Implantation of Refractive Multifocal Intraocular Lens With A Surface-Embedded Near Section For Cataract Eyes Complicated With A Coexisting Ocular Pathology

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Eye (2015) 29, 649–655

© 2015 Macmillan Publishers Limited All rights reserved 0950-222X/15


www.nature.com/eye

Implantation of M Ouchi1,2 and S Kinoshita2

CLINICAL STUDY
refractive multifocal
intraocular lens with
a surface-embedded
near section for
cataract eyes
complicated with
a coexisting ocular
pathology

Abstract
Purpose To evaluate the postoperative Introduction
outcomes of cataract eyes complicated with
At present, two types of multifocal intraocular
coexisting ocular pathologies that underwent
lenses (MIOLs) are available, diffractive MIOLs
implantation of a refractive multifocal
and refractive MIOLs, and careful patient
intraocular lens (MIOL) with a surface-
selection and choice of lens type are key for the
embedded near section.
successful use of MIOLs.1 In refractive MIOLs,
Methods LENTIS MPlus (Oculentis GmbH)
halo or glare symptoms are more prominent
refractive MIOLs were implanted in 15 eyes
than in diffractive MIOLs because of light
with ocular pathologies other than cataract
scattering at the transitional zone between the
(ie, six high-myopia eyes with an axial length
longer than 28 mm, two fundus albipunctatus distant and near focus of the MIOL.2 In addition,
eyes, two branch retinal-vein occlusion eyes, the near visual acuity (VA) when using
four glaucoma eyes (one with high myopia), refractive MIOLs tends to depend on pupil size
and two keratoconus eyes). Uncorrected or because of the near focus zone of the MIOL
corrected distance and near visual acuity (VA) being concentrically allocated.3 On the other
(UDVA, UNVA, CDVA, and CNVA), contrast hand, one underlying problem associated with 1
Ouchi Eye Clinic, Kyoto,
sensitivity, and defocus curve were measured diffractive MIOLs is the reduced contrast post Japan
at 1 day and 6 months postoperatively, implantation due to the optical feature of the
and each patient completed a 6-month lens.4–6 2
Department of
postoperative questionnaire regarding vision The LENTIS MPlus (Oculentis GmbH, Berlin, Ophthalmology, Kyoto
Germany) is an acrylic refractive MIOL that was Prefectural University of
quality and eyeglass use. Medicine, Kyoto, Japan
Results Thirteen eyes (87%) registered 0 or designed on the basis of refractive rotational
better in CDVA and 12 eyes (73%) registered asymmetry. The aim of that design is to reduce Correspondence:
better than 0 in CNVA. Contrast sensitivity in sources of light scattering and aberrations that M Ouchi, Ouchi Eye Clinic,
the eyes of all patients was comparable to that cause disturbing reflections, halos, and glare; 47-1 Karahashi Rajomon-
of normal healthy subjects. No patient required several studies have reported the clinical results cho, Minami-ku, Kyoto
601-8453, Japan
eyeglasses for distance vision, but three patients of that lens design.7–10 Although studies have
Tel: +81 75 662 7117;
(20%) required them for near vision. No patient reported that the postoperative contrast Fax: +81 75 662 7118.
reported poor or very poor vision quality. sensitivity outcomes using other MIOLs are E-mail: mouchi@skyblue.
Conclusion With careful case selection, worse than those with monofocal IOLs,11,12 Alió ocn.ne.jp
sectorial refractive MIOL implantation is et al8 reported that the postoperative contrast
sensitivity outcomes with MPlus are comparable Received: 29 July 2014
effective for treating cataract eyes complicated
Accepted in revised form:
with ocular pathologies. to those of monofocal IOLs. 24 December 2014
Eye (2015) 29, 649–655; doi:10.1038/eye.2015.12; Although the use of diffractive MIOLs has Published online:
published online 6 March 2015 become increasingly popular because of their 6 March 2015
Sectorial refractive multifocal IOL for complicated ocular pathologies
M Ouchi and S Kinoshita
650

