Delivering Intermediate Vision: The New TECNIS Eyhance Monofocal IOL - The Ophthalmologist
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A Sponsored Supplement From Delivering Intermediate Vision: The New TECNIS Eyhance Monofocal IOL Highlights from the Frankfurt January 2019 Advisory Board Meeting Attendees: Valentin Apostolov, the Netherlands Alfonso Arias Puente, Spain Gerd Auffarth, Germany Oliver Findl, Austria Gonzaga Garay Aramburu, Spain Frank Goes Jr., Belgium Oege Goslings, the Netherlands Remi Mascali, France Rita Mencucci, Italy Scipione Rossi, Italy Marco Tavolato, Italy Daniele Tognetto, Italy Bart Zijlmans, the Netherlands This supplement reflects the opinions and experiences of Advisory Board meeting participants, who met in Frankfurt, Germany, on January 11, 2019. www.jnj.com
2 S p o ns o r e d S up p l e m e n t Since the introduction of aspherical IOLs in 2001 (1) improvements in the optical performance of monofocals IOLs have been minor. However, this could be set to change with the introduction of the TECNIS Eyhance IOL, model ICB00, from Johnson & Johnson Vision. In January of this year, 13 leading ophthalmic surgeons from Germany, Austria, France, Italy, Spain, the Netherlands and Belgium met in Frankfur t to compare their experience with this novel IOL. These surgeons were first introduced to the TECNIS Eyhance IOL in September 2018, during the ESCRS Congress in Vienna. Subsequently, they evaluated the lens in their own practices, as part of a limited introduction. Figure 1. Power maps of the TECNIS® Monofocal (ZCB00) and TECNIS Eyhance (ICB00) IOLs. What were the results of this real- world evaluation? In brief, the surgeons’ TECNIS® IOLs. Nevertheless, the new other approved aspheric monofocal experiences reflected the TECNIS lens is distinguished by a critical difference IOLs (2). Furthermore, in large pupil Eyhance IOL clinical trial results (Part II). in design – namely, a continuous change in eyes the TECNIS Eyhance IOL provides Specifically, the new TECNIS Eyhance IOL power from the periphery to the center significantly better contrast than other provided comparable distance vision to of the lens, creating a unique anterior monofocal IOLs. the TECNIS® monofocal IOL ZCB00 and surface that improves intermediate gave the patients enhanced intermediate vision, maintains distance image quality Part II. The clinical trial vision outcomes. Patients fed back comparable to aspheric monofocal IOLs, that they were able to enjoy activities delivers a profile of photic phenomena The prospective, multi-center, randomized dependent on intermediate vision – such similar to ZCB00 and keeps on reducing clinical study compared the clinical as handicraft or woodwork – and walk spherical aberration to near zero. performance of the TECNIS Eyhance more confidently on uneven surfaces. Note that the TECNIS Eyhance IOL, IOL with that of the TECNIS® Monofocal Furthermore, photic phenomena reports unlike other monofocal lenses, is not IOL ZCB00 (3). Both the evaluator and after TECNIS Eyhance IOL implantation based on a spherical-aberration (SA) the subject were masked. The primary were similar to those typically associated based or zonal design, but the continuous endpoint for the study was distance- with monofocal lenses. These results – power profile is created with a higher corrected intermediate visual acuity like those of the clinical trial (Part II) – are order asphere. A comparison of power (DCIVA); secondary endpoints were best due to the unique technology built into maps spotlights the unique structure of corrected distance visual acuity (BCDVA) the TECNIS Eyhance IOL. the new lens (Figure 1) and emphasizes and uncorrected intermediate visual acuity that ~85 percent of the surface of the (UCIVA). From a total of 68 subjects Part I: The technology TECNIS Eyhance IOL and TECNIS ® bilaterally implanted with the TECNIS Monofocal lenses have exactly the same Eyhance IOL, and 72 controls bilaterally With the naked eye the TECNIS features; the difference between them implanted with TECNIS ® Monofocal, Eyhance refractive IOL (ICB00) is lies only in the central area. 67 and 72 individuals respectively were indistinguishable from the TECNIS ® The consequence of this novel design followed up at six months. Monofocal lens ZCB00 and refers to is a very favorable contrast profile: The results were striking – a monofocal the same base geometry as all other data indicate an equivalent contrast to IOL has been shown in a clinical trial
