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Digital Supplement | Sponsored by Alcon

PANOPTIX Trifocal IOL: What do Global experts say?

Evolution is continuous in all things, and the science of cataract surgery is no exception. Every time results improved, patients and surgeons themselves demanded to see how outcomes could be even better. In light of the approval of the PanOptix Trifocal IOL (Alcon) in the United States, several cataract surgeons with clinical experience using the PanOptix Trifocal IOL participated in a roundtable. Rosa Braga-Mele, MD; Marius Scheepers, MD; Jeff Horn, MD; Jerry Hu, MD; and Thomas Kohnen, MD, PhD, discussed patient needs from both the patient and the surgeon perspective, available IOL options to mitigate presbyopia, and the global experience with the PanOptix Trifocal IOL.

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

Rosa Braga-Mele, MD: When we ask ourselves what our patients need, we must understand their expectations, which have been shaped by multiple factors. Digital access to medical information has produced a well-informed patient generation with high expectations for their health and treatment options. Patients today have these higher expectations because they are often paying out-of-pocket costs for health care, prompting patients to expect more than the good distance vision afforded by monofocal IOLs. The digital era has also created a generation with increased demand for intermediate vision. Patients expect clear vision at distance, but also want to see their computers and tablets, as well as be able to read a book in most lighting conditions. This brings us to the question: How do we best meet the needs of these patients?

Jerry Hu, MD: Twenty years ago, the visual outcomes after cataract surgery were good, and patients were happy. Today, we are doing an even better job, yet some patients seem not as happy. I think this is because the bar of patient expectations has risen so high that it has become a different ballgame. We deliver outstanding outcomes, but we are defined by the outcomes of the most challenging cases. As eye care providers, we must offer a solution that provides a range of vision to meet these higher patient expectations.

Marius Scheepers, MD: To meet our patients’ expectations, we must listen to their needs and provide resources and comprehensive education. We have a responsibility to inform our patients about all lens options available, and we are very fortunate to have technologies available to us that mitigate presbyopia and provide patients with good vision at multiple working distances. However, we must select the right implant for each patient because there is no single solution that is good for everyone.

Dr. Braga-Mele: The bottom line is that we need to educate ourselves and then provide our patients with true informed consent for all the options that are available.

What presbyopia-mitigating options and approaches exist in the United States, and what are the limitations?

Dr. Braga-Mele: We’ve been able to offer presbyopia-correcting intraocular lenses (PCIOLs) for well over a decade. We have also seen a definite progression in premium IOLs over those 10 years. However, a 2018 ASCRS survey of US surgeons indicated only a 9% market penetration of PCIOLs.1 We need to figure out how we can improve this statistic. What are the current presbyopia-mitigating options in the United States?

Dr. Hu: There are a number of available technologies. The pseudo-accommodating IOL was the first generation of PCIOLs. The lens was designed to move anteriorly or posteriorly depending on the accommodative forces of the eye, thus providing distance and some intermediate vision. However, this technology has not been widely adopted because this lens type provided limited near and intermediate vision improvements.

The multifocal IOL splits light energy into two focal points. The two focal points are simultaneously presented to the retina providing distance and near or intermediate vision, depending on the add power. Essentially, we are talking about bifocal implants, which consequentially require patients to choose between having near or intermediate vision.

The extended depth of focus (EDOF) IOL introduces an elongated depth of focus and a range of vision from distance to intermediate. Yet, in order to achieve both functional distance and intermediate vision, we typically need to use some form of monovision to widen the depth of focus.

What other approaches exist to provide a range of vision to our patients?

Dr. Braga-Mele: Trifocal IOLs are the latest addition to the global PCIOL landscape. Trifocal IOLs produce a range of vision by splitting light energy into three focal points: near, intermediate, and far. Different optical approaches can be used to achieve trifocality in an IOL. Dr. Horn, would you elaborate more on the distinct features of each optical approach and what it means to the patients?

Dr. Horn: One way to achieve trifocality is to use the principal of sequential diffractive optics. Sequential diffractive optics creates an intermediate focal point that is located at 2 times the distance of the near focal point. For example, if the near focal point is at 40 cm, then intermediate is located at 80 cm (Figure 1). However, the most common intermediate vision activities are performed at arm’s length, or about 60 cm for the average height person.2,3

Figure 1. One approach to achieve trifocality is the application of sequential diffractive optics. This is used with traditional trifocal IOLs.

Dr. Braga-Mele: How do we get to an intermediate focal point of 60 cm?

