Delivering Intermediate Vision: The New TECNIS Eyhance Monofocal IOL - The Ophthalmologist

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Delivering Intermediate Vision: The New TECNIS Eyhance Monofocal IOL - The Ophthalmologist
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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.

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Delivering Intermediate Vision: The New TECNIS Eyhance Monofocal IOL - The Ophthalmologist
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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
Delivering Intermediate Vision: The New TECNIS Eyhance Monofocal IOL - The Ophthalmologist
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   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
Delivering Intermediate Vision: The New TECNIS Eyhance Monofocal IOL - The Ophthalmologist
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                                                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.
Delivering Intermediate Vision: The New TECNIS Eyhance Monofocal IOL - The Ophthalmologist
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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

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Delivering Intermediate Vision: The New TECNIS Eyhance Monofocal IOL - The Ophthalmologist
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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
Delivering Intermediate Vision: The New TECNIS Eyhance Monofocal IOL - The Ophthalmologist
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

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