Visual Outcomes and Accommodative

Response of the Lumina Accommodative

Intraocular Lens

JORGE L. ALIO, ALEKSEY SIMONOV, ANA BELÉN PLAZA-PUCHE, ALEXANDER ANGELOV, YAVOR ANGELOV,
WILLEM VAN LAWICK, AND MICHIEL ROMBACH

PURPOSE: To compare visual acuity, accommodation, and 0.10 ± 0.15, 0.12 ± 0.15, L0.06 ± 0.09 and
and contrast sensitivity of the AkkoLens Lumina accom- 0.07 ± 0.10 D for the control group at accommodation
modative intraocular lens (AkkoLens Clinical b.v., stimuli of 2.0, 2.5, 3.0, and 4.0 D, respectively. Contrast
Breda, The Netherlands) with a standard monofocal sensitivity was the same for both groups (P ‡ .26).
intraocular lens (IOL).
CONCLUSIONS: The Lumina accommodative IOL

DESIGN: Randomized clinical trial. effectively restores the visual function, accommodation,

METHODS: The study enrolled 86 eyes with cataract and contrast sensitivity after cataract surgery with no
that all required cataract surgery and IOL implantation. influence on the postoperative contrast sensitivity. (Am
The study group included 61 eyes that were implanted J Ophthalmol 2016;164:37–48. Ó 2016 by Elsevier Inc.
with the Lumina. The control group included 25 eyes All rights reserved.)
that were implanted with an Acrysof SA60AT (Alcon,
Fort Worth, TX, USA) monofocal IOL. The distance

R
and near visual acuities, contrast sensitivity, and accom- ECENTLY NEW TYPES OF INTRAOCULAR LENSES
modation were measured over a 1-year follow-up period. (IOLs), including multifocal lenses and truly
Accommodation was measured subjectively, using defocus accommodating lenses, have become available, all
curves, and objectively, with an open-field autorefractor. of which aim to offer spectacle independence to the

RESULTS: Uncorrected (UDVA) and corrected patient1–14 by providing adequate uncorrected distance
(CDVA) distance visual acuities did not differ signifi- vision in combination with adequate uncorrected
cantly between the groups (P ‡ .21) over the 12 months. intermediate and near vision.
However, the uncorrected near visual acuity (UNVA) Truly accommodating lenses adjust focus for different dis-
was 0.07 ± 0.08 logRAD for the Lumina group and tances. Different concepts for accommodating lenses were
0.37 ± 0.19 logRAD for the control group (P < .01) proposed.7 One concept employs axial shift of a fixed-
and the corrected distance near visual acuity (CDNVA) power lens in the eye. Forward and backward movement of
was 0.11 ± 0.12 LogRAD for the Lumina group and such lens along the optical axis, a movement caused by the
0.41 ± 0.15 LogRAD for the control group (P < .01). ciliary muscle, was expected to change the eye’s dioptric po-
Defocus curves showed a statistically significant differ- wer. However, several studies4,15–17 now show that such
ence between groups for defocus ranging from L4.50 axial-shifting lenses provide only limited, or no, improve-
to L0.50 diopters (D) (P < .01) with significantly ment in near vision. The other concept is based on curvature
higher visual acuities for the Lumina group. Subjective change, which changes the refractive power of the lens.7,18
accommodation, as determined from defocus curves, An intraocular lens can be positioned inside the capsular
was 3.05 ± 1.06, 3.87 ± 1.27, and 5.59 ± 1.02 D for bag or, alternatively, can be positioned at the sulcus plane,
the Lumina group and 1.46 ± 0.54, 2.00 ± 0.52, and in front of the bag. It was reported that capsular fibrosis in
3.67 ± 0.75 D for the control group at visual acuities of primate eyes can noticeably hamper lens movement with
0.10, 0.20, and 0.4 logMAR for both groups, respec- the lens in the capsular bag after only several months
tively. The objective accommodation, measured by an postoperatively. A sulcus placement separates the lens
open-field autorefractor, was 0.63 ± 0.41, 0.69 ± 0.45, from the bag and thus reduces the risk of the adverse
0.91 ± 0.51, and 1.27 ± 0.76 D for the Lumina group reactions owing to the postoperative capsular bag fibrosis,
hardening, and shrinkage.18,19
In this paper we report the results of a clinical study with
Supplemental Material available at AJO.com. the Lumina accommodative lens. The Lumina is designed
Accepted for publication Jan 23, 2016.
From Vissum Alicante, Alicante, Spain (J.L.A., A.B.P.-P.); Division of for positioning at the sulcus plane, but the haptics on the
Ophthalmology, Universidad Miguel Hernández, Alicante, Spain (J.L.A.); flanges rest on top of the ciliary mass and do not
AkkoLens Clinical b.v., Breda, Netherlands (A.S., W.v.L., M.R.); and significantly extend into the sulcus. The Lumina optical
Resbiomed-Vissum Sofia Eye Clinic, Sofia, Bulgaria (A.A., Y.A.).
Inquiries to Jorge L. Alio, Calle Cabañal, 1, Edificio Vissum, 03016 arrangement encompasses variable-focus optics according
Alicante, Spain; e-mail: jlalio@vissum.com to Alvarez20,21 and additional free-form surfaces to reduce