good reading-distance VA and their option of variably approved by the ethical committee of Ouchi Eye Clinic,
adding power for near vision, some patients, even those Kyoto, Japan.
with healthy eyes, complain of hazy vision, which might
be the result of reduced contrast. Therefore, it is known
MIOL and calculation
that careful consideration must be taken when deciding
whether to implant MIOLs in elderly patients over 80 The MIOLs used in this study were the LENTIS MPlus
years of age or in patients with corneal or retinal diseases. LS-313MF30 and the LENTIS MPlus Toric LU-313MFT
Ophthalmic surgeons debate on whether or not to (Oculentis). Both MIOLs are biconvex plate haptic acrylic
implant MIOLs in interdisciplinary cases such as patients MIOLs that have an aspheric distance-vision zone
with early-stage glaucoma, high myopia with good combined with sector-shaped near-vision zone of 3.0
corrected VA, or mild keratoconus, because, unlike with diopters (D) addition. Theoretically, this design makes the
monofocal IOL implantation in such subclinical IOL independent of pupil size for near VA. The toric model
handicapped cases, MIOL implantation can result in a is also provided in the same platform. Available D choices
decrease in the patient’s visual function because of the range from 0 to 36.0 D with 0.01 D steps in spherical power,
precision of the lens. However, the use of refractive and from 0.25 D to 12.0 D with 0.01 D steps in cylinder
MIOLs has the potential advantage of avoiding light power. The IOL spherical power was calculated using the
scattering due to diffraction and less light energy loss, and Haigis formula on an optical biometer (IOLMaster;
thus it is feasible that those lenses can be implanted in Carl Zeiss Meditec AG, Jena, Germany). Data for the IOL
such cases. Although there are reported clinical results of calculations were taken from direct use of the optical
MPlus implantation in cases of anisometropic biometry (IOLMaster; Carl Zeiss Meditec AG) or from
amblyopia,13 there has yet to be a report regarding MPlus ultrasonic immersion biometry data in cases with a dense
implantation in eyes afflicted with organic eye disease. cataract. The IOL cylinder power and alignment axis were
The purpose of this study was to evaluate the clinical calculated and provided by the product manufacturer
results of MPlus sectorial refractive MIOL implantation in taking into account the IOLMaster keratometry readings, as
eyes with cataract complicated with a coexisting ocular well as mandatory data input on the incision location and
pathology. an estimate of the surgically induced astigmatism.

Patients and methods Surgical technique

Patients For the cases requiring the toric model, three marks (two
horizontal and one vertical) were made along the limbus
This prospective, consecutive, nonrandomized, prior to surgery using a 24-guage (G) needle with
interventional, clinical case study involved 15 eyes of 11 marker ink (Gentian Violet Marker Pad; Becton,
patients ranging in age from 23 to 72 years (mean age: Dickinson and Co., Franklin Lakes, New Jersey, NY,
51.4 ± 11.84 years (mean ± SD)), with cataract complicated USA) with the patient in a sitting position. At the
with other ocular pathologies possibly affecting visual beginning of surgery, the steepest meridian was marked
function, who underwent cataract surgery with with a toric-IOL corneal gauge and a toric-IOL axis
implantation of a sectorial refractive MIOL. Eyes with an marker (both from Duckworth and Kent Ltd., Baldock,
axial length longer than 28 mm were considered as high- United Kingdom). A 2.2-mm bent clear corneal incision
myopia eyes, and eyes in which choroidal was made using a 2.2-mm disposable steel knife
neovascularization was detected by optical coherence (Slit knife 2.2DB; Alcon Laboratories, Inc., Fort Worth,
tomography (OCT) were excluded from the study. Eyes TX, USA). Phacoemulsification was performed using
showing apical decentration, asymmetric bowtie, and the Infiniti Vision System (Alcon Laboratories) with
indices of keratoconus in corneal topography images an attached 0.9-mm mini flare ABS phaco tip, 45º
were diagnosed as keratoconus. Eyes with both optic disc KELMAN, and ultra-sleeve (Alcon Laboratories).
cupping of cupping/disc ratio 40.6 and glaucomatous After the capsule was filled with the viscoelastic agent, a
visual field defect detected using a perimeter (Octopus LENTIS MPlus or LENTIS MPlus Toric IOL was inserted
900; Haag-Streit AG, Koeniz, Switzerland) were included using a Viscoject-injector affixed with a Viscoglide 2.2
in the glaucoma eyes. Other fundus diseases were cartridge (both from Oculentis). In the toric model, the
diagnosed by funduscopic examination, fluorescein IOL was rotated to adjust its toric mark onto the corneal
angiography, and/or OCT depending on the disease. axis mark that was marked at the start of surgery
Prior informed consent was obtained from all patients, under irrigation with a 22-G irrigating cannula (MST,
and this study was performed in accordance with the Redmond, WA, USA) after removal of the viscoelastic
tenets set forth in the Declaration of Helsinki and was material. Of the 15 eyes, the toric model IOLs were

