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Digital Supplement | Sponsored by Alcon

PANOPTIX Trifocal IOL: What do US experts say?

Modern medicine increases life expectancy, as well as functionality well into retirement. The next generation of patients need more options to suit their individual visual needs. Dr. Elizabeth Yeu from Virginia Eye Consultants moderated a discussion with Dr. Bret Fisher, Panama City, Florida; Dr. Vance Thompson, Sioux Falls, South Dakota; and Dr. Robert Cionni, Salt Lake City, Utah, on the PanOptix Trifocal IOL, the latest addition to the presbyopia mitigation IOL landscape.

What are the needs of the cataract patient today and how can the refractive cataract surgeon meet these needs?

Elizabeth Yeu, MD: The refractive cataract surgeon of today is facing a new set of demands as patients continue to demand a greater range of vision. Distance vision is required for driving, near vision is required for reading the newspaper and other printed materials, and intermediate vision is jumping to the forefront, as it is what is required for computers, cellphones, and most digital tasks. We’re also seeing more patients who want to participate in lifestyle sports like golfing, swimming, and hunting without needing spectacles—all sports that require a range of vision. Until now, we have been able to offer our patients options for a combination of distance and near vision, but the intermediate range has generally been absent. It is no wonder that the penetration of presbyopia-correcting lens implants is only about 9%.1 How are we doing here in speaking to patients about their visual lifestyles?

Vance Thompson, MD: In today’s digital environment, everyone wants a full range of vision. Many people spend hours a day viewing computer screens, tablets, and other devices. Although patients may not recognize what the term “intermediate vision” means, we can easily identify the many tasks our patients perform each day to discover their needs. I often discuss hobbies, work, and social life to better understand what my patients do with their time and how I can best help them.

Bret Fisher, MD: As a physician, the first and most important thing is connecting with patients on more than just a superficial level. As surgeons, we are always looking for efficient and reproducible ways to make our patients happier. In our office we use questionnaires and staff to assist with efficiency, but nothing substitutes for the physician-patient relationship. At times this can feel like making a fine Swiss watch, with customization and mixing and matching lenses to meet their needs. There really hasn’t been an “easy button” for a wide range of vision.

What presbyopia-mitigating options have been available in the US previously, and what are the limitations?

Dr. Yeu: Currently, the options for the treatment of presbyopia at the time of cataract surgery are monofocal lenses with readers to supplement, bifocal diffractive, diffractive extended depth of focus (EDOF), and accommodative intraocular lenses. What limitations exist with each of these options?

Robert Cionni, MD: Bifocal intraocular lenses work by presenting simultaneous near and distance focal points to the retina. We’re finding that with each iteration of this concept, we are getting better results—but there is room for improvement. You can interview patients and ask them what they prefer: distance, intermediate, or near vision. Almost all will say, “Why can’t I have them all? And, if I have to wear glasses some of the time, why spend the extra money on a premium bifocal option?”

Dr. Thompson: The accommodating intraocular lens was the first model to offer patients the ability to see multiple distances, yet it limited their near vision. The diffractive EDOF IOL introduces an elongated focus for increased depth of focus and a range of vision from distance to intermediate. Yet, in order to achieve distance, intermediate, and near, we need to use some form of mild monovision to improve the near image.

What is the PanOptix Trifocal IOL?

Dr. Yeu: With trifocality, we have the ability to offer distance, intermediate, and near vision to our patients with a single IOL. The PanOptix Trifocal IOL has three focal points with near at 40 cm (16 inches); intermediate at 60 cm (24 inches); and distance (Figure 1). The lens allows 88% of light energy to be utilized at a 3-mm pupil size with a 50% directed to distance, 25% to intermediate, and 25% to near.2

Figure 1: The PanOptix Trifocal IOL with 3 focal points (40 cm, 60 cm and distance).

Dr. Cionni: The PanOptix Trifocal IOL has a 4.5-mm diffractive zone that is designed to be less dependent on lighting conditions. Patients are going to enjoy not only good distance vision, but good intermediate and near vision in most lighting conditions.