S p o ns o r e d S up p l e m e n t 3 Furthermore, the TECNIS Eyhance IOL has been shown to provide a similar daytime contrast performance to other IOLs, but superior night-time contrast. In large pupils, image contrast is 31 percent better than with the Clareon® IOL, and 45 percent better than HOYA VivinexTM (2). Figure 2. Modulation transfer function (distance vision): 3 and 5 mm pupils. to deliver significant improvements to not inferior, to the TECNIS® Monofocal intermediate vision. Eyes implanted with IOL in terms of binocular distance vision. the TECNIS Eyhance IOL had significantly In addition, reported rates of photic “Eyes implanted better monocular intermediate vision at phenomena (halo, glare, starbursts) 66 cm than the controls (mean TECNIS were similar for both lenses. Regarding with the Eyhance IOL DCIVA value was 1.1 lines defocus, measurements indicate that the logMAR better than the mean DCIVA TECNIS Eyhance IOL has a larger ‘landing TECNIS Eyhance for TECNIS® Monofocal: p
4 S p o ns o r e d S up p l e m e n t Accordingly, eighteen surgeons – all of Daily activities whom routinely implant large numbers of “The age of 75-80 TECNIS® Monofocal IOLs – were asked enjoyed without to evaluate the TECNIS Eyhance IOL years old is the age glasses and, in total, performed 381 TECNIS Eyhance IOL implantations from October of intermediate Patients implanted with the new 2018 to early January 2019, including 149 TECNIS Eyhance monofocal IOL bilateral procedures. vision: playing as part of a limited launch reported And the results were highly encouraging. being able to enjoy the following All surgeons reported bilateral distance cards, using the activities (without glasses): vision to be good or very good, the A-constant working well, and it seemed computer. For this • Driving, including night- numerous patients getting 20/20 distance driving vision due to the broader landing zone of reason, I believe • Reading price tags when the IOL. In addition, surgeons reported shopping on a broad variety of daily activities their this lens will work • Watching TV, including patients told them they could execute reading subtitles comfortably without glasses (see sidebar). very well.” – • Cooking and eating To share the details of the limited launch, • Playing cards thirteen of the eighteen participating Marco Tavolato • Reading at a computer/ surgeons gathered at the Advisory Board tablet/smartphone distance Meeting in Frankfurt. This was an excellent • Playing piano and other opportunity to present and discuss their choose the new TECNIS Eyhance IOL. instruments real-world experiences with the TECNIS Gonzaga Garay Aramburu asserted that his • Feeling more confident while Eyhance IOL, and to share their insights TECNIS Eyhance IOL recipients reported walking, particularly when into this new IOL. Key points to emerge an improvement in their quality of life; in going downstairs or walking from this meeting mainly focused on fact, a patient who had - for reasons of on uneven surfaces confirming the excellent distance vision limited diopter availability during this phase and confirming two additional benefits of early launch – received the TECNIS this lens delivered over traditional Eyhance IOL in one eye and a monofocal monofocal IOLs – improved intermediate TECNIS® ZCB00 in the other could clearly vision and a broader landing zone. see the difference in intermediate vision There was a series of comments on with the TECNIS Eyhance IOL. This patient Part III. The real world: results the benefits of improved intermediate exclaimed that she had “won the lottery” from a limited launch of the vision with Alfonso Arias Puente who with the new IOL. TECNIS Eyhance IOL had expected intermediate vision to An anecdotal comment from another improve considerably in younger adult surgeon was referring to a couple where The clinical trial outcomes were patients but in fact found the greatest both of them had received cataract immensely encouraging – but trials benefit in a 70-year-old patient. Thus, he surgery quite recently: while the male had take place under precisely controlled commented the quality of intermediate received a standard monofocal IOL, his wife conditions. How would the TECNIS vision may not be related that much to experienced better intermediate vision Eyhance IOL perform in the real world? the age of the patient. This finding was for daily activities after having received the Johnson & Johnson Vision collaborated shared by Marco Tavolato who thinks TECNIS Eyhance IOL. with ophthalmic surgeons, with the “the age of 75-80 years is the age of Bart Zijlmans confirmed the impressions aim of collecting accounts of real-world intermediate vision: playing cards, using of previous speakers regarding reports of patient experiences and to learn whether the computer. For this reason, I believe improved visual acuity outcomes with the the TECNIS Eyhance IOL may become a this lens will work very well.” Actually, TECNIS Eyhance IOL and gave the example candidate to change the standard of care he added that if he was choosing an IOL of patients who were able to use in-car in monofocal IOL implantation. for his mother – who is 75 – he would navigation or music systems without glasses.