Eye
Sectorial refractive multifocal IOL for complicated ocular pathologies
M Ouchi and S Kinoshita
651

implanted in 9 eyes of 7 patients, and there were no added in 0.5 D steps from +2.0 to − 6.0 D, and VA was
intraoperative complications. recorded for each type of blur. All recorded information
was represented in a 2-dimensional graphic.
At the final follow-up visit (ie, 6 months postoperatively),
Outcome measures
all patients completed a questionnaire pertaining to the
Preoperatively, all patients underwent a full ophthalmic following: (1) spectacle use for distance and near vision
examination including refractive status, distance VA slit- (response scale: 1 = never, 2 = occasionally, and
lamp evaluation, pupil size of photopic condition, 3 = always) and (2) overall opinion of the quality of
tonometry, fundoscopy, and a visual field test; corneal distance and near vision (response scale: 1 = very poor,
topography and optical coherence tomography (OCT) 2 = poor, 3 = acceptable, 4 = good, and 5 = very good).
were performed according to need in some cases. The
schedule of postoperative examinations was as follows:
uncorrected and corrected distance VA (UDVA and
Results
CDVA, respectively) and uncorrected and corrected near
VA (UNVA and CNVA, respectively) were evaluated at Preoperative baseline data
1 day and 6 months postoperatively, and other
All enrolled patients completed all of the scheduled
evaluations including contrast sensitivity testing,
examinations. The mean preoperative CDVA and BDVA
measurements of VA from intermediate to near, and
were 1.35 ± 0.51 (logMAR) and 0.27 ± 0.47 (logMAR),
defocus curve were performed at 6 months
respectively. Mean preoperative refractive equivalent and
postoperatively. Refractive status and corneal
corneal astigmatism were -9.48 ± 6.64 D and 1.38 ± 0.55 D,
astigmatism were examined using an autorefractor/
respectively. The toric model IOL was implanted into 13
keratometer (ARK-560 A; Nidek Co., Ltd, Gamagori,
Japan). Contrast sensitivity was evaluated with best of the 15 eyes. The mean axial length was 26.5 ± 2.55 mm
distance correction without glare under a mesopic and the mean photopic pupil diameter was 3.82 ± 0.61
condition using a vision testing instrument (CSV-1000; (2.70–4.62) mm. The breakdown of the coexisting diseases
VectorVision, Greenville, OH, USA). In addition to is as follows: high myopia with axial length longer than
UDVA, BDVA, UNVA, and CNVA, near-to-intermediate 28 mm (six eyes of four patients), fundus albipunctatus
distance VA was measured using a multi-distance chart (two eyes of one patient), branch retinal vein occlusion
(TMI-V5; Precision Vision, La Salle, IL, USA) that is set (two eyes of two patients), a past history of acute angle-
with VA sheets for 1 m, and for 70, 50, 40, and 30 cm; closure glaucoma of Aulhorn classification stage 3 (one
uncorrected VA and distance-corrected VA were eye of one patient), normal-tension glaucoma of Aulhorn
measured using these sheets. The defocus curve data were classification stage 1 (three eyes of two patients; one of
obtained at a distance of 5 m with monocular vision and those three eyes was also high myopia), and keratoconus
the patient’s distance correction. Spherical lenses were (two eyes of two patients) (Table 1).