Dr. Yeu: Why are lighting conditions so important and how does the PanOptix Trifocal IOL help here, Dr. Thompson?

Dr. Thompson: The diffractive nature of the PanOptix Trifocal IOL is extremely important because it allows for better visual functioning that is less dependent on pupil size. A lot of patients will see well with a lot of multifocal technologies, but not always at low light. It is amazing how well patients see at both 40 cm and 60 cm under various light conditions and pupil sizes.

PanOptix Trifocal IOL clinical performance

Dr. Yeu: What results have we seen so far across the world with the PanOptix Trifocal IOL?

Dr. Thompson: What gave me great confidence in participating in the PanOptix Trifocal IOL clinical trial were the results outside of the United States by other surgeons. In one post-market, single-arm, clinical study, 149 patients were implanted bilaterally with the PanOptix Trifocal IOL.3 At 3 months postoperatively, the PanOptix Trifocal IOL consistently provided a visual acuity of 0.02 to 0.08 logMAR (approximately 20/25 or better). For many patients, 20/20 near, intermediate, and distance vision is now possible with PanOptix.

Dr. Yeu: Do those results correlate with what we have found here in the United States, Dr. Fisher?

Dr. Fisher: Absolutely. In the United States, a prospective, multicenter study evaluated the effectiveness and safety of the PanOptix Trifocal IOL in adults with less than 1.0 D of preexisting corneal astigmatism over a 12-month time frame.4 At 6 months postimplantation, the majority of patients achieved 0.1 logMAR or better (~20/25 or better) at all three distances combined (Figure 2).

Figure 2: Photopic binocular distance corrected visual acuity at 6 months postimplantation with PanOptix Trifocal IOL.4

DCVA = Distance Corrected Visual Acuity; DCIVA = Distance Corrected Intermediate Visual Acuity; DCNVA = Distance Corrected Near Visual Acuity.

Range of vision with the PanOptix Trifocal IOL

Dr. Yeu: What have you found at your specific study site?

Dr. Cionni: I have been involved in a lot of multifocal IOL studies. I can say that, along the way, most patients were very pleased with their results. However, the PanOptix Trifocal IOL outcomes really impressed me. Not only did my patients have great vision, but they had a great range of vision. I did not see patients moving back and forth to find the sweet spot without having to do any mini-monovision or mix and matching of IOLs.

Dr. Yeu: When it comes down to range of vision, we must take into account different lifestyles and activities. Do you agree?

Dr. Fisher: The visual acuity at which patients are happy is usually 20/25. The visual acuities at our site were impressive, with 100% of patients getting to that level.5 These were by far some of my happiest PCIOL patients. But the real litmus test I like to use are the hunters who tend to go out at dusk and dawn, when the light conditions are less than ideal. I can say, I have some very happy hunters with this lens.

Dr. Yeu: How does this relate to the defocus curve, and why is it important to evaluating a presbyopia-correcting lens?

Dr. Cionni: The range of vision as demonstrated by the defocus curve is an objective performance marker for an optic in this class. Defocus curves assist with understanding a presbyopia-correcting IOL’s range of vision. Patients are presented with a series of positive and negative loose lenses in front of their eye, and their visual acuity is assessed. The plot of their visual acuity against each dioptric value of a trial lens creates a defocus curve. The defocus curve for the PanOptix Trifocal IOL from +0.5 D to -2.5 D (i.e., from distance to 40 cm) demonstrated 20/25 or better from distance to 40 cm and anywhere in between (Figure 3).4

Figure 3. Binocular defocus curve of patients implanted bilaterally with PanOptix Trifocal IOLs (n=129 patients) and monofocal IOLs (n=111 patients).4

Dr. Yeu: Dr. Thompson, with regard to refractive targets, will you be performing monovision in your cataract patients with the PanOptix Trifocal IOL or will you target Plano-Plano?

