it simplifies things. Before, he said, there would need to be conversations with the patients to determine what they wanted out of their lens—intermediate (computer/cellphone) vision or near (reading) vision—with compromises on one or the other.
“What the trifocal brings is the opportunity to really simplify the discussion. Do you want to be able to see distance and near? The trifocal, according to the U.S. data and speaking to our international colleagues, really provides a nice range of vision where people are able to see their computers and read without needing to be dependent on glasses,” Dr. Solomon said.
Dr. Cionni offered a similar point, saying that the same IOL model can be implanted in both eyes, improving results and making the preop discussion easier for the surgeon and more understandable for the patient.
Dysphotopsias, Dr. Yeu said, seem to be a lesser concern with the PanOptix trifocal technology, particularly because the overall range and quality of vision are excellent. She said it’s more of a ring-like halo, rather than streaking or starbursts, so it’s easier to describe to patients.

Considering candidates

A healthy macula and ocular surface are key for success with these lenses, the sources said. Dr. Yeu said she is still relatively stringent in selecting patients for PanOptix. She is not currently offering this lens to patients who have had prior refractive surgery because, she said, she’s in an early phase of using the technology.
Dr. Solomon had used PanOptix in one post-LASIK patient who was 2-weeks postop and doing well when EyeWorld spoke with him. While patients with prior refractive surgery were excluded from the FDA clinical trial and historically many U.S. surgeons have shied away from using multifocal lenses in these patients, he said the clinical experience in the U.S. with EDOF lenses and trifocals overseas in post-refractive patients is such that he felt confident doing so in a patient who didn’t have irregularities with their vision.
PanOptix is available as a toric, correcting up to 3 D of astigmatism (T3–T6 available). Dr. Solomon said he’ll pair a nontoric version with femtosecond arcuate incisions for lower amounts of astigmatism, and Dr. Yeu said she’ll do the same with a toric version for higher amounts of astigmatism.
In terms of setting expectations, Dr. Yeu said she feels looking at patient-specific considerations are less of an issue with these lenses. She still sets the expectation that patients will need extra magnification for extremely fine print or in poor lighting conditions, but Dr. Yeu said this conversation is more to cover her bases. Dr. Solomon said he also tells patients preoperatively that a presbyopia-correcting cataract surgery could be a two-part procedure: First to address the cataract and implant the lens and second to perform enhancements that might be necessary. He said enhancements occur in about 15% of premium IOL patients.

When to avoid trifocals

Dr. Cionni said that although it hasn’t been studied, it’s likely that patients with significant corneal aberrations would not be happy with multifocal, EDOF, or trifocal IOLs. Patients with RK and keratoconus, for example, would not be good candidates, he said.
On a similar vein, corneal abnormalities related to ocular surface disease and dry eye would need to be addressed prior to assessing candidacy for this lens, according to Dr. Solomon.
If a patient was very concerned about night vision symptoms, Dr. Yeu said she would consider the lowest-add multifocal or an EDOF IOL instead. Starting with a trifocal in the nondominant eye first is key in patients where dysphotopsias were of significant concern. See how they do postop, and treat the dominant eye accordingly.
Dr. Donnenfeld said if a patient wanted to have the best possible distance vision, good intermediate, and were willing to wear glasses for near, he would still recommend an EDOF lens. However, if their goal is overall spectacle independence at all distances, he said he would offer trifocal technology.

Tips for success

The doctors noted how forgiving PanOptix seemed to be when slightly off target. Dr. Solomon specifically mentioned the defocus curves of the clinical trial data as evidence and compared this flexibility to that seen with EDOF technology.
“Surgeons still need to be vigilant about getting refractive error as close to plano as they can,” he said, noting, however, that airing on the side of slightly hyperopic is yielding good results.
Dr. Yeu said she uses 119.1 as her A constant and the Barrett Universal for all axial lengths, comparing calculations with the Hill-RBF. She said she’ll start with the nondominant eye, aiming for the first minus of plano to nail both distance and range of near vision. In the dominant eye, she said she’ll aim for the closest to plano, even if it’s on the hyperopic side.
Dr. Solomon said he continues to under promise and over deliver with these lenses. He also emphasized the importance of good preop measurements. He takes at least two biometry measurements using different devices as well as a topography.
Overall, Dr. Cionni said he has been involved in many clinical trials for presbyopia-correcting lenses and has “never seen happier patients than I found with the patients I treated in the clinical trial.”
“We always have to be careful in translating trial results to post-market approval outcomes but, thus far, the patients in whom we’ve implanted this IOL since approval are thrilled with their results,” he said.

At a glance

• The first trifocal IOL to receive FDA approval was PanOptix (Alcon) in August 2019. The enVista trifocal IOL (Bausch + Lomb) is in clinical trials in the U.S.
• Surgeons report positive patient experience with PanOptix thus far with good range of vision at near, intermediate, and distance.
• They also report fewer dysphotopsias often associated with multifocal and extended depth of focus IOLs.
• There are characteristics that should be taken into account when considering a patient as a candidate for a trifocal IOL.

Contact information

Cionni: rcionni@theeyeinstitute.com
Donnenfeld: ericdonnenfeld@gmail.com
Solomon: kds@cepmd.com
Yeu: eyeulin@gmail.com

About the doctors

Robert Cionni, MD
Medical director
The Eye Institute of Utah
Salt Lake City

Eric Donnenfeld, MD
Ophthalmic Consultants of Long Island
Clinical professor of opthalmology
New York University
Garden City, New York

Kerry Solomon, MD
Carolina Eyecare Physicians
Mount Pleasant, South Carolina

Elizabeth Yeu, MD
Assistant professor of ophthalmology
Eastern Virginia Medical School
Virginia Eye Consultants
Norfolk, Virginia

Relevant financial interests

Cionni: Alcon
Donnenfeld: Alcon, Bausch + Lomb, Johnson & Johnson, Carl Zeiss Meditec
Solomon: Alcon
Yeu: Alcon, Johnson & Johnson Vision, Carl Zeiss Meditec

U.S. ophthalmologists start to experience trifocal IOLs U.S. ophthalmologists start to experience trifocal IOLs
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