Jurnal Reading

PERBANDINGAN LENSA INTRAOKULAR MULTIFOKAL REFRAKTIF BARU

SEGMENTAL INFERIOR DENGAN PENAMBAHAN JARAK DEKAT DAN
LENSA INTRAOKULAR MULTIFOKAL DIFRAKTIF

Yulita Hera (11.2018.058)

Pembimbing:
dr. Santi Anugrah Sari, Sp.M, M.Sc

Kepaniteraan Klinik Ilmu Penyakit Mata

Fakultas Kedokteran Universitas Kristen Krida Wacana
Periode 11 November 2019 – 14 Desember 2019
Rumah Sakit Umum Daerah Koja, Jakarta
Comparison of a New Refractive Multifocal
Intraocular Lens with an Inferior
Segmental Near Add and a Diffractive
Multifocal Intraocular Lens
1,2 1 1,2
Jorge L. Alio, MD, PhD, Ana B. Plaza-Puche, MSc, Jaime Javaloy, MD, PhD,
1 1,2 3
María José Ayala, MD, PhD, Luis J. Moreno, MSc, David P. Piñero, PhD
Purpose: To compare the visual acuity outcomes and ocular optical performance of eyes implanted with a
multifocal refractive intraocular lens (IOL) with an inferior segmental near add or a diffractive multifocal IOL.
Design: Prospective, comparative, nonrandomized, consecutive case series.
Participants: Eighty-three consecutive eyes of 45 patients (age range, 36 – 82 years) with cataract were
divided into 2 groups: group A, 45 eyes implanted with Lentis Mplus LS-312 (Oculentis GmbH, Berlin, Germany);
group B, 38 eyes implanted with diffractive IOL Acri.Lisa 366D (Zeiss, Oberkochen, Germany).
Methods: All patients underwent phacoemulsification followed by IOL implantation in the capsular bag.
Distance corrected, intermediate, and near with the distance correction visual acuity outcomes and contrast
sensitivity, intraocular aberrations, and defocus curve were evaluated postoperatively during a 3-month follow-
up.
Main Outcome Measures: Uncorrected distance visual acuity (UDVA), corrected distance visual acuity
(CDVA), uncorrected near visual acuity (UNVA), corrected distance near and intermediate visual acuity
(CDNVA), contrast sensitivity, intraocular aberrations, and defocus curve.
Results: A significant improvement in UDVA, CDVA, and UNVA was observed in both groups after surgery
(P#0.04). Significantly better values of UNVA (P 0.01) and CDNVA (P 0.04) were found in group B. In the
defocus curve, significantly better visual acuities were present in eyes in group A for intermediate vision levels of
defocus (P#0.04). Significantly higher amounts of postoperative intraocular primary coma and spherical aber-
rations were found in group A (P 0.01). In addition, significantly better values were observed in photopic contrast
sensitivity for high spatial frequencies in group A (P#0.04).
Conclusions: The Lentis Mplus LS-312 and Acri.Lisa 366D IOLs are able to successfully restore visual
function after cataract surgery. The Lentis Mplus LS-312 provided better intermediate vision and contrast
sensitivity outcomes than the Acri.Lisa 366D. However, the Acri.Lisa design provided better distance and near
visual outcomes and intraocular optical performance parameters.
Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed
in this article. Ophthalmology 2016;119:555–563 © 2016 by the American Academy of Ophthalmology.

The visual rehabilitation of patients after cataract surgery de-
pends, in part, on the type of intraocular lens (IOL) implanted.
In many cases, this includes spectacle dependence for far and
near distances. As a result, recent IOL technology has empha-
sized improved refractive outcomes and distance and near
1–3
spectacle independence. Multifocal IOLs were developed
to provide complete visual function restoration at near and dis-
tance vision. Differences in visual performance achieved with
multifocal IOLs depend on the optical principle and IOL
designs. At present, several multifocal IOL styles are
available. Several studies have confirmed the efficacy of
4 –11
rotationally symmetric multifocal IOLs (diffractive, re-
fractive, or a combination of diffraction and refraction).
However, optical side effects, such as contrast sensitivity,
glare disability, or the presence of halos, have also been reported
10,12–16
frequently with these lenses. To reduce such
side effects, a new concept of multifocality nonsymmetric
11
rotational inferior segmental near add has been recently
developed and introduced into clinical practice.
4,11,17– 24
Many studies have compared visual outcomes
between monofocal and multifocal IOLs or between differ-ent
types of multifocal IOLs with rotational symmetric designs.
However, no studies have compared the visual outcomes and
the intraocular optical performance among the rotationally
symmetric multifocal IOLs and the refrac-tive inferior
segmental near add multifocal IOLs. The in-traocular optical
performance is the study of the intraocular image quality
provided by the intraocular structures of the eye. Contrast
sensitivity, modulation transfer function (MTF), Strehl ratio,
and the analysis of the optical aberra-tions are all optical
quality parameters used to study the
25
optical performance of any type of lens.