0002-9394/$36.00 Ó 2016 BY ELSEVIER INC. ALL RIGHTS RESERVED. 37

http://dx.doi.org/10.1016/j.ajo.2016.01.006
 causing a significant reduction of vision, plus eyes with no
other ocular comorbidity, plus eyes with an expected posi-
tive effect of the surgery on the visual outcome, plus eyes
with no previous ocular surgeries in the eye selected for
the study. The other eye of the patient should present a
normal condition, absence of any sight-threatening ocular
comorbidity, no cataract, or a healthy pseudophakic eye.
Only patients with less than 2 diopters (D) of corneal astig-
matism were included in the study with no significant
corneal irregularities as measured by corneal topography
(Atlas 9000; Zeiss) and with axial lengths ranging from
21.5 to 25.0 mm (IOLMaster; Zeiss).
The randomization procedure was as follows: (1) a
randomized table of study lenses and control lenses was
prepared at the start of the study, and (2) once a patient
signed the informed consent this patient was automatically
FIGURE 1. Optical principle of the Lumina intraocular lens.
assigned the next slot in the randomized table. All eyes un-
(Top) Overlapping optical elements result in low optical power derwent largely standard cataract surgery. In total, 94 eyes
and the lens focuses light from a distant object onto the image were screened, resulting in 86 randomized eyes because of
plane; (Bottom) shifted optical elements increase the optical power randomization failures and withdrawal of informed consent.
and the lens focuses light from a near object onto the image plane. During the study, 3 control eyes and 2 Lumina eyes had early
discontinuation because the patients passed away. In 1 case a
posterior capsular tear occurred in an eye to be implanted
with the Lumina during the surgery. This eye was therefore
undesirable variable aberrations of the lens.22 The 2 optical
implanted with a 3-piece MA60 Acrysof Alcon lens (Alcon,
elements of the Lumina slide in a plane perpendicular to
Fort Worth, TX, USA) at the sulcus plane.
the optical axis and produce a continuous variable-focus
By the design of the clinical trial, 61 eyes were assigned
lens (Figure 1). The lens is positioned in the sulcus plane
to a study group, implanted with the Lumina accommoda-
in front and on top of the capsular bag and is driven
tive intraocular lens (AIOL; AkkoLens international b.v.,
directly, without interference of the capsular bag, by the
Breda, The Netherlands), and 25 eyes were assigned to a
ciliary muscle. This allows the eye to focus continuously
control group implanted with a standard monofocal IOL
from far to near.
(Acrysof SA60AT; Alcon, Fort Worth, TX, USA).
The unequal sample sizes resulted from the 2-phase
design of the clinical investigation according to the
METHODS recommendations of the ANSI Z80 committee (Z80.29,
Rev 016, Annex B, November 2011). In compliance with