Table 1 Preoperative Patient data

Case Age Sex CDVA CC SE Pupil Size Complication

1 47 M 0.9 0.75 − 20.125 3.84 High Myopia


2 47 M 0.8 1.25 − 21.875 3.82 High Myopia
3 41 F 0.5 2.5 − 0.125 4.62 Keratoconus
4 49 F 0.6 1.5 − 4.375 2.7 BRVO
5 55 M 1.5 1.5 − 8.25 4.06 High Myopia
6 55 M 0.7 1.5 − 13.125 3.36 High Myopia
7 62 F 1.2 0.75 − 3.575 4.19 BRVO
8 72 F 0.7 0.75 − 2.575 3.53 Acute Glaucoma
9 23 M 0.1 1.5 − 6.50 4.22 Keratoconus
10 45 F 0.6 1 − 13.875 4.06 NTG
11 45 F 0.5 1.25 − 14.75 4.29 NTG, High Myoia
12 45 M 0.02 1.5 − 14.5 2.62 High Myopia
13 61 F 0.8 2.25 − 8.75 4.05 Fundus Albipunctatus
14 61 F 0.9 2 − 7.75 4.58 Fundus Albipunctatus
15 63 F 0.9 0.75 − 2.1 3.31 NTG
Abbreviations: BRVO, branch retinal vein occulusion; CDVA, corrected distance visual acuity; CC, cornal cylinder; High Myopia, high myopia with axial
length greater than 28mm; NTG, nomal tension glaucoma; SE, spherical equivalent.

Eye
Sectorial refractive multifocal IOL for complicated ocular pathologies
M Ouchi and S Kinoshita
652

Postoperative outcome The mean monocular defocus curves are shown in


Figure 2a. As shown in the figure, there were two peaks
The mean postoperative manifest spherical equivalent
of maximum vision located at far and near focus, with
was − 0.11 ± 0.54 D (−0.75 to 0.625 D), the mean corneal
reduced VA for intermediate distances. The far peak of
cylinder was 1.54 ± 0.53 D (0.75 to 2.5 D), and the manifest
the monocular curves was − 0.07 ± 0.13 (logMAR), and the
cylinder was 0.36 ± 0.66 D (0 to 1.75 D); the toric model
was implanted in 13 of the 15 eyes. peak of optimum near vision was 0.15 ± 0.19 (logMAR) at
The UDVA, CDVA, UNVA, and CNVA at 1 day and the variance of − 2.5 D which was equivalent of 40 cm
6 months postoperatively are shown in Figure 1. The from the eye.
mean UDVA and CDVA were − 0.016 ± 0.12 and Values of near to intermediate VA are shown in
− 0.08 ± 0.09 logMAR, respectively, at 1 day Figure 2b. Both uncorrected and distance-corrected VA
postoperatively, and all eyes registered better than 0.18 registered the best acuity at 50 cm but registered 0.21
both in UDVA and CDVA. Of the 15 operated eyes, 53% logMAR or better at all distances. Moreover, the mean
registered 0 or better in UDVA, 87% registered 0 or uncorrected VA registered 0.14 logMAR at 30 cm, 0.12
better in CDVA (Figure 1a), and the mean UDVA and logMAR at 40 cm, and 0.10 logMAR at 70 cm. Both
CDVA were -0.001 ± 0.11 and − 0.07 ± 0.11, respectively, uncorrected and distance-corrected VA did not show a
at 6 months postoperatively (Figure 1b). The mean marked decrease in intermediate VA.
UNVA and CNVA were 0.19 ± 0.17 and − 0.03 ± 0.09 Contrast sensitivity registered higher at three and six
logMAR, respectively, at 1 day postoperatively cycles per degree and lower at 18 cycles per degree than
(Figure 1c), and 0.2 ± 0.19 and -0.01 ± 0.12 logMAR, the lower boundary of normal healthy subjects aged 20–
respectively, at 6 months postoperatively; 73% of the 60 years, as provided by VectorVision, the manufacturer
eyes registered better than 0 in CNVA. Only two eyes of the contrast sensitivity test scale (Figure 3), and was
achieved better than 0 in UNVA, and 20% of the eyes comparable to previously reported data of MPlus-
registered worse than 0.3 in UNVA (Figure 1d). implanted healthy eyes.7–10

Figure 1 Corrected and uncorrected distance visual acuity (VA) at 1 day (a) and 6 months (b) postoperative. Corrected and uncorrected
near VA at 1 day (c) and 6 months (d) postoperative (UDVA, uncorrected distance VA; CDVA, corrected distance VA; CNVA, corrected
near VA; UNVA, uncorrected near VA).