© 2016 by the American Academy of Ophthalmology ISSN 0161-6420/12/$–see front matter 555
Published by Elsevier Inc. doi:10.1016/j.ophtha.2015.08.036
 Ophthalmology Volume 119, Number 3, March 2016
The aim of the current study is to compare the visual
acuity outcomes and the ocular and intraocular optical qual-
ity in eyes with a new generation of refractive inferior
segmental near add multifocal IOL in eyes with a full
diffractive symmetric multifocal IOL. The optical perfor-
mance and visual clinical outcomes were analyzed to ascer-
tain which IOL provided the best level of near and inter-
mediate vision and the best optical quality parameters.
Materials and Methods
Patients
This prospective, consecutive, nonrandomized, interventional,
comparative clinical study included 83 eyes of 45 patients (9
unilateral and 36 bilateral cases) with ages ranging from 36 to 82
years. All patients underwent bilateral phacoemulsification fol-
lowed by IOL implantation in the capsular bag. All patients were
adequately informed and signed a consent form. The study
adhered to the Tenets of the Declaration of Helsinki and was
approved by the local ethical committee. The inclusion criteria
used in this study included patients with incipient or moderate
cataract (Lens Opacity Classification System III; NO1, C1, P1, or
more severity) referring a significant reduction of the visual
quality and no other ocular comorbidity that might influence the
visual outcome. The exclusion criteria were patients with active
ocular diseases and topographic astigmatisms 3 diopters (D) or
significant amounts of corneal aberrations observed, using the
Zernike polynomials, from the topography map. All patients were
informed that far vision spectacle independence and astigmatism
correction were not primary goals of this investigation.
Intraocular Lenses
11
The Lentis Mplus LS-312 is an inferior segmental near add
multifocal IOL containing an aspheric distance-vision zone com-
bined with a 3.00 D posterior sector-shaped near-vision zone,
allowing seamless transition between the zones. Theoretically,
light hitting the transition area of the embedded sector is reflected
away from the optical axis to prevent superposition of interference
or diffraction. It has a biconvex design with a 6.0-mm optic size
and an overall length of 12.0 mm. It is made of an acrylic
material, the HydroSmart copolymer (Oculentis GmbH, Berlin,
Germany), which consists of acrylates and a hydrophobic surface
with ultra-violet-absorbing components. Another important
feature of the Lentis Mplus is its 360-degree continuous square
optic and haptic edge.
4
The Acri.Lisa 366D is an aspheric bifocal biconvex
refractive– diffractive IOL. This lens is a single-piece IOL with an
optic diameter of 6.0 mm and an overall diameter of 11.0 mm.
The surface is divided into main zones and phase zones. The
phase zones assume the function of the steps of diffractive IOLs
and have a mean refractive power corresponding to the zero
diffractive power of the main zones. The IOL power responsible
for distance vision is then refractive and diffractive at the same
time. The first diffractive power used for near vision is formed by
an in-phase interference of waves from the main zones. The
incident light is distributed with 65% for a distance focus and
4
35% for near focus. The near add at the lens plane is 3.75 D.
Surgical Technique
All surgeries were performed by 1 of 2 surgeons (J.L.A., J.J.)
using a standard technique of sutureless microincision (micro-
556
incision cataract surgery [MICS]) phacoemulsification. Topical
anesthesia with 2% preservative-free lidocaine (B. Braun, Bar-
celona, Spain) was used in all cases, with mild sedation with
midazolam (Roche, Madrid, Spain). Adequate dilation was ob-
tained with intracameral mydriasis using 1 ml of a vial con-taining
cyclopentolate 1%, phenylephrine 10%, lignocaine 2%, and
balanced saline solution (10 ml). The incision was placed on the
steepest corneal meridian studied by the corneal topog-raphy. The
Acri.Lisa 366D IOLs were implanted using the MICS Acri.Glide
(Zeiss, Oberkochen, Germany) hydraulic in-jector, whereas the
Lentis Mplus LS-312 IOLs were implanted using a specific
injector (Viscoject 2.2 Cartridge-Set LP604240M; Oculentis
GmbH). A corneal incision size of 2.6 mm was performed to
implant the Lentis Mplus LS-312.
The Lentis Mplus LS-312 has horizontal markings to align the
lens so that the bifocal segment is placed inferiorly. Preopera-
tively, no horizontal axis marking in the sitting position was made
to eliminate the effects of cyclotorsion. The IOL horizontal marks
were placed approximately at the horizontal axis of the eye: The
current authors have previously reported the surgical details re-
11,26
lated to the implantation of this particular IOL type. (Alio J,
Fimia A, Moreno L, et al. A brand new multifocal IOL
technology: Benjamin Franklin’s idea from past to present.
[ASCRS 2010 Film Festival Runner-up Instruments &
Device/IOLs]. Boston 2010. ASCRS/ASOA, April 2010.)
The study design was decided as consecutive. Once the patients
were selected, according to the inclusion criteria already described,
eyes were implanted first with the AcriLisa and then with the MPlus
IOL. Patients received monocular or binocular implants but always
with the same IOL model. The monocular outcomes were always
evaluated for the purpose of this investigation. Postopera-tive topical
therapy included a combination of topical antibiotics (ofloxacin 0.3%
[Exocin, Allergan, Inc., Irvine, CA]) and a steroid (dexamethasone
0.1% [Maxidex, Alcon, Irvine, CA]).
Preoperative and Postoperative Examinations
All patients had a full ophthalmologic examination preoperatively,
including the evaluation of the refractive status, distance and near
visual acuities, slit-lamp examination, tonometry, and funduscopy.
The distance visual acuity was measured using Snellen charts, and the
near visual acuity was measured with Radner Reading Charts
27
(Spanish validated version). Apart from these clinical tests, other
specific examinations were also performed: corneal topography
(Costruzione Strumenti Oftalmici, Florence, Italy), ocular aber-
rometry (COAS, Wavefront Sciences, Inc., Albuquerque, NM),
biometry (IOL Master, Zeiss), and contrast sensitivity (CST 1800,
Vision Science Research, Walnut Creek, CA) under photopic (85
2
cd/m ) and low mesopic conditions (3 cd/m ).
2
Patients were evaluated postoperatively during the follow-up
at 1 day, 1 month, and 3 months after surgery. An independent
observer (A.B.P-P.) performed all the examinations following the
standard operative procedures defined in our institution (Vissum
Corpora-tion) for the purpose of the optometric investigations
included in the study. The postoperative examination protocol at 1
and 3 months was identical to the preoperative protocol, with the
addi-tional measurement of the ocular optical performance with
the Optical Quality Analysis System (OQAS; Visiometrics SL,
Ter-rassa, Spain) and the calculation of the intraocular optical
aberra-tions and Strehl ratio. The OQAS is an instrument based on
a double-pass technique developed to perform an objective optical
evaluation of the visual quality. The double-pass technique is
based on recording images of a point source after reflection on the
retina and a double pass through the ocular media. These data are
processed using the device’s software so that the ocular point
spread function (PSF) and the MTF can be obtained. All measure-