PATIENTS: This prospective, consecutive, comparative, the recommendations, a performance endpoint of 1 D of
and randomized clinical trial included 94 eyes of patients objective accommodation should be demonstrated in phase
aged between 43 and 85 years implanted either with the I, with w40 study eyes at 4–6 months postoperatively, prior
Lumina lens or with a monofocal control IOL. Patients to phase II, when the majority of controls are implanted for
were informed about the purpose of the study and signed the following comparative analysis.
the informed consent form. The study complied with the All eyes in the present clinical trial were evaluated at 5 reg-
tenets of the Declaration of Helsinki and it was approved ular postoperative visits during a follow-up period of 12 months.
by the Competent Authorities (CA) in Bulgaria, including
the Ethics Committee for Multicenter Clinical Trials
INTRAOCULAR LENSES: Figure 2 shows the Lumina
(ECMCT) of the Ministry of Health of Bulgaria (applica- study lens, which is designed and produced by AkkoLens
tion No. KI-1097/07.11.2012, study protocol no. 1101- Clinical, The Netherlands. The lens consists of 2 optical
016 v04) and the Bulgarian Drug Agency (permission no. elements, each having an elastic, U-shaped loop with a
KI-MI-0007/26.11.2012 for the prospective clinical study spring function, and nonelastic connections to the main
in compliance with the same protocol) and, thus, registered body of the lens. The lens is positioned at the sulcus plane
with the European Medicines Agency (30 Churchill Place, and the ciliary muscle contacts the body of the lens and
Canary Wharf, London E14 5EU, UK). The study also drives accommodation directly. The optics of the Lumina
complied with the HIPAA requirements and was provides a fixed optical power to correct the refractive error
completed within the required timeframe. of the aphakic eye. The fixed power is distributed over the 2
The following eyes were included in the study: eyes with aspheric optical elements, with the anterior element
clinical cataract (Lens Opacities Classification System III), providing 5.0 D and the posterior element 10–25 D, which

38 AMERICAN JOURNAL OF OPHTHALMOLOGY APRIL 2016

 The size of the Lumina is customized for each patient eye
based on the measured sulcus-to-sulcus diameter, by OCT
(Visante OCT; Zeiss), at the 12 o’clock meridian
(90-degree positions). This method allows an accurate
estimation of the distance between the uttermost peripheral
edges of the iris pigmentary epithelium, in that particular
meridian, from the color-coded OCT images of the eye.23
Figure 3 shows positioning of the Lumina at the sulcus
plane by ultrasound biomicroscopy images. The fixed
optical power of the lens (ie, the power required for an emme-
tropic eye) was calculated from optical biometry (IOL Master;
Zeiss) by using proprietary Cþþ software integrated with
FIGURE 2. The Lumina intraocular lens. Zemax ray-tracing software (Zemax, USA). The Lumina
lenses were manufactured by CNC diamond lathing from
Contaflex CI26 material (Contamac, UK), a widely used
biocompatible hydrophilic acrylic polymer containing a
UV-blocking agent. The Acrysof SA60AT control lens is a
monofocal spheric acrylic foldable single-piece lens with an
optic diameter of 6.0 mm and an overall diameter of 13.0 mm.
This investigation was preceded by a pilot feasibility
study, also performed at Vissum Alicante, with 8 Lumina
lenses. These eyes were implanted by the same surgeon
(J.L.A.) in partially sighted eyes. These eyes are now
followed up for more than 5 years and have shown no sig-
nificant adverse events to date.