S p o ns o r e d S up p l e m e n t 5 Figure 3. TECNIS Eyhance IOL provides statistically significant improvement in binocular intermediate vision at 66 cm (3). He commented on patients “gaining” IOL, and good UCIVA. She agreed with impaired night-driving ability, incl. Remi intermediate visual acuity, and asserted Valentin Apostolov’s suggestion that the Mascali, who found his patients being that, for that reason, he would like to see TECNIS Eyhance IOL could replace her highly satisfied with the procedure and his current Monofocal IOL replaced with current Monofocal. Like Marco Tavolato, outcomes, and none of his patients the new TECNIS Eyhance IOL. she suggested that surgeons in busy reporting on photic phenomena. He is In general, there was consent among hospital settings, with large volumes of very keen to use the TECNIS Eyhance many attendees on this view including patients, might find it more convenient to IOL in adult patients under 70 years old, Gerd Auffar th who repor ted little have a single IOL option rather than being in whom he expects the lens to achieve observable difference between TECNIS® obliged to choose between the multiple better outcomes. Monofocal and the TECNIS Eyhance Monofocal IOLs. Oliver Findl was very positive about IOL: patients were positive about the Valentin Apostolov reported that he the unaided distance acuity associated performance of the TECNIS Eyhance IOL was happy to see that TECNIS Eyhance with the TECNIS Eyhance IOL, thanks in terms of distance vision, intermediate IOL recipients have not complained to the broader landing zone, and he vision, and the tasks they were able to about photic phenomena or impaired was encouraged by patient-repor ted perform following implantation. As he night-driving ability, and he was confident intermediate vision acuity in the four saw no advantage to using his current that he would offer the new lens to his weeks after surgery. Likewise, Frank Goes Monofocal rather than the TECNIS patients, most likely as a replacement for believes that he achieved uncorrected Eyhance IOL, he suggests replacing the the monofocal lens he currently uses. 20/20 vision more easily and more rapidly former with the latter. Other clinicians present agreed that with the TECNIS Eyhance IOL than with Rita Mencucci also agreed on very good TECNIS Eyhance IOL recipients have not TECNIS® Monofocal. He added that UCDVA results with the TECNIS Eyhance complained about photic phenomena or he would willingly replace his current www.jnj.com
6 S p o ns o r e d S up p l e m e n t Figure 4. TECNIS Eyhance IOL delivers a bigger landing zone than the TECNIS® 1-piece IOL (3). Monofocal with the TECNIS Eyhance individuals gained the ability to read IOL in his clinic. Intermediate vision from computer screens or tablets “I would be happy activities reported by his patients since unaided. He added that he would be implantation included golf and cooking. happy to replace his current Monofocal to replace the Daniele Tognetto observed that 40 with the TECNIS Eyhance IOL. He also percent of his patients implanted with stated that insurance companies in the currently used the TECNIS Eyhance IOL had better Netherlands require information on the visual acuity (both intermediate and percentage of patients reaching one Monofocal with distance monocular VA) than those who diopter of the target and noted that he had received the TECNIS® Monofocal; as could be certain of achieving his target the TECNIS he saw no disadvantages for the TECNIS with the TECNIS Eyhance IOL – a point Eyhance IOL he would be happy to see it that Zijlmans agreed with. Eyhance IOL.” replace the TECNIS® Monofocal. Finally, Oege Goslings reported that Discussion – Oege Goslings the experiences of his patients had Findl asserted that intermediate vision been exclusively positive: for example, has become increasingly important in