 Alio et al Inferior Segmental Near Add vs Diffractive Multifocal IOLs
ments were taken with a 5-mm pupil using phenylephrine 10% for
dilation. The MTF cutoff point was analyzed and recorded. This
cutoff represented the point where the spatial frequency was max-
imal and had a theoretic relationship with the visual acuity (sup-
posing a good macular and neuroprocessing function). In addition,
the Strehl ratio was also analyzed, which is the ratio of peak focal
intensities in the aberrated and ideal PSFs. All these
measurements were performed simulating distance visual
conditions (distance object).
The intraocular optical quality was estimated by calculating
the intraocular optical aberrations from the total eye and the
anterior corneal aberration. 22 As discussed previously, the
Costruzione Strumenti Oftalmici topography system was used to
evaluate the anterior corneal surface, including wavefront
aberrations, and the total ocular aberrations were measured with
the COAS system (Wavefront Sciences, Inc.). The calculation of
the intraocular aberrations was obtained using Visual Optics Lab
software version 6.89 (Sarver and Associates, Inc., Celebration,
FL) by subtracting corneal aberrations to total ocular aberrations 3
months after surgery. When making the subtraction, both maps
were referred to the pupil center, and therefore the measurement
axis should be the same because the illumination conditions were
the same for the places in which both devices (topographer and
aberrometer) were located. The software allowed us to introduce
the off-set between maps in those cases in which pupil diameters
of both measure-ments were different with the aim of introducing
a realignment algorithm in the calculations of the difference.
The aberration coefficients and root mean square (RMS)
values were obtained and analyzed for 5-mm pupil diameters in
all cases. The following parameters were analyzed and recorded:
total RMS, higher-order RMS (computed for Zernike terms
corresponding to third order or higher), low-order RMS
(computed for terms of first and second orders), tilt RMS
1 acuity (UDVA), corrected distance visual acuity (CVDA), and
(computed for the Zernike terms Z1 ), primary coma RMS
1
(computed for the Zernike terms Z 3 ), coma-like RMS (computed
for Zernike terms of the third, fifth, and seventh orders), and
spherical-like RMS (computed for Zernike terms of the fourth and
sixth orders). The corresponding Zernike coefficient for the
0 Tables 2 and 3 summarize the visual and refractive outcomes at 1
primary spherical aberration (Z4 ) was also reported with its sign.
In addition, the PSF was obtained from the intraocular aberrations
by Fourier analysis. This parameter was obtained from the PSF by
performing the quotient between the maximum intensities of light
energy of retinal image in the ana-lyzed eye and in a diffraction-
limited eye. This parameter should be as close as possible to the
value of 1 (perfect optical system) and is related to the ability of
the eye to produce a point image on the retina when a point object
is observed. It should be considered that all these calculations
were performed considering distance visual conditions.
In addition, the defocus curves were obtained postoperatively to
characterize the near visual function. The Radner charts were used for
such purpose at a distance of 40 cm. The defocus curve was obtained
in monocular vision and with the best near correction of the patients.
Plus lenses were added in 0.50 D steps, and the visual acuity was
recorded for each type of blur. Afterward, the same procedure was
repeated using negative lenses. In the defocus curve, 0 D of defocus
corresponds to corrected near visual acuity (CNVA). So, if plus lenses
are added, the test image is further away from the patient. Therefore,
the intermediate vision corre-sponds with a 1.5 D and 1 D of defocus.
The DCVA corre-sponds with a 2.5 D of defocus. All the recorded
Statistical Analysis
The statistical analysis was performed using only monocular data
and the SPSS statistics software package version 15.0 for Win-
dows (SPSS Inc., Chicago, IL). The normality of all data samples
was evaluated using the Kolmogorov–Smirnov test. When para-
metric analysis was possible, the Student t test for paired data was
performed for all parameter comparisons between preoperative
and postoperative examinations. The Student t test for unpaired
data was used to compare the groups. When the parametric anal-
ysis was not possible, the Wilcoxon rank-sum test was applied to
assess the significance of differences between preoperative and
postoperative data, whereas the Mann–Whitney test was used to
compare the analyzed parameters between groups. For all statisti-
cal tests, the same level of significance was used (P 0.05).
Results
Two groups of eyes were consecutively differentiated according
to the IOL implanted: Group A included 45 eyes implanted with
the Lentis Mplus LS-312 (Oculentis GmbH), and group B
included 38 eyes implanted with the diffractive IOL Acri.Lisa
366D (Zeiss). Table 1 summarizes the preoperative conditions of
the groups of eyes analyzed in the study. As shown, no
statistically significant differences were found between age
groups (P 0.22) (Table 1). Axial length, IOL power, mean
keratometry, and manifest cylinder were not significantly different
in these groups (P$0.25). In ad-dition, no significant differences
were found preoperatively be-tween groups for uncorrected near
visual acuity (UNVA), CNVA, and near addition (P$0.38).
Differences between groups for un-corrected distance visual
sphere were statistically significant (P#0.04) (Table 1).
Visual and Refractive Outcomes
and 3 months after surgery, respectively. A significant improve-
ment with surgery in UDVA, CDVA, and UNVA was observed in
both groups (Wilcoxon test; P#0.04). No significant changes were
found postoperatively in the CNVA for both groups (Wilcoxon
test; P$0.27).
At 1 month after surgery, we found statistically significant
differences between groups for CDVA (Mann–Whitney test, P
0.02), with the best visual outcome for patients in group B (Table
2).
For subjective refraction, no significant changes in manifest
cylinder were found during the whole follow-up in both groups
(Wilcoxon test; P$0.34). In contrast, a significant reduction in
manifest sphere was found only in group B (Wilcoxon test;
P#0.01). No significant differences between groups were found
after surgery in manifest sphere (Mann–Whitney test, P$0.07)
(Tables 2 and 3). No statistically significant differences were
observed in manifest cylinder between groups at 1 month and 3
months after surgery (Mann–Whitney test, P$0.07). Near addition
was reduced significantly after surgery in both groups (Wilcoxon
test; P#0.01). Statistically significant differences between groups
in the magnitude of this parameter were found at 1 and 3 months
information was then represented in a 2-dimensional graphic display
using Carte-sian coordinates (x-axis, spherical blur; y-axis, near visual after surgery (Mann–Whitney test, P#0.01) (Tables 2 and 3).
acuity).
Binocular data, subjective symptoms, and quality of life eval- Defocus Curve
uations were excluded for the purpose of this report to limit the
analysis only to monocular data independent from the neuroadap- Figure 1 shows the mean defocus curve for the 2 groups of patients
tation process that follows multifocal IOL implantation. analyzed in the current study. The statistical analysis of the results