SURGICAL TECHNIQUE: All surgeries were performed by

J.L.A. at the Resbiomed-Vissum Eye Clinic in Sofia,
Bulgaria. Procedures included phacoemulsification,
retrobulbar anesthesia, and, in all cases, mild sedation with
midazolam. Adequate dilation was with intracameral mydri-
asis of 0.1 mL of a vial containing cyclopentolate 1%, phen-
ylephrine 10%, lignocaine 2%, and a balanced saline
solution (BSS, 10 mL). The incision was at the w12 o’clock,
90 degree position in all eyes. The Lumina was implanted
through a 2.8- to 3.0-mm incision in the sulcus plane of
the eye by using a standard disposable injector system with
an adapted, proprietary, AkkoLens butterfly cartridge. The
FIGURE 3. Ultrasound images of the eye with the Lumina Acrysof SA60AT control lenses were implanted in the
intraocular lens: (Top) superimposed contour of the lens; capsular bag by a suitable injector. The IOL spherical power
(Bottom) implanted lens.
was calculated by a standard method for the control lenses
and by ray-tracing (as explained above) for the Lumina
lenses, respectively, to reach emmetropia in both groups.
power depends on the required correction of the eye. Postoperative topical therapy included a combination of
A variable optical power results from 2 mutually shifted topical antibiotics (ofloxacin 0.3% [Exocin]) and a steroid
internal aspheric surfaces whose power increases linearly (dexamethasone 0.1%, Maxidex; Alcon, Spain). A video
with the shift. clip (Supplemental Material available at AJO.com) shows
In the unaccommodated eye, with the eye focused at far, the implantation of the Lumina AIOL.
the ciliary muscle has the largest diameter. The U-shaped
springs of the Lumina are relaxed, the optical elements
OCULAR EXAMINATIONS: All eyes underwent preopera-
overlap, the lens shows its lowest optical power, and its tive evaluation including measurements of refraction, kera-
optical diameter is w5.7 mm. When the eye accommo- tometry, distance and near visual acuities, slit-lamp
dates, the ciliary muscle contracts and compresses the examination, tonometry, and examination of the fundus.
Lumina, resulting in mutual shift of the optical elements. Distance visual acuity was measured under photopic condi-
The optical power increases linearly with the shift and tions at 4 meters with standard Snellen charts and by a
the eye focuses at closer distances. computerized LCD chart system (CC-100XP; Topcon).

VOL. 164 VISUAL PERFORMANCE OF THE LUMINA ACCOMMODATIVE IOL 39

Additional measurements included corneal topography
(Atlas 9000; Zeiss), anterior segment optical coherence to- TABLE 1. Comparative Summary of Preoperative Conditions
mography (Visante OCT; Zeiss), and posterior segment opti- of Patients Included in the Lumina Intraocular Lens Group
and the Monofocal Control Group
cal coherence tomography (Cirrus OCT; Zeiss). The
procedures and test conditions complied with the require- Lumina Intraocular Monofocal Control P
ments of the EN ISO 11979-7 standard (Ophthalmic im- Parameter Lens Lens Value
plants – Intraocular lenses – Part 7: Clinical investigations)
Age (y) 69.44 (8.67) 67.52 (9.58) .44
and the recommendations of the ANSI Z80 committee. 46–85 43–80
Patients were masked for the investigator carrying out Sphere (D) 1.40 (2.66) 0.81 (2.87) .64
the evaluations, meaning that the investigator was not 11.00 to þ2.25 5.00 to þ3.00
informed as to whether the patient was implanted with Cylinder (D) 1.02 (0.43) 0.90 (0.42) .65
the study lens or the control lens. The patients were 2.00 to 0.50 1.50 to 0.50
masked at the beginning of the study, but some patients Mean keratometry 43.60 (1.32) 43.80 (1.94) .53
found out that they had received an accommodative IOL (D) 40.91–46.78 40.62–48.26
once they started to accommodate. Eyes were assessed at Axial length 23.68 (0.65) 23.34 (0.49) .08
1 day, 1 month, 3 months, 6 months, and at 12 months 22.34–25.00 22.50–24.27

postoperatively. In addition to the measurements listed in D ¼ diopters; SD ¼ standard deviation.