Dr. Horn: Using the principal of sequential diffractive optics, one would need to place the near focal point at 30 cm to achieve an intermediate of 60 cm, which may be too close for the vast majority of patients. We simply cannot outrun physics, and we need a way around the limits of sequential diffractive optics. A way around the challenge is to use the non-sequential diffractive order approach, which leads to four focal points: a near at 40 cm, a first intermediate at 60 cm, a second intermediate at 120 cm, and distance (Figure 2). However, creating four foci may negatively impact distance performance. The far intermediate foci at 120 cm was redirected to distance which preserves an excellent distance performance. The result is a near foci at 40 cm, intermediate at 60 cm and distance, thus creating a way around sequential diffractive optics to optimize intermediate performance, while maintaining excellent near and distance performance of the IOL. This design is ENLIGHTEN technology (Alcon).

Figure 2. A theoretical IOL with four focal points (40 cm, 60 cm, 120 cm and distance) may not provide sufficient light energy for distance, possibly effecting distance vision performance, however when the 120-cm focal point is redirected to distance, you get ENLIGHTEN technology.

The PanOptix Trifocal IOL utilizes 88% of the usable light energy at a 3-mm pupil size, which is higher than the ReSTOR multifocal IOLs (Alcon).4 The 4.5-mm diffractive zone with ENLIGHTEN technology is designed to be less dependent on pupil size or lighting conditions. The PanOptix Trifocal IOL (Figure 3) allocates 50% of the available light to distance, 25% to intermediate, and 25% to near.5

Figure 3. The PanOptix Trifocal IOL with ENLIGHTEN technology has three focal points (40 cm, 60 cm, and distance).

PanOptix Trifocal IOL performance

Dr. Braga-Mele: The PanOptix Trifocal IOL has been investigated in a number of published studies. The lens received CE mark in Europe in 2015 and became available in Canada in 2017. I have personally been using the PanOptix Trifocal IOL since 2017. Dr. Kohnen, being the first surgeon to implant the PanOptix in the world, can you share some of the visual outcomes that patients may experience with PanOptix Trifocal IOL implanted in both eyes?

Prof. Kohnen: A post-market clinical study conducted across 17 sites in Europe, Latin America, and Australia demonstrated that, at 12 months postoperatively, the PanOptix Trifocal IOL consistently provided a visual acuity of 0.02 to 0.08 logMAR (approximately 20/25 or better) under uncorrected and distance-corrected conditions at distance, 60 cm, 80 cm, and 40 cm, with an overall postoperative spherical equivalent of -0.34 D ± 0.36 (Table).7

Range of vision with the PanOptix Trifocal IOL

Dr. Braga-Mele: Dr. Horn, can you talk about the range of vision with the PanOptix Trifocal IOL?

Dr. Horn: We looked at the defocus curve of 134 patients, who were implanted bilaterally with the PanOptix Trifocal IOL (Figure 4).7 A defocus curve assesses the visual performance of an IOL that is designed to provide a number of foci. To obtain a defocus curve, both eyes of a patient are fully distance corrected, and a series of positive and negative powered lenses are placed in front of the patient bilaterally to simulate different distances. At each simulated distance, the visual acuity of the patient is measured, which is plotted as the defocus curve. For example, a -2.5 D lens placed into a trial frame simulates how the patient will see at 40 cm or 16 inches.

When we look at the PanOptix Trifocal IOL defocus curve (Figure 4), we see a relatively flat curve that extends even beyond infinity (0 Diopter, D). It’s really quite remarkable.

Figure 4. Binocular distance-corrected defocus curve at 6 months postimplantation with PanOptix Trifocal IOL of n = 134 eyes as assessed in a prospective, single-arm study.7

Dr. Hu: I was a clinical investigator in the PanOptix Trifocal IOL US registration study, and in my experience from the trial, I noticed that my patients can read very well, even in dim light at near and intermediate ranges.10 This may be attributed to the allocation of available light, with 50% dedicated to distance vision, and then 50% equally divided between intermediate (25%) and near (25%).

How does the PanOptix Trifocal IOL compare to EDOF IOLs?

Dr. Braga-Mele: The clinical defocus curve assessment by Cochener et al.9 indicates that when the diffractive EDOF and PanOptix Trifocal IOL defocus curves are superimposed on each other at the near vision range, PanOptix remains above 20/25, whereas the diffractive EDOF lens tapers down to 20/40 as we progress closer toward the near focal point of 40 cm.* Could you expand upon the range of vision of the PanOptix Trifocal IOL versus a diffractive EDOF?