Eye
Sectorial refractive multifocal IOL for complicated ocular pathologies
M Ouchi and S Kinoshita
653

Of the 11 patients, all were completely independent of


spectacles for distance vision. For near vision, one
patient needed to use eyeglasses occasionally, and one
patient needed to use eyeglasses constantly. For
distance vision, 11 patients (100%) rated their quality of
vision as 4 or higher (very good or good) among five
items, and seven patients (64%) rated it at 5 (very good).
For near vision, 11 patients (100%) rated their quality of
vision as 3 (acceptable) or higher and three (27%) rated
it at 5 (very good). None of the patients rated their
quality of vision as 1 or 2 (very poor or poor) for both
distance and near vision (Figure 4). Two patients (20%)
reported having ‘hazy vision’; however, neither of those
two patients reported that the haziness caused them any
difficulty.

Discussion

LENTIS MPlus sectorial addition refractive MIOLs were


implanted into 15 eyes with cataract complicated with a
coexisting ocular pathology, and the clinical results were
evaluated. All operated eyes achieved good UDVA with
useful near vision from the early postoperative period. All
distance VA tests revealed good uncorrected VA at any
distance from near to intermediate (30 cm to 1 m). The
findings of this study revealed that the refractive MIOL
Figure 2 Mean monocular defocus curve after Lentis MPlus IOL profile was maintained, even in cataract eyes complicated
implantation (a) Peaks of maximum VA were seen approximately with coexisting ocular diseases.
at the 0.00 and − 2.50 D. Defocus curve indicates same feature as
this intraocular lens, even implanted into complicated eyes. Mean
The registered comparative contrast sensitivity findings
monocular uncorrected and distance-corrected VA at near to in this case series are similar to those previously reported
intermediate distances (b) This direct measurement of near to of diffractive MIOLs implanted into cataract eyes with no
intermediate distance VA also revealed the feature of this coexisting ocular pathology.4 The LENTIS MPlus MIOL is
refractive MIOL as well as defocus curve. Both uncorrected and designed to overcome the drawbacks of other MIOLs by
distance-corrected VA registered the best acuity at 50 cm but
registered 0.21 logMAR or better at all distances (IOL = intrao-
providing high contrast sensitivity and minimizing halo
cular lens, VA = visual acuity). and glare,12 a design that is based on the concept of
refractive rotational asymmetry. Reportedly, the aim of
the technology is to reduce sources of light scattering and
aberrations.8 In fact, both Muñoz et al7 and Alió et al8–10
reported that contrast sensitivity in MPlus-implanted
patients was similar to that in monofocal IOL-implanted
patients at any spatial frequency.7–10 Moreover, Alió
et al9,10 reported that eyes implanted with an MPlus MIOL
registered higher contrast sensitivity than did eyes
implanted with a diffractive MIOL. This feature might
also contribute especially for good distance vision,7 and
the immediate visual rehabilitation shown in our results
at 1 day postoperatively.
The results of our patient questionnaire revealed an
excellent rate of patient satisfaction with regard to
postoperative distance vision, which agrees with the
Figure 3 Mesopic log contrast sensitivity function at far
results of the above-referenced previous reports. In
distance. Contrast sensitivity registered higher at three and six
cycles per degree and lower at 18 cycles per degree than the addition, the rate of spectacle independence was very
lower age boundary of normal healthy subjects from 20 to 60 similar to that of a previous report of MPlus-implanted
years of age. healthy eyes,7 thus indicating that the multifocal

Eye
Sectorial refractive multifocal IOL for complicated ocular pathologies
M Ouchi and S Kinoshita
654