557
 Ophthalmology Volume 119, Number 3, March 2016

Table 1. Preoperative Conditions of the 2 Groups of Eyes

Group A (Lentis Mplus, Oculentis Group B (Acri.Lisa 366, Zeiss,

Mean (SD) Range GmbH, Berlin, Germany) Oberkochen, Germany) P Value (Statistical Test)
Age (yrs) 60.12(12.09) 36 to 82 60.74 (8.29)50 to 78 0.22(Student t)
logMAR UDVA 0.74(0.43) 0.00 to 2.00 0.52 (0.33)0.02 to 1.00 0.04(Mann–Whitney)
Sphere (D) 0.89(2.33) 5.00 to 5.50 1.93 (1.96)5.50 to 4.50 0.03(Mann–Whitney)
Cylinder (D) 0.64(0.66) 3.00 to 0.00 0.57 (0.51)2.00 to 0.00 0.88(Mann–Whitney)
logMAR CDVA 0.14(0.25) 0.00 to 1.30 0.03 (0.07)0.00 to 0.40 0.01(Mann–Whitney)
logMAR UNVA 0.85(0.35) 0.00 to 1.22 0.81 (0.32)0.30 to 1.40 0.39(Mann–Whitney)
logMAR CNVA 0.14(0.16) 0.00 to 0.70 0.17 (0.32)0.10 to 1.30 0.38(Mann–Whitney)
Addition 2.23(0.81) 0.00 to 3.00 2.33 (0.37)1.50 to 2.75 0.57(Mann–Whitney)
Km (D) 43.29(1.52) 39.63 to 45.97 43.00 (0.79)41.08 to 44.39 0.25(Mann–Whitney)
Axial length(mm) 23.24(1.11) 21.59 to 26.94 23.32 (0.90)21.64 to 25.00 0.67(Mann–Whitney)
IOL power (D) 21.38(2.83) 13.50 to 26.50 21.65 (2.90)17.00 to 27.00 0.27(Mann–Whitney)

CDVA corrected distance visual acuity; CNVA corrected near visual acuity; D diopters; Km mean keratometry; IOL intraocular lens; logMAR
logarithm of the minimum angle of resolution; UDVA uncorrected distance visual acuity; UNVA uncorrected near visual acuity. C orresponding P values
for the comparison between groups are shown for each parameter evaluated.

revealed that significantly better visual acuities were present in
group A for the defocus levels of 1.5, 1.0, 1.5, and 2.0 D (Mann–
Whitney test; P#0.04) (Fig 1).
Contrast Sensitivity Outcomes
Postoperatively, the photopic contrast sensitivity was significantly
better for those eyes implanted in group A for the spatial frequen-
cies of 12 and 18 cycles/degree (Mann–Whitney; P#0.04) (Fig 2).
For the rest of the frequencies, a trend to a better postoperative
photopic contrast sensitivity values was observed in group A (Fig
2). In contrast, no statistically significantly differences were de-
tected in low mesopic contrast sensitivity between groups (Mann–
Whitney; P$0.54) (Fig 2).
cally significant differences between groups (Mann–Whitney,
P#0.01) (Table 3).
For postoperative intraocular optical quality (Fig 3), statis-
tically significant differences between groups were found in high-
order RMS, primary spherical aberration, primary coma, and
coma-like RMS (Student t and Mann–Whitney, P#0.02); eyes
from group A presented significantly higher values of these
parameters.
Figure 4 shows a comparative diagram with the analysis of the
intraocular optical quality for a 5.0-mm pupil of 2 cases implanted
with 1 of the 2 IOL models analyzed in this study (left, Lentis Mplus
LS-312; right, Acri.Lisa 366D). These cases are representative of the
general trend observed in the analyzed sample. Both cases presented
similar manifest refractive conditions postoperatively.

Optical Quality Outcomes

The mean ocular Strehl ratio estimated with the OQAS was 0.12
(standard deviation [SD] 0.05) in group A and 0.15 (SD 0.04) in
group B. Differences between groups in this parameter were
statistically significant (Mann–Whitney, P 0.03). The mean cutoff
spatial frequency for the ocular MTF estimated with the OQAS
was 18.31 (SD 9.35) and 24.16 (SD 7.31) in groups A and B,
respectively (Student t, P 0.04).
At 3 months after surgery, significantly higher values of the
total ocular RMS were found in group A (Student t, P 0.01)
(Table 3). For postoperative higher-order RMS, we found statisti-
Discussion
Multifocal IOLs were designed to restore the visual
function and to achieve spectacle independence for far and
near vision after cataract surgery. These IOLs provide some
functional near vision increasing the depth of field of the
1
eye. At present, there are 2 types of multifocal IOLs in
today’s clinical practice: the rotationally symmetric multi-
focal IOL and a new concept of rotational asymmetric
optics characterized by an inferior segmental near add mul-

Table 2. Postoperative Visual and Refractive Outcomes 1 Month after Cataract Surgery in the 2 Groups of Eyes

Mean (SD) Range Group A (Mplus) Group B (Acri.Lisa 366) P Value (Statistical Test)
logMAR UDVA 0.13 (0.20)0.00 to 1.00 0.08 (0.08)0.00 to 0.34 0.66 (Mann–Whitney)
Sphere (D) 0.01 (0.68)3.00 to 1.25 0.14 (0.45)0.75 to 1.25 0.36 (Mann–Whitney)
Cylinder (D) 0.44 (0.55)2.00 to 0.00 0.56 (0.41)1.50 to 0.00 0.07 (Mann–Whitney)
logMAR CDVA 0.03 (0.07)0.00 to 0.30 0.01 (0.02)0.00 to 0.10 0.02 (Mann–Whitney)
logMAR UNVA 0.21 (0.16)0.00 to 0.52 0.11 (0.08)0.00 to 0.30 0.04 (Mann–Whitney)
logMAR DCNVA 0.23 (0.23)0.00 to 0.70 0.05 (0.07)0.00 to 0.22 0.01 (Mann–Whitney)
logMAR CNVA 0.08 (0.09)0.00 to 0.30 0.05 (0.10)0.00 to 0.22 0.23 (Mann–Whitney)
Addition (D) 0.84 (0.76)0.00 to 2.5 0.16 (0.43)0.00 to 1.50 0.01 (Mann–Whitney)

CDVA corrected distance visual acuity; CNVA corrected near visual acuity; D diopters; DCNVA distance corrected near visual acuity; logMAR logarithm
of the minimum angle of resolution; UDVA uncorrected distance visual acuity; UNVA uncorrected near visual acuity. Corresponding P values for the
comparison between groups are shown for each parameter evaluated.