Dr. Hu: There are important differences between the defocus curve for the diffractive EDOF IOL and PanOptix Trifocal IOL. With diffractive EDOF, intermediate and distance is at an appropriate level but drops off after 50 cm. On the other hand, the defocus curve for the PanOptix Trifocal IOL is wider and steadier. On the near end, even as you bring the focal point to 16 inches (40 cm), visual acuity is still above 20/25 (Figure 4). With PanOptix, 20/20 near, intermediate, and distance vision is now possible.

Prof. Kohnen: Defocus curve studies comparing the diffractive EDOF IOL to the PanOptix Trifocal IOL have all shown that, in the range from intermediate to near, there is a decline of one to two lines of visual acuity with the diffractive EDOF IOLs.9,11,12 For some of my patients, diffractive EDOF technology is used, but only in certain patients with the right expectations about spectacle wear postoperatively. Some of the EDOF patients will still require +1 to +1.5 diopter reading glasses to read a book.

Dr. Hu: I learned how to successfully incorporate monovision and mix-and-match approaches with multifocal or EDOF IOLs. My go-to approach was to implant the ReSTOR 2.5 D with ACTIVEFOCUS design (Alcon) in the dominant eye and a ReSTOR +3 D in the nondominant eye. When I participated in the PanOptix Trifocal IOL US registration study, I was both pleasantly surprised and encouraged. Based on my experience, with the PanOptix Trifocal IOL I am able to deliver excellent near, intermediate, and distance vision without having to mix and match IOLs.10 I love the simplicity of PanOptix.

Prof. Kohnen: I would like to elaborate on this a little bit. With multifocal IOLs, one can mix and match to close the intermediate vision gap as seen in the defocus curves. We were just studying the mix-and-match approach with bifocal IOLs in Europe when trifocal technology came to the market. We immediately stopped the mix-and-match approach because we simply do not need it anymore. It is so much easier to put the same IOL in both eyes with full distance correction than to try and figure out eye dominance, distance power off-sets, or which add powers to use in each situation. I am careful to tell patients who are considering diffractive EDOF lenses that they are likely to need reading glasses. For our patients who demand near, intermediate, and distance vision, we use trifocal technology. The PanOptix IOL is expected to offer the benefit of increased freedom from the need of spectacles or contact lenses, at a range of near to distance vision.

Dr. Braga-Mele: I used the mix-and-match approach for about six months. Once the PanOptix Trifocal IOL came out, I also found it was no longer necessary to complicate my decision making with mix-and-match approaches. With the PanOptix Trifocal IOL, you don’t have to think through and speculate as to which IOL power was the best choice for the nondominant eye.

Dr. Scheepers: It is so much easier to implant the same lens in both eyes because, when patients have different lenses in each eye, they tend to compare and complain more about halo or differences in acuity. This does not happen when we have the same lenses in both eyes.

Patient-reported outcomes with the PanOptix Trifocal IOL

Dr. Braga-Mele: All of this leads us to the patient perspective. Dr. Scheepers, can you talk to us about patient outcomes with respect to the need for spectacles after PanOptix Trifocal IOL implantation?

What data do we have on patient reported outcomes?

Dr. Scheepers: If we look at the study by Akman and colleagues,14 they reported that 48 patients implanted bilaterally with PanOptix Trifocal IOLs had a high vision-related quality of life. The study utilized the Visual Function Questionnaire-14 from the National Eye Institute and four additional questions, and patients reported that the tested vision-related tasks could be performed with either no difficulty or a little difficulty (Figure 5).

Figure 5. Vision-related task questionnaire scores of 48 patients implanted bilaterally with PanOptix Trifocal IOL as assessed with the National Eye Institute Visual Function Questionnaire-14 in a prospective, single-arm study.13 Patients were asked to score tasks that they perform on a daily basis with either 0 = no difficulty; 1 = little difficulty; 2 = moderate difficulty; 3= quite difficult; or 4 = impossible to perform task.

And finally, in a prospective, single-arm, post-market clinical study including 145 eyes across 17 clinical sites in Europe, Latin America, and Australia, only 2 to 3% of these patients reported unsolicited visual disturbances of halos and glare after PanOptix Trifocal IOL implantation.7

Dr. Braga-Mele: We talked a little bit about visual disturbances, such as halo and glare. When we look at studies, we should differentiate between solicited (surgeon-prompted) and unsolicited (self-reported). Prof. Kohnen, I believe you did a study where you looked at visual disturbances. Can you talk to us with respect to visual disturbances?

Prof. Kohnen: Yes, and you touched on an important point. If you do scientific studies and ask really specific questions of each patient, begin to pay attention to their reaction time. Do they have to put effort into thinking about it? Over time, patients adjust and forget about the phenomena unless we remind them with our questions.