the preoperative protocol, the postoperative protocol Data are presented as mean (SD), range.
included additional assessments of near visual acuity
using Radner reading charts (logarithm of reading acuity
determination, logRAD) and contrast sensitivity.
Monocular defocus curves were obtained with distance
TABLE 2. Comparative Summary of the 1-Month-
refractive correction under low ambient light to keep an Postoperative Data of Patients Included in the Lumina
open pupil to minimize the undesirable effect of extended Intraocular Lens Group and the Monofocal Control Group
depth of focus owing to a small pupil, which can mask true
accommodation. Negative and positive spherical lenses Lumina Intraocular Monofocal Control
Parameter Lens Lens P Value
were added in 0.50-D steps, producing a stimulus for the
eye to accommodate in the range from 5.00 to þ2.00 D. LogMAR UDVA 0.24 (0.36) 0.06 (0.11) .21
The means of the measured visual acuities are summarized 0.08 to 1.40 0.08 to 0.30
in mean defocus curves in which the measurements at 0.00 Sphere (D) 0.27 (1.10) þ0.52 (0.81) <.01
D and 2.50 D correspond to corrected distance visual acuity 4.75 to þ2.00 1.25 to þ1.50
Cylinder (D) 1.39 (0.79) 1.02 (0.60) .17
(CDVA) and corrected distance near visual acuity
4.25 to 0.25 2.00 to 0.00
(CDNVA), respectively, and intermediate visual acuity cor-
LogMAR CDVA 0.05 (0.26) 0.00 (0.06) .73
responds to the measurement at 1.50 D. Depth of focus was 0.08 to 1.40 0.08 to 0.10
evaluated from defocus curves at the levels of visual acuity of LogRAD 0.13 (0.14) 0.35 (0.16) <.01
0.10, 0.20, and 0.40 logMAR. The depth of focus for a partic- UNVA 0.00–0.52 0.00–0.52
ular eye was defined as the width of the defocus curve, in di- LogRAD CDNVA 0.12 (0.20) 0.37 (0.18) <.01
opters, at a given level of visual acuity. 0.08 to 1.00 0.10–0.52
Objective accommodation was measured by measuring LogRAD 0.02 (0.08) 0.06 (0.13) .51
the refractive power of the eye with the open-field autore- CNVA 0.08 to 0.30 0.08 to 0.40
fractor Grand Seiko WAM-5500 (Grand Seiko, Japan).
CDNVA ¼ corrected distance near visual acuity; CDVA ¼
The WAM allows continuous measurement of the eye
corrected distance visual acuity; CNVA ¼ corrected near visual
refraction (at about 5 times per second) while the patient acuity; D ¼ diopters; logMAR ¼ logarithm of minimal angle of res-
looks at an approaching target through an open-field olution; logRAD ¼ logarithm of reading acuity determination;
semi-transparent screen. During the measurement the pa- SD ¼ standard deviation; UDVA ¼ uncorrected distance visual
tient was provided, if necessary, with standard spectacles acuity; UNVA ¼ uncorrected near visual acuity.
to correct for distance vision. An approaching target, a Data are presented as mean (SD), range.
reading chart, was mounted on a sliding stage and provided
accommodative stimuli of 2.00, 2.50, 3.00, and 4.00
D. The pupil size was continuously measured by the WAM. Windows, version 15.0; SPSS, Chicago, Illinois, USA). The
Contrast sensitivity of distance corrected eyes was measured normality of all data samples was evaluated by the
with the Topcon LCD display at the spatial frequencies Kolmogorov-Smirnov test. The Student t test was used for
of 1.50, 3.0, 6.0, 12.0, and 24.0 cycles/degree (cpd). the parametric analysis of both paired data, for example com-
parison of preoperative and postoperative data of the same eye,

STATISTICAL ANALYSIS: The statistical analysis was and for unpaired data, for example comparison between
performed by the SPSS statistics software (SPSS for groups. When the parametric analysis was not possible, the

40 AMERICAN JOURNAL OF OPHTHALMOLOGY APRIL 2016

 TABLE 3. Comparative Summary of 6-Months- TABLE 4. Comparative Summary of 12-Months-
Postoperative Data of Patients Included in the Lumina Postoperative Data of Patients Included in the Lumina
Intraocular Lens Group and the Monofocal Control Group Intraocular Lens Group and the Monofocal Control Group