Figure 4 Postoperative spectacle independency and patient satisfaction rate from questionnaire.

mechanism of this MIOL does not decrease the quality of disorder. More objective evidence with a larger number of
vision, even in complicated eyes. cases and pertaining to other ocular complications, as well
Refractive MIOLs were introduced in 1995 in Japan, as long-term evaluation, is required. In addition, careful
followed by diffractive MIOLs such as the Alcon consideration is needed, especially in cases with a
ReSTOR IOL (Alcon, Fort Worth, TX, USA) or the Abbott potential progressive pathology.15
Medical Optics TECNIS Multifocal IOL (Abbott In addition, a more clear designation of the indication
Laboratories Inc. Abbott Park, IL, USA), and a large for refractive MIOL implantation needs to be established
proportion of MIOLs currently used are diffractive for each disease. Moreover, there is an urgent need to
MIOLs for the above-mentioned reasons. However, clarify the indication for MIOL implantation in such cases
surgeons occasionally come across cases that complain of owing to the increasing needs for presbyopia correction.
hazy vision caused by a decrease of contrast In conclusion, use of the LENTIS MPlus sectorial
accompanied with diffraction phenomena,4–6,14 even refractive MIOL for cataract eyes complicated with
though the eye in which the MIOL is implanted is ocular pathologies can achieve good UNVA with no
significant adverse effect. It is possible that, when
otherwise healthy except for cataract.4 With that aside, it
performed with careful case selection, implantation of
is still difficult to predict preoperatively which cases
refractive MIOLs is relatively suitable for patients who
might experience a postoperative outcome of hazy
have eye diseases other than cataract yet wish to have a
vision. Moreover, it is often stated that complicated
life independent of the need to wear glasses. Thus, these
cataract eyes are a contraindication of diffractive MIOL
findings might contribute to an expansion of the number
implantation. However, the exact branching point of
of patients who can benefit from this premium MIOL
indication and contraindication remains unclear. On the technology.
other hand, the relatively high contrast of refractive
MIOLs is well reported,9,10 and this feature should be
considered in the future for indication or selection of
MIOL implantation. de Wit et al13 implanted the LENTIS Summary
MPlus MIOL bilaterally in the eyes of 14 anisometropic What was known before
amblyopic patients. The results of their study showed K Refractive multifocal IOLs (MIOLs) can achieve

improvements in VA, binocular function, reading speed, uncorrected distance and near visual acuity with less
dropoff of intermediate vision, and can contribute to
and quality of life score, with no significant side effects.
independence from spectacles.
Eyes having diseases other than cataract itself present a
K Sectorial refractive MIOLs have less light scattering and
handicap for postoperative VA; thus, preservation of provide high contrast sensitivity.
contrast sensitivity is an important goal in MIOL
implantation in such cases. What this study adds
Comparative controlled clinical trials are virtually K Implantation of sectorial refractive MIOLs in cataract eyes

impossible in such case series, for, as shown in this complicated with coexisting ocular pathologies provides
excellent distance vision and good near vision with
study, the coexisting ocular pathologies included only one
comparative glass-wear independence and no side effects.
corneal disease, glaucoma, and three kinds of retinal

Eye
Sectorial refractive multifocal IOL for complicated ocular pathologies
M Ouchi and S Kinoshita
655

Conflict of interest 8 Alió JL, Piñero DP, Plaza-Puche AB, Chan MJ. Visual
outcomes and optical performance of a monofocal
The authors declare no conflict of interest. intraocular lens and a new-generation multifocal intraocular
lens. J Cataract Refract Surg 2011; 37241–37250.
9 Alió JL, Plaza-Puche AB, Javaloy J, Ayala MJ, Moreno LJ,
Acknowledgements Piñero DP. Comparison of a new refractive multifocal
intraocular lens with an inferior segmental near add and a
We thank John Bush for reviewing the manuscript.
diffractive multifocal intraocular lens. Ophthalmology 2012;
119: 555–563.
10 Alió JL, Plaza-Puche AB, Javaloy J, Ayala MJ. Comparison
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