Summary

Dr. Braga-Mele: There are several IOL modalities and approaches available in the United States to help patients see well at various distances. While there is no technology today that will give a patient back their youthful vision, PanOptix Trifocal IOL technology consistently provides good visual acuity at distance, intermediate, and near. As with any diffractive IOL technology, there are optical phenomena, however most patients are not bothered by them and adapt to their presence especially if the appropriate patient is chosen for the lens. PanOptix Trifocal IOL patients are highly satisfied with their vision.6,13 This is a technology that has the potential increase the overall usage of PCIOLs.

Roundtable participants are paid Alcon consultants.

© 2019 Alcon Inc.11/19US-ACP-1900101

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

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

2. Charness N, Dijkstra K, Jastrzembski T, et al. Monitor viewing distance for younger and older workers. Proc Hum Factors Ergon Soc. 2008;3:1614-1617.

3. Positioning the Monitor. ccohs.ca. https://www.ccohs.ca/oshanswers/ergonomics/office/monitor_positioning.html. Accessed August 15, 2019.

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

5. Alcon Data on File.

6. Kohnen T, Herzog M, Hemkeppler E, et al. Visual performance of a quadrifocal (trifocal) intraocular lens following removal of the crystalline lens. Am J Ophthalmol. 2017;184:52-62.

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

8. Scheepers M. Initial results of clinical visual outcomes of a trifocal IOL and an extended depth of focus (EDOF) IOL implantation following bilateral cataract surgery. Presented at: ASCRS. May 2019, San Diego, California.

9. Cochener B, Boutillier G, Lamard M, et al. A comparative evaluation of a new generation of diffractive trifocal and extended depth of focus intraocular lenses. J Refract Surg. 2018;34(8):507-514.

10. Hu JG, Rendon, A, Hu GY, et al. Scotopic near and intermediate vision results with a new advanced technology one piece acrylic trifocal design IOL. Presented at: ASCRS. May 2019, San Diego, California.

11. Monaco G, Gari M, Di Censo F, et al. Visual performance after bilateral implantation of 2 new presbyopia-correcting intraocular lenses: trifocal versus extended range of vision. J Cataract Refract Surg. 2017;43(6):737-747.

12. Ruiz-Mesa R, Abengózar-Vela A, Ruiz-Santos M. A comparative study of visual outcomes between a new trifocal and an extended depth of focus intraocular lens. Eur J Ophthalmol. 2018;28(2):182-187.

13. Böhm M, Hemkeppler E, Herzog M, et al. Comparison of a panfocal and trifocal diffractive intraocular lens after femtosecond laser-assisted lens surgery. J Cataract Refract Surg. 2018;44(12):1454-1462.

14. Akman A, Asena L, Ozturk C, et al. Evaluation of quality of life after implantation of a new trifocal intraocular lens. J Cataract Refract Surg. 2019;45(2):130–134.

author
Rosa Braga-Mele, MD, Med, FRCSC (moderator)
  • Professor of Ophthalmology, Faculty of Medicine, University of Toronto, Canada
  • rbragamele@rogers.com
  • Financial disclosure: Consultant (Alcon, Zeiss); No financial interest in any product
author
Thomas Kohnen, MD, PhD, FEBO
  • Professor and Chair, Department of Ophthalmology, Goethe University,
    Frankfurt, Germany
  • kohnen@em.uni-frankfurt.de
  • Financial disclosure: : Consultant and research (Abbott/J&J, Alcon/Novartis, Avedro, Oculentis, Oculus, Presbia, Schwind, Zeiss); Consultant (Allergan, Bausch & Lomb, Dompé, Geuder, Merck, Rayner, Santen, Staar, Thea, TearLab, Thieme, Ziemer); Research (Hoya)
author
Marius Scheepers, MD
  • Consultant Ophthalmologist, Trail, British Columbia, Canada
  • mascheepers@gmail.com
  • Financial disclosure: Consultant (Alcon)
author
Jerry Hu, MD
  • Texas Eye and Laser Center, Fort Worth, Texas, USA
  • jerryganghu@hotmail.com
  • Financial disclosure: Consultant (Alcon, Allergan, Bausch & Lomb, Ivantis, Shire, Sun)
author
Jeff Horn, MD
  • Vision For Life, Nashville, Tennessee, USA
  • jdh@comcast.net
  • Financial disclosure: Clinical Investigator (Alcon, Bausch + Lomb), Consultant and speaker (Alcon)

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.