Dr. Thompson: For some patients, the idea of having different lenses in each eye or having one eye under-corrected can be confusing. During the preoperative education in the clinical trial, I found it very intuitive to discuss having the same optic in each eye with a refractive target set for plano.

Dr. Yeu: Absolutely, and the PanOptix Trifocal IOL is also a forgiving lens for refractive errors. At +0.5 D, there is still excellent range of vision that includes good intermediate vision as well, with patients still being able to hit 20/20 at distance.

How does the PanOptix Trifocal IOL compare to other presbyopia-correcting intraocular lenses (PCIOLs)?

Dr. Yeu: How does this lens change patient counseling and education when compared to other multifocal technologies?

Dr. Cionni: The amount of time spent discussing lens options with patients, as well as which portion of vision is most important to them, can substantially decrease with the PanOptix Trifocal IOL. Patients can often become confused when taking the mix-and-match approach. I really think there will be fewer patients saying, “Why isn’t it working the way I wanted it to, Dr. Cionni?”

Dr. Thompson: I used to do a lot of mixing and matching because I’m trying to achieve good vision at all distances, but this approach has limitations. The Trifocal preoperative conversation is easier because it is intuitive for patients to have the same lens implanted into each eye.

Dr. Yeu: Ultimately it is all about patient satisfaction, but surgeon satisfaction is also a key factor. Having a high level of confidence that the lens we implant will deliver good results is very important—not only in the range of acuity, but also in the quality of vision without issues at distance, intermediate, or near.

Patient reported outcomes with PanOptix Trifocal IOL

Dr. Yeu: Diffractive optics are known to have a greater potential for night vision disturbances simply by design, as compared to nondiffractive optics. I was very pleased to hear my patients’ comments in this area were that it didn’t disrupt their ability to drive or perform other activities at night. Dr. Fisher and Dr. Thompson, do you agree?

Dr. Fisher: When looking at mesopic and photopic conditions, my patients were uniformly happy with the performance of this lens overall, given varying lighting conditions.

Dr. Thompson: Although light is split more with this lens, I found myself pleasantly surprised by its results. I thought that the more light that is split into different focal points could equate to more nighttime glare and halo, but this wasn’t my experience. We did not treat any residual astigmatic refractive error. To see results this good right out of the gate is impressive.

Dr. Yeu: That’s correct. We did not treat any residual astigmatic or refractive error in the US registration study based on the clinical protocol, which, if present, can lead to more spherical aberration and greater night vision photopsia. The mean residual refractive cylinder in the study was 0.4 D on average at 6 months postoperatively.

Contrast sensitivity (photopic/mesopic) with and without a source of glare was also tested. Mean contrast sensitivity was similar between PanOptix Trifocal IOL and a monofocal IOL across all conditions and sources of glare with a mean maximum difference of < 0.11 log units between the two groups (Figure 4), which is below the level of clinical significance (0.3 log units).5

Figure 4. Photopic and mesopic contrast sensitivity at 6 month postimplantation.4

Dr. Yeu: How did the lens fare in regard to visual disturbances in your opinion, Dr. Cionni?

Dr. Cionni: In a validated questionnaire developed by Alcon to study visual disturbances, starbursts and halos were reported in higher proportions in patients implanted with PanOptix Trifocal IOL versus the monofocal IOL, as anyone would expect with a diffractive optic. However, a majority reported these symptoms as “not bothersome at all.”4 Even though patients report visual disturbances, many also said these effects are not bothersome, or minimally bothersome.

Dr. Yeu: How did the PanOptix Trifocal IOL do with respect to patient satisfaction?