S p o ns o r e d S up p l e m e n t 7 are becoming increasingly well-educated patient and may demand for additional regarding IOL categories and have chair-time. “The advantage certain expectations regarding premium lenses – which is why it is so important In summary of this lens over to correctly categorize a given IOL. The new TECNIS Eyhance monofocal Accordingly, surgeons did not see a need IOL (ICB00) redefines the concept of other lenses to change their patient education for the the monofocal lens. Data from clinical TECNIS Eyhance IOL from their routine trials and real-world patient experience available on the for monofocal lenses and by doing so, suggest that it will become the monofocal there would be a reasonable chance IOL of choice for many ophthalmic market is that a to overdeliver with this new lens – an surgeons. This view is supported by views occurrence that is always appreciated by expressed at the January 2019 Advisory higher number both surgeons and patients. Board Meeting in Frankfurt; surgeons who In addition to improved intermediate participated in this event suggest that the of patients vision many surgeons appreciated that TECNIS Eyhance IOL represents the next the TECNIS Eyhance IOL would be more chapter in IOL innovation, comparable will achieve forgiving. Due to the broader plateau in importance to the evolution from in the defocus curve there would be a spherical to aspherical lenses. uncorrected higher chance to provide 20/20 distance visual acuity to patients even in cases References 20/20 vision.” where the target of emmetropia was 1. K Petermeier et al., “Influence of the pupil size not achieved. Taking into account that on visual acuity after implantation of the – Frank Goes according to large recent trials (4) more Tecnis 1-piece intraocular lens”, Br J than 25 percent of all cataract patients Ophthalmol, 95, 42-45 (2011). PMID: were affected by a prediction error of 20576769. more than +/- 0,5 D, and 7 percent of 2. Data on File, Johnson & Johnson Surgical Vision, the last two decades, mostly due to patients by at least +/- 1.0 D, the broader Inc. 2018. DOF2018OTH4004. For Healthcare the use of smar tphones, tablets, and landing zone of the TECNIS Eyhance IOL Professionals only. patients being able to devote more may be helpful to expand the number 3. Data on File, Johnson & Johnson Surgical Vision, time to activities and hobbies requiring of patients who receive better distance Inc. 2018. DOF2018CT4015. For Healthcare intermediate vision. In this context, he visual acuity. However, this would be at Professionals only. suggested that the TECNIS Eyhance IOL the expense of improved intermediate 4. M Lundström et al., “Risk factors for refractive could be described as a truly “modern” vision that they otherwise may benefit error after cataract surgery: Analysis of monofocal lens, or according to Auffarth from when emmetropia has been reached. 282 811 cataract extractions reported to the a “super-monofocal IOL” that is an Finally, Scipione Rossi initiated a debate European Registry of Quality Outcomes for update to a very established lens. on the idea of low-diopter monovision cataract and refractive surgery”, J Cataract Surgeons agreed that the quality of (within 0.5-0.75D), thanks to the larger Refract Surg. 44(4), 447-452 (2018). PMID: IOLs is constantly improving, and the landing zone, in order to gain additional 29685779. new TECNIS Eyhance IOL provides a visual acuity in intermediate or even higher standard for the field of monofocal near. However, while there is some lenses, reflecting constant evolution of debate among surgeons on the concept design and production technology. of monovision in general, the approach Apostolov stressed that ophthalmic will not likely seem favorable with the surgeons should always under-promise TECNIS Eyhance IOL as patients may see and over-deliver, and therefore should significant compromise on their distance make it clear that the TECNIS Eyhance visual acuity which is known to be the IOL is an improved monofocal lens rather most important outcome parameter. than promising intermediate vision to Moreover, monovision may cause photic patients. Surgeons agreed that patients phenomena, is not tolerated by every www.jnj.com
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