558
 Alio et al Inferior Segmental Near Add vs Diffractive Multifocal IOLs

Table 3. Postoperative Visual and Refractive Outcomes 3 Months after Cataract Surgery in the 2 Groups of Eyes

Mean (SD) Range Group A (Mplus) Group B (Acri.Lisa 366) P Value (Statistical Test)
logMAR UDVA 0.23 (0.47) 0.00 to 2.00 0.06 (0.05)0.00 to 0.15 0.19(Mann–Whitney)
Sphere (D) 0.06 (0.57) 1.00 to 1.25 0.20 (0.44)0.50 to 1.50 0.07(Mann–Whitney)
Cylinder (D) 0.63 (0.61) 2.25 to 0.00 0.49 (0.38)1.25 to 0.00 0.75(Mann–Whitney)
logMAR CDVA 0.08 (0.20) 0.00 to 0.52 0.00 (0.01)0.04 to 0.05 0.01(Mann–Whitney)
logMAR UNVA 0.20 (0.16) 0.00 to 0.62 0.12 (0.11)0.00 to 0.70 0.02(Mann–Whitney)
logMAR DCNVA 0.23 (0.20) 0.00 to 0.80 0.10 (0.12)0.10 to 0.40 0.01(Mann–Whitney)
logMAR CNVA 0.11 (0.12) 0.00 to 0.52 0.07 (0.07)0.00 to 0.22 0.14(Mann–Whitney)
Addition (D) 1.06 (0.79) 0.00 to 2.00 0.39 (0.75)0.00 to 2.75 0.01(Mann–Whitney)
Ocular RMS (mm) 1.82 (0.70) 0.75 to 3.07 1.16 (0.58)0.30 to 2.36 0.04(Student t)
RMS HO (mm) 0.83 (0.43) 0.29 to 2.05 0.48 (0.22)0.14 to 0.94 0.02(Mann–Whitney)

CDVA corrected distance visual acuity; CNVA corrected near visual acuity; D diopters; DCNVA distance corrected near visual acuity; HO high order;
logMAR logarithm of the minimum angle of resolution; RMS root mean square; UDVA uncorrected distance visual acuity; UNVA uncorrected near visual
acuity.
Corresponding P values for the comparison between groups are shown for each parameter evaluated.

11 the highest spectacle freedom. To the best of our knowl-

tifocal IOL. The rotationally symmetric multifocal IOL
includes 3 different technologies: diffractive, refractive,
and hybrid (combination refractive and diffractive). Several
studies have confirmed the efficacy to restore the visual
4 –10
function with rotationally symmetric multifocal IOLs.
However, visual quality problems that may limit the poten-tial
benefit have been reported with some multifocal IOL
5,14,28 –30
models. Specifically, diffractive IOLs are associ-
14,28
ated with photic phenomena such as glare or halos.
Recently, a new concept of multifocal IOL has been intro-
duced in the clinical practice: the refractive inferior seg-
mental near add multifocal IOL. The Lentis Mplus LS-312
11
MF30 is the first commercially available model of IOL
based on this concept. This IOL contains an aspheric
distance-vision zone combined with a 3.00 D posterior
sector-shaped near-vision zone in the inferior area of the
lens, with a seamless transition between the near and
distance zones.
The aim of the current study was to compare the near and
intermediate visual acuity outcomes, defocus curve, and
intraocular optical quality parameters in patients with Lentis
Mplus LS-312 MF30 multifocal IOLs and Acri.Lisa 366D
diffractive multifocal IOLs to ascertain which IOL provides
edge, this is the first study that attempts to compare the
clinical outcomes of this new technology of multifocality
and a diffractive IOL.
In the current study, an improvement in UDVA and CDVA
was found in both groups that confirms the efficacy of the
IOLs for the correction of the patient aphakia ametro-pia. This
was consistent with previous reports by other authors using the
same IOL models (Auffarth GU, Rabsilber TM, Philips R,
Novak J. Oculentis LENTIS Mplus: a new concept of
multifocal intraocular lens technology. XXVII Congress of the
European Society of Cataract and Refrac-tive Surgeons,
4,6,11,28,31,32
September 2009). No statistically significant
differences were found in the UDVA between groups at 1 and
3 months after surgery. However, in clinical terms the UDVA
outcomes obtained in eyes implanted with the diffractive
multifocal IOL were better than the UDVA outcomes obtained
in eyes implanted with the refractive inferior segmental near
add multifocal IOL. In contrast, significant differences
between groups were found in CDVA, with significantly lower
values of CDVA in group A. This fact could be attributed to
the findings in this group

Figure 1. Mean defocus curve in the 2 groups of eyes analyzed: group A,

eyes implanted with the Lentis Mplus LS-312 (red line) (Oculentis GmbH,
Berlin, Germany); group B, eyes implanted with the Acri.Lisa 366D IOL
(green line) (Zeiss, Oberkochen, Germany). D diopters; logMAR
logarithm of the minimal angle of resolution; VA visual acuity.
Figure 2. Mean contrast sensitivity function in the 2 groups of eyes
analyzed: group A, eyes implanted with the Lentis Mplus LS-312 (red
lines); group B, eyes implanted with the Acri.Lisa 366D intraocular (green
2
line). A, Under photopic conditions (85 cd/m ). B, Under mesopic low
2
conditions (3 cd/m ).