Dr. Fisher: I was delighted with the results. Satisfaction was very high, with appropriate patient selection, 99.2% of patients studied stating they would implant the same lens again.4

Figure 5. Patient reported visual phenomena at 6 months postimplantation addressing the bothersomeness of starbursts, halos, and glare.4

Summary

Dr. Yeu: With the PanOptix Trifocal IOL, 20/20 near, intermediate, and distance vision is now possible. The lens works in multiple lighting conditions, which is very powerful for our patients. The lens will also be powerful for surgeons and easy to adopt. Although other lens modalities exist in the presbyopia-correcting landscape, this is the first FDA-approved trifocal lens and provides high patient satisfaction despite visual phenomena that can happen in all diffractive lenses. The PanOptix Trifocal IOL is an innovative lens and effective when used as intended. It provides exceptional vision at distance, intermediate, and near while preserving contrast sensitivity. Lastly, all of this can be achieved with a single lens, without the complexities of mini-monovision or mixing and matching of PCIOLs.

© 2019 Alcon Inc.11/19 US-ACP-1900160

PanOptix is a trademark of Alcon. All other brand/product names are the trademarks of their respective owners.

Roundtable participants are paid Alcon consultants

1. Sixth Annual ASCRS Clinical Survey. http://supplements.eyeworld.org/eyeworld-supplements/december-2018-clinical-survey. Accessed August 15, 2019.

2. Kohnen T. First implantation of a diffractive quadrafocal (trifocal) intraocular lens. J Cataract Refract Surg. 2015;41(10):2330-2332.

3. Kohnen T, Martinez AA. Multicenter visual outcomes evaluation of a novel trifocal presbyopia-correcting IOL. Presented at: ESCRS. Sept. 2018, Vienna, Austria.

4. AcrySof IQ PanOptix Trifocal IOL, Model TFNT00 DFU.

5. Fisher B. Cumulative visual acuity of a novel trifocal IOL. Presented at: ASCRS. May 2019, San Diego, CA, USA.

author
Elizabeth Yeu, MD (moderator)
  • Virginia Eye Consultants, Virginia Beach, Virginia
  • eyeu@vec2020.com
  • Financial disclosures: Consultant to Alcon.
author
Vance Thompson, MD
author
Bret L. Fisher, MD
  • The Eye Center of Panama City, Panama City, Florida
  • bfisher@eyecarenow.com
  • Financial disclosures: Consultant to Alcon.
author
Robert Cionni, MD

AcrySof®IQ PanOptix®Family of Trifocal IOLs

IMPORTANT PRODUCT INFORMATION

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.

The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert® IOL Injector Handpiece is indicated for use with the AcrySof® lenses SN6OWF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

INDICATIONS: The AcrySof®IQ PanOptix®Trifocal IOLs include AcrySof®IQ PanOptix®and AcrySof®IQ PanOptix®Toric and are indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients, with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL. In addition, the AcrySof®IQ PanOptix®Toric Trifocal IOL is indicated for the reduction of residual refractive astigmatism.

WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia and ensure that IOL centration is achieved. For the AcrySof®IQ PanOptix®Toric Trifocal IOL, the lens should not be implanted if the posterior capsule is ruptured, if the zonules are damaged or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation. Some visual effects may be expected due to the superposition of focused and unfocused multiple images. These may include some perceptions of halos or starbursts, as well as other visual symptoms. As with other multifocal IOLs, there is a possibility that visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. A reduction in contrast sensitivity as compared to a monofocal IOL may be experienced by some patients and may be more prevalent in low lighting conditions. Therefore, patients implanted with multifocal IOLs should exercise caution when driving at night or in poor visibility conditions. Patients should be advised that unexpected outcomes could lead to continued spectacle dependence or the need for secondary surgical intervention(e.g., intraocular lens replacement or repositioning). As with other multifocal IOLs, patients may need glasses when reading small print or lookingat small objects. Posterior capsule opacification (PCO) may significantly affect the vision of patients with multifocal IOLs sooner in its progression than patients with monofocal IOLs. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure, available from Alcon, informing them of possible risks and benefits associated with the AcrySof®IQ PanOptix®Trifocal IOLs.

ATTENTION: Reference the Directions for Use labeling for each IOL for a complete listing of indications, warnings and precautions.