Lumina Intraocular Monofocal Control Lumina Intraocular Monofocal Control

Parameter Lens Lens P Value Parameter Lens Lens P Value

LogMAR UDVA 0.11 (0.22) 0.02 (0.06) .74 LogMAR UDVA 0.04 (0.11) 0.06 (0.18) .93
0.08 to 0.70 0.08 to 0.10 0.18 to 0.30 0.18 to 0.52
Sphere (D) 0.20 (0.99) þ0.88 (0.94) .11 Sphere (D) þ0.35 (1.01) þ1.03 (1.05) .06
1.50 to þ2.50 0.25 to þ2.25 1.75 to þ2.50 0.75 to þ3.25
Cylinder (D) 1.30 (0.79) 1.06 (0.37) .47 Cylinder (D) 1.20 (0.67) 1.01 (0.57) .45
3.75 to 0.00 1.50 to 0.50 2.50 to 0.00 2.00 to 0.00
LogMAR CDVA 0.02 (0.07) 0.01 (0.08) .65 LogMAR CDVA 0.04 (0.05) 0.04 (0.07) .70
0.18 to 0.22 0.08 to 0.22 0.18 to 0.00 0.18 to 0.05
LogRAD UNVA 0.08 (0.12) 0.40 (0.12) <.01 LogRAD UNVA 0.07 (0.08) 0.37 (0.19) <.01
0.20 to 0.30 0.22–0.52 0.00–0.22 0.00–0.70
LogRAD CDNVA 0.11 (0.12) 0.39 (0.16) <.01 LogRAD CDNVA 0.11 (0.12) 0.41 (0.15) <.01
0.08 to 0.40 0.00–0.52 0.00–0.52 0.00–0.52
LogRAD CNVA 0.01 (0.06) 0.03 (0.12) .40 LogRAD CNVA 0.02 (0.04) 0.01 (0.04) .23
0.20 to 0.15 0.08 to 0.40 0.10 to 0.10 0.08 to 0.10

CDNVA ¼ corrected distance near visual acuity; CDVA ¼ CDNVA ¼ corrected distance near visual acuity; CDVA ¼
corrected distance visual acuity; CNVA ¼ corrected near visual corrected distance visual acuity; CNVA ¼ corrected near visual
acuity; D ¼ diopters; logMAR ¼ logarithm of minimal angle of res- acuity; D ¼ diopters; logMAR ¼ logarithm of minimal angle of res-
olution; logRAD ¼ logarithm of reading acuity determination; olution; logRAD ¼ logarithm of reading acuity determination;
SD ¼ standard deviation; UDVA ¼ uncorrected distance visual SD ¼ standard deviation; UDVA ¼ uncorrected distance visual
acuity; UNVA ¼ uncorrected near visual acuity. acuity; UNVA ¼ uncorrected near visual acuity.
Data are presented as mean (SD), range. Data are presented as mean (SD), range.

Wilcoxon rank-sum test was applied to assess the significance differences in age, mean keratometry, or axial length
of differences between preoperative and postoperative data, (P >_ .08) between the control and the study groups.
whereas the Mann-Whitney test was used to compare the pa-
rameters between groups. A level of significance of P < .05 was
VISUAL AND REFRACTIVE OUTCOMES: Tables 2, 3,
applied to all tests. Main outcomes measures were distance and and 4 show the visual and refractive outcomes at 1 month,
near visual acuities, defocus curve, objective accommodation 6 months, and 12 months after surgery, respectively. There
in diopters, depth of focus, and contrast sensitivity function. are no statistically significant differences in uncorrected
distance visual acuity (UDVA) and CDVA between groups
during postoperative evaluation (P > _ .21). At 12 months,
RESULTS the cumulative CDVA shows that 100% of eyes in both
groups reached a CDVA of 0.10 logMAR. The values of
ALL EYES WERE EVALUATED OVER 1 YEAR POSTOPERA- UDVA were 0.04 6 0.11 logMAR and 0.06 6 0.18
tively. No relevant complications occurred during this logMAR in the Lumina and control groups, respectively,
study except in the 1 eye, mentioned earlier, that received after 12 months postoperatively. However, the results
the control lens instead of the Lumina. show statistically significant differences in uncorrected
Intraocular inflammation other that the one normally near visual acuity (UNVA) and in CDNVA with signifi-
observed postoperatively following cataract surgery did not cantly higher near visual acuities for the Lumina group
occur in this study or in the preceding safety trial with a >4- (P < .01) compared to the control group. Figure 4
year follow-up period. During the study, 10 Lumina eyes had represents the cumulative CDNVA at 12 months after sur-
to be treated after 3–12 months for posterior capsule opacifica- gery; 90.32% of eyes in the Lumina group and 0% of eyes in
tion (PCO) by a standard yttrium-aluminum-garnet (YAG) the control group showed a CDNVA of 0.10 logMAR. The
capsulotomy. After the YAG treatment visual acuity and ac- UNVA was 0.07 6 0.08 logMAR and 0.37 6 0.19 logMAR
commodation were restored almost immediately. No cases led for Lumina and control groups, respectively, 12 months af-
to a chronic increase in intraocular pressure. Pigment particles ter surgery. The CDNVA were 0.11 6 0.12 logMAR and
adhering to the top of the iris were observed in some patients; 0.41 6 0.15 logMAR in the Lumina and control groups,
these particles had no medical consequences. respectively, 12 months after surgery.
Table 1 shows the preoperative conditions of patients The groups did not show a statistical difference in
included in this study. There were no statistically significant corrected near visual acuity (CNVA) at 1, 6, and 12 months