559
 Ophthalmology Volume 119, Number 3, March 2016
Figure 3. Postoperative intraocular aberrations calculated with Visual
Optics Lab software version 7.37 (Sarver and Associates, Inc., Celebra-
tion, FL) (group A, red bars; group B, green bars): RMS values (microm-
eters) and standard deviation of total, higher-order, tilt, spherical-like, and
coma-like aberrations. In addition, the primary spherical aberration is also
reported with its sign. HO high order; PSA primary spherical aberration;
RMS root mean square.
of significantly larger amounts of intraocular higher-order
aberrations. The CDVA outcomes obtained in eyes im-
planted with the refractive inferior segmental near add mul-
tifocal IOL are consistent with a previous report (Auffarth
GU, Rabsilber TM, Philips R, Novak J. Oculentis LENTIS
Mplus: a new concept of multifocal intraocular lens tech-
nology. XXVII Congress of the European Society of Cata-
11
ract and Refractive Surgeons, September 2009).
For subjective refraction, no significant reduction in the
manifest cylinder was observed after surgery in either
group. This seems logical because small incisions (MICS)
were used in all cases, and it has been demonstrated that the
use of small corneal incisions in cataract surgery allows the
surgeon to have excellent control of postoperative astigma-
33,34
tism. In addition, no significant differences between
groups were found in the postoperative manifest sphere and
cylinder at 1 and 3 months after surgery. However, a sta-
tistically significant difference with the surgery was found
in manifest sphere for only group B. This finding should be
considered with caution because the subjective refraction in
cataractous patients is not reliable and difficult to obtain
because of the scattering and higher-order aberrations in-
duced by the altered crystalline lens, especially in the most
35–38
advanced cases.
The UNVA improved significantly as expected in both
groups after surgery, and these findings are consistent with
4,6,11,28,31,32
previous studies that analyze these IOLs. Also,
no significant changes were detected in CNVA with surgery in
both groups. When the near visual outcomes between groups
were compared, statistically significant differences were found
in UNVA and DCNVA after surgery, with better results for
group B. These outcomes could be due to the differences of
the multifocality IOL design. The UNVA outcomes obtained
in eyes implanted with the refractive inferior segmental near
add multifocal IOL are slightly poorer than those previously
reported by Auffarth et al (Auffarth GU, Rabsilber TM,
Philips R, Novak J. Oculentis
560
LENTIS Mplus: a new concept of multifocal intraocular
lens technology. XXVII Congress of the European Society
of Cataract and Refractive Surgeons, September 2009).
Also, no statistically significant differences were observed
postoperatively in CNVA between groups. In contrast, sta-
tistically significant differences were detected in near addi-
tion power between groups after surgery with low values
for group B. This confirms the efficacy of the diffractive
mul-tifocal IOL for near vision restoration.
The defocus curve is a useful procedure to test the visual
behavior with a specific model of IOL using different levels of
defocus (equivalent to different viewing distances). In the
current study, we found statistically significant differences
between groups in some levels of defocus as 1 and 1.5
corresponding to the intermediate vision, with better results for
group A. It was demonstrated that the diffractive mul-tifocal
IOLs were able to provide 2 peaks of maximum vision, 1 at
near ( 0 defocus level) and 1 at distance ( 2.5 D defocus level).
In contrast, the inferior segmental near add multifocal IOL
provides only 1 peak of maximum vision ( 0.5 and 3.5 defocus
level), which has a wider range of maximum vision, allowing
the patient to have an acceptable intermediate vision.
Therefore, the refractive in-ferior segmental near add
multifocal IOL provided a wide range of functional vision,
covering the most common working distances. It should be
considered that this IOL presents an inferior segmental near
add, and it may be an IOL design limitation when objects are
held at the eye level or above, because the near segment may
not be available for intermediate and near vision in these
positions.
In addition to contrast sensitivity outcomes, significantly
better results were found for those eyes implanted with the
refractive inferior segmental near add multifocal IOL in
photopic conditions for high spatial frequencies. These out-
11
comes are consistent with previous studies confirming
that contrast sensitivity outcomes with the refractive
inferior segmental near add multifocal IOL are comparable
to a monofocal lens, although other studies prove that
monofo-cal IOLs provided better contrast sensitivity
7,39,40
outcomes than the diffractive multifocal IOLs.
The ocular optical quality with each IOL was evaluated
by means of the OQAS, which has been proved to be valid
32,41– 43
for such purpose. Mean Strehl ratio and cutoff
MTF spatial frequencies were significantly better in those
eyes implanted with the diffractive multifocal IOL,
confirming a superior optical performance than the inferior
segmental near add multifocal IOL. This may be in
concordance with the better near visual outcomes achieved
with the diffractive multifocal IOL.
For postoperative intraocular optical quality, the intraoc-
ular higher-order aberrations were greater in those eyes
implanted with the inferior segmental near add multifocal IOL.
This seems to be in relation with the IOL aspheric design.
24
Previous studies have demonstrated that the Acri.Lisa366D
multifocal IOL induces less spherical aber-ration because of
the aspheric design. Intraocular optical quality outcomes
should be considered with caution because the accuracy of
wavefront aberration measurements is lim-ited in some eyes
44
implanted with diffractive bifocal and multifocal IOLs.
Indeed, a more significant aberrometric
 Alio et al Inferior Segmental Near Add vs Diffractive Multifocal IOLs

Figure 4. Comparative diagram showing the analysis of the in vivo intraocular optical quality for a 5.0-mm pupil of 2 cases implanted with one of both
intraocular lens models analyzed in this study (left, Lentis Mplus LS-312; right, Acri.Lisa 366D). Top: Intraocular wavefront higher-order aberrations.
Middle: Three-dimensional point spread function. Bottom: Snellen optotype simulation considering only the effect of higher-order aberrations. Both cases
presented similar manifest refractive conditions postoperatively.

component may be expected with the Acri.Lisa IOL because
of its diffractive component. However, the levels of intra-
ocular primary coma were significantly greater in those eyes
implanted with the refractive inferior segmental near add
multifocal IOL analyzed in our study. It should be consid-ered
that this IOL presents an inferior segmental near add and that
this geometry in an optical element leads to the induction of
different levels of primary coma depending on the magnitude
45
of this inferior segment. The primary coma, especially large
amounts, has been demonstrated to have a negative impact on
46
visual acuity because of the optical blur it induces, which
may have limited the corrected visual acuity (CDVA and
CNVA) in the group of eyes implanted with the inferior
segmental near add multifocal IOL. These findings are
11
consistent with a previous study in which the tilt or optical
decentration of this IOL increases primary coma and coma-
47– 49
like aberrations after cataract surgery. It may be
possible that the Hartmann-Shack (AMO Wave-Front Science,
Albuquerque, NM) aberrometer is unable to
detect the highest-order aberrations induced by the diffrac-
tive components of the IOLs evaluated. In addition, the
aberrometer used did not provide a quantification of the
forward scattering, which may be more significant with the
multifocal IOLs.
In conclusion, the Lentis Mplus LS-312 and Acri.Lisa
366D IOLs are able to successfully restore visual function
after cataract surgery. However, eyes with the Acri.Lisa 366
IOL showed significantly better intraocular optical quality
parameters and better distance and near visual outcomes. The
presence of intraocular coma and spherical aberration is a
limiting factor for the visual outcomes in eyes implanted with
the Lentis Mplus LS-312. These findings may be related to the
IOL haptic design that might be affected by the capsular bag
retraction because of its softness. In con-trast, the inferior
segmental near add multifocal IOL tech-nology provided a
wide range of focus, especially in the intermediate vision
conditions with less reduction of con-trast sensitivity
outcomes. Therefore, the inferior segmental