VOL. 164 VISUAL PERFORMANCE OF THE LUMINA ACCOMMODATIVE IOL 41

FIGURE 4. Cumulative distance-corrected near visual acuity at 12 months after surgery: (black bars) the Lumina intraocular lens
group; (gray bars) the monofocal control group.

FIGURE 5. Accuracy of spherical equivalent at 12 months after surgery: (black bars) the Lumina intraocular lens group; (gray bars)
the monofocal control group.

postoperatively (P > _ .23). In both groups, the UDVA and at later follow-up visits (P >
_ .17, Tables 2–4). The manifest
CDVA values improved significantly after cataract surgery sphere and cylinder did not demonstrate statistically
(P <_ .03). The Lumina study group shows a statistically significant changes during the follow-up in both groups (P
significant difference in UDVA and UNVA at 1 and >
_ .08). Twelve months after surgery the manifest sphere
6 months postoperatively, with higher values at 6 months was þ0.35 6 1.01 D and þ1.03 6 1.05 D for Lumina and
postoperatively (P < _ .02). control groups, respectively. The manifest cylinder
Postoperative manifest refraction shows a statistically sig- 12 months postoperatively was 1.20 6 0.67 D
nificant difference between groups in sphere at 1 month after and 1.01 6 0.57 D for Lumina and control groups, respec-
the surgery (P < .01). This difference, however, lessened and tively. A total of 69.8% and 72.7% of eyes achieved a spher-
disappeared over time (P > _ .06). No statistically significant ical equivalent within 61.00 D for the Lumina and control
differences were found between groups in manifest cylinder groups, respectively (Figure 5).

42 AMERICAN JOURNAL OF OPHTHALMOLOGY APRIL 2016

FIGURE 6. Mean postoperative contrast sensitivity: (black curve) the Lumina intraocular lens group; (gray curve) the monofocal
control group.

FIGURE 7. Mean postoperative defocus curves at 12 months: (black curve) the Lumina intraocular lens group; (gray curve) the
monofocal control group.

CONTRAST SENSITIVITY: Figure 6 shows the mean visual acuities for the Lumina study group. Also, the study
mesopic contrast sensitivity. There were no statistically group demonstrated a statistically significant higher depth
significant differences between the Lumina group and the of focus (P < .01) for visual acuities of 0.10, 0.20, and 0.4
monofocal control group (P > _ .26). logMAR, as shown in Figure 8.

DEFOCUS CURVES: Figure 7 shows the mean defocus
OBJECTIVE ACCOMMODATION MEASUREMENT: Figure 9
curves for the 2 groups. Defocus data exhibited a statistically shows the mean objective accommodative response of the
significant difference between the groups in the stimulus eyes to the accommodation stimulus ranging from 0.00
range from 4.50 to 0.50 D (P < .01) with higher mean to 4.00 D for both groups. The objective accommodations

VOL. 164 VISUAL PERFORMANCE OF THE LUMINA ACCOMMODATIVE IOL 43

FIGURE 8. Depth of focus for the 3 levels of visual acuity: (black bars) the Lumina intraocular lens group; (gray bars) the monofocal
control group.