561
 Ophthalmology Volume 119, Number 3, March 2016
near add multifocal IOL seems to be a promising
alternative for multifocal IOL implantation because it
offers good levels of near and intermediate vision, better
contrast sen-sitivity outcomes, and a more physiologic
defocus curve. Further studies with the new haptic design,
which is more solid and stable than the C-loop Mplus LS-
312, should be performed in the future to minimize or
eliminate the intra-ocular optical quality problems related
to the IOL position, thus taking better advantage of the
special optical perfor-mance of this IOL. Furthermore, it
would be interesting to test the intermediate and near vision
when objects are held at the eye level or above in the future
to confirm the effectiveness of IOL design.
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Footnotes and Financial Disclosures
Originally received: March 21, 2016.
Final revision: August 22, 2015.
Accepted: August 22, 2015.
Available online: January 3, 2016. Manuscript no. 2011-464.
1 Financial Disclosure(s):
Vissum Corporation, Alicante, Spain.
2 discussed in this article.
Division of Ophthalmology, Universidad Miguel Hernández, Alicante,
Spain.
3 Jorge L. Alio, MD, PhD, Avda de Denia s/n, Edificio Vissum, 03016
Departamento de Óptica, Farmacología y Anatomía, Universidad de
Alicante, Spain.
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image quality after microincision intraocular lens implanta-
tion. J Cataract Refract Surg 2005;31:1557– 60.
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wavefront aberration caused by major tilting of intraocular
lens. Am J Ophthalmol 2005;140:744 – 6.
49. Altmann GE, Nichamin LD, Lane SS, Pepose JS. Optical
performance of 3 intraocular lens designs in the presence of
decentration. J Cataract Refract Surg 2005;31:574 – 85.
This study has been supported in part by a grant from the Spanish Ministry
of Health, Instituto Carlos III, Red Temática de Investigación Cooperativa
en Salud “Patología ocular del envejecimiento, calidad visual y calidad de
vida,” Subproyecto de Calidad Visual (RD07/0062).
The author(s) have no proprietary or commercial interest in any materials
Correspondence:
Alicante, Spain. E-mail: jlalio@vissum.com.
 PERBANDINGAN LENSA INTRAOKULAR MULTIFOKAL REFRAKTIF SEGMENTAL
INFERIOR DENGAN PENAMBAHAN JARAK DEKAT DAN LENSA INTRAOKULAR
MULTIFOKAL DIFRAKTIF

Jorge L. Alio, MD, PhD,1,2 Ana B. Plaza-Puche, MSc,1 Jaime Javaloy, MD, PhD,1,2 María José
Ayala, MD, PhD,1 Luis J. Moreno, MSc,1,2 David P. Piñero, PhD3

Ophthalmology Volume 119, Number 3, March 2016

Pendahuluan
IOL multifokal mengembalikan fungsi visual dan dapat melihat tanpa kacamata untuk
penglihatan jarak jauh dan dekat setelah operasi katarak, ada 2 jenis IOL multifokal di praktik
klinis yaitu IOL dengan fokus rotasi multi-simetris dan konsep baru rotasi optik asimetris
ditandai dengan IOL multifokal segmental inferior dengan penambahan jarak dekat yang
disediakan dengan cakupan luas dari berbagai fungsional penglihatan, meliputi yang paling
umum yaitu fungsi jarak jauh. Sedangkan IOL multifokal difraktif untuk pengembalian fungsi
penglihatan jarak dekat.
Hasil sensitivisitas kontras lebih baik ditemukan untuk mata yang diimplantasikan
dengan IOL multifokal dengan penambahan jarak dekat dengan segmen inferior. Kualitas optic
intraocular pasca operasi, penyimpangan intraokuler tingkat tinggi lebih besar pada mata yang
diimplantasi dengan IOL multifocal dengan penambahan jarak dekat segmen inferior
Selama ini tidak ada penelitian yang membandingkan hasil visual dan kinerja optik
intraokular antara IOL multifokal rotasi simetris dan IOL multifokal refraksi segmen inferior
dengan tambahan jarak dekat. Kinerja optik intraokular adalah studi tentang kualitas gambar dari
intraokular yang dihasilkan oleh struktur intraokular mata. Sensitivitas kontras, fungsi transfer
modulasi (MTF), Strehl ratio, dan analisis penyimpangan optik adalah parameter kualitas optik
yang digunakan untuk mempelajari kinerja optik dari semua jenis lensa. Hasil Pengukuran utama
yaitu ketajaman visual jarak tidak di koreksi (UDVA), ketajaman visual jarak yang terkoreksi
(CDVA), ketajaman Visual jarak dekat tidak terkoreksi (UNVA). Jarak dekat terkoreksi dan
ketajaman tidak terkoreksi, jarak deka terkoreksi dan ketajaman visual menengah (CDNVA)
 Tujuan dari penelitian ini adalah membandingkan hasil visual dan kinerja optik (IOL)

multifokal refraktif inferior segmental dengan jarak dekat atau IOL multifokal difraktif.

Matrial dan Metode

Jarak dikoreksi, menengah dan dekat dengan koreksi (ketajaman visual dan kontras
sensivitas). Kriteria inklusinya adalah pasien katarak inspient atau medium, sedangkan kriteria
ekslusinya adalah penyakit mata aktif, astigmat tofografi 3 di optri

Lensa intraocular
Lentis Mplus LS_312 adalah IOL multifocal segment inferior dengan tambahan jarak
dekat mengandung zona asferis jarak jauh dikombinasi dengan zona 3.00 D jarak dekat
berbentuk sektor posterior, yang memungkinkan transisi tampa batas antar zona.

Tehnik Bedah
 Microincision
 Anastesi local lidokain 2%
 Midazolam
 Siklopentolat 1%, fenilerin 10%, lignokain 2% dan larutan garam (10ml)
 Sayatan dilakukan pada meridian kornea yang paling curam
 ACRi.Lisa, lentisM+
Pemeriksaaan Pra dan Pasca operasi
 Pemeriksaan opthalmologi.
 Teknik double-pass

Analistik statistic
 Uji Kolmogorov-Smirnov
 Uji t student\
 Mann-Whitney
Hasil
Tabel 1. Kondisi Mata Kedua Kelompok Sebelum Operasi

Pada tabel di atas menunjukan tidak signifikan secara statistik perbedaan ditemukan
antara kelompok umur (P=0,22).

Tabel 2. Hasil Visual dan Refraktif 1 bulan setelah Operasi Katarak pada Kedua Kelompok

Terjadi peningkatan yang signifikan pada operasi di UDVA, CDVA, dan UNVA
diamati di kedua kelompok (uji Wilcoxon; P 0,04
 Gambar 1 Kurva Defokus.
Rata-rata kurva defokus dalam 2 kelompok mata yang dianalisis: kelompok A, mata diimplantasi
dengan Lentis Mplus LS-312 (garis merah) (OculentisGmbH, Berlin, Jerman); kelompok B,
mata diimplantasi dengan Acri.Lisa366D IOL (garis hijau) (Zeiss, Oberkochen, Jerman). D
dioptri; logMAR: logaritma sudut resolusi minimal; VA : ketajaman visual.

Gambar 3. Hasil Sensivisitas Kontras.

Penyimpangan intraokular pasca operasi dihitung dengan Visual Optics Lab versi 7.37 (Sarver
and Associates, Inc., Celebration, FL) (kelompok A, baris merah; kelompok B, baris hijau): nilai
RMS (mikrometer) dan standar deviasi dari total, tingkatan tinggi, kemiringan, sferis, dan coma
like aberrations . Selain itu, penyimpangan sferis primer juga dilaporkan dengan tanda yang
sama. HO :high order; PSA: primary spherical aberration; RMS : root mean square.
 Gambar 4. Hasil Kualitas Optik.
Diagram komparatif menunjukkan analisis kualitas optik intraokular in vivo pada pupil 5,0-mm
dari 2 kasus yang diimplantasikan dengan salah satu dari kedua model lensa intraokular yang
dianalisis dalam penelitian ini ( kiri , Lentis Mplus LS-312; kanan , Acri.Lisa 366D). Atas:
Penyimpangan tingkat tinggi permukaan gelombang intraokuler. Tengah: Fungsi penyebaran
titik tiga dimensi. Bawah: Simulasi optotipe Snellen hanya mempertimbangkan efek
penyimpangan tingkat tinggi. Kedua kasus mengalami manifes refraktif yang sama pasca
operasi.

Diskusi
 IOL multifokal untuk mengembalikan fungsi visual dan untuk dapat melihat tanpa
kacamata untuk penglihatan jarak jauh dan dekat setelah operasi katarak
 Ada 2 jenis IOL multifokal di praktik klinis:
IOL dengan fokus rotasi multi-simetris dan konsep baru rotasi optik asimetris ditandai
dengan IOL multifokal segmental inferior dengan penambahan jarak dekat.
 Lentis Mplus LS-312 MF30 adalah model IOL pertama yang tersedia
  IOL ini mengandung zona aspheric penglihatan jarak jauh dikombinasikan dengan 3,00 D
zona posterior jarak dekat berbentuk sektor di daerah inferior lensa
 Tidak ada perbedaan signifikan yang ditemukan di Uncorrected distance visual
acuity (UDVA) antar kelompok pada bulan 1 dan 3 setelah operasi.
 UDVA yang diperoleh di mata yang diimplantasi dengan IOL multifokal difraksi lebih
baik daripada UDVA hasil yang diperoleh pada mata yang diimplantasi dengan IOL
multifokal segmental inferior dengan penambahan jarak dekat.
 Sebaliknya, perbedaan signifikan antar kelompok dtemukan di Corrected distance visual
acuity (CDVA), dengan nilai CDVA secara signifikan lebih rendah pada kelompok A.
 Hasil visual jarak dekat antar kelompok dibandingkan, perbedaan yang signifikan
ditemukan di uncorrected near visual acuity (UNVA) dan distance corrected and near
visual acuity (DCNVA) setelah operasi, dengan hasil yang lebih baik terdapat pada
kelompok B.
 IOL multifokal difraktif untuk pengembalian fungsi penglihatan jarak dekat.
 Perbedaan yang signifikan antar grup dalam beberapa level defokus seperti +1 dan +1.5
yang sesuai dengan pandangan jarak menengah, dengan hasil yang lebih baik untuk
kelompok A.
 Oleh karena itu, IOL multifokal dengan penambahan jarak dekat dengan segmen inferior
disediakan dengan cakupan luas dari berbagai fungsional penglihatan, meliputi yang
paling umum yaitu fungsi jarak jauh.
 Hasil sensitivisitas kontras lebih baik ditemukan duntuk mata yang diimplantasikan
dengan IOL multifokal dengan penambahan jarak dekat dengan segmen inferior
 Kualitas optic intraocular pasca operasi, penyimpangan intraokuler tingkat tinggi lebih
besar pada mata yang diimplantasi dengan IOL multifocal dengan penambahan jarak
dekat segmen inferior

Kesimpulan
Lentis Mplus LS-312 dan Acri.Lisa 366D IOL berhasil mengembalikan fungsi visual
setelah operasi katarak. Dengan IOL Acri.Lisa 366 menunjukkan kualitas parameter optik
intraokular yang jauh lebih baik dan jarak yang lebih baik dan hasil visual yang dekat. Coma
intraokular dan aberasi sferis menjadi keterbatasan untuk hasil visual pada mata yang
diimplantasikan dengan Lentis Mplus LS-312. IOL multifokal dengan penambahan jarak dekat
dengan segmen inferior terbaik pada kondisi penglihatan jarak menengah.