FIGURE 9. Mean postoperative objective accommodation: (black curve) the Lumina intraocular lens group; (gray curve) the mono-
focal control group.

for the Lumina group were 0.63 6 0.41 D, 0.69 6 0.45 mean objective amplitude of accommodation in the Lumina
D, 0.91 6 0.51 D, and 1.27 6 0.76 D and for the control eyes exceeded 1 D at a 4.00 D stimulus. Figure 10 depicts
group were 0.10 6 0.15 D, 0.12 6 0.15 D, 0.06 6 0.09 the mean pupil diameter obtained in the same experiments.
and 0.07 6 0.10 D for the accommodation stimuli of 2.0, The averaged pupil diameters were 4.11 6 0.87 mm and
2.5, 3.0, and 4.0 D, respectively. Statistically significant dif- 4.01 6 1.19 mm in the study and control group, respectively,
ferences were found between the groups at accommodation with no statistical difference between the groups (P ¼ .60).
stimuli of 2.00, 2.50, 3.00, and 4.00 D (P < .01), with Figure 11 illustrates a typical accommodative response
higher values for the Lumina patients. It can be seen that the of a Lumina patient (Top) and a monofocal patient

44 AMERICAN JOURNAL OF OPHTHALMOLOGY APRIL 2016

FIGURE 10. Mean pupil diameter in accommodation: (black curve) the Lumina intraocular lens group; (gray curve) the monofocal
control group.

(Bottom) obtained with the WAM-5500 without distance WAM-5500 (Grand Seiko), which provides repeatability
correction. and accuracy of refractive measurements.24–26
To confirm that the Lumina optical elements move in The Lumina study group and the standard monofocal
accommodation, a video from the WAM-5500 video control IOL group did not show statistically significant
output was recorded illustrating the reflections of the differences in distance visual acuity. One may conclude,
probe (infrared) beam of the autorefractor from the sur- therefore, that the Lumina restores the distance vision
faces of the Lumina. Such reflections were indeed similarly to the monofocal control lens. Comparable
observed. In this experiment, a Lumina patient had no distance visual acuities were reported for other models of
correcting spectacles and a moving target toward the AIOLs.15–17,24 However, the Lumina demonstrates better
eye produced the dynamic stimulus. Figure 12 shows 4 near visual acuity and, thus, provides rehabilitation of
consecutive frames of the video to illustrate changes in near vision in contrast to these other models. CDNVA
reflections in accommodation. values were used to assess near visual acuities to exclude
the effect of postoperative residual refraction.
Improvements in UDVA and UNVA for the Lumina
group between 1 and 6 months follow-up were likely related
to neuroadaptation, related to a ‘‘learning curve.’’ Statisti-
DISCUSSION cal differences were found between the groups in spherical
refractive error with negative values, meaning myopia, for
ACCOMMODATIVE INTRAOCULAR LENSES CAN BE BASED the study group at 1 month postoperatively, with myopia
either on axial shift of 1 or 2 optical elements or on cur- decreasing over time. This probably reflects the evolution
vature change of the lens. However, lenses based on axial of the accommodative state of the lens after surgery, which
shift provide only limited accommodative power. For can be influenced by the tonus of the ciliary muscle or by
example, previous studies15,17 did not show significant minor changes in the lens position. Postoperative manifest
additional objective accommodation by the Crystalens cylinder refractions in both groups did not show statistical
HD single optic AIOL (Bausch and Lomb, USA) or by difference over the whole follow-up period.
the Synchrony dual optic AIOL (AMO, USA) when A hyperopic shift of 1.03 D was observed in the monofo-
compared to a standard monofocal IOL. cal group and a hyperopic shift of 0.35 D was found in the
In the present study, we compared the Lumina (AkkoLens Lumina group (Table 4). So, the monofocal group has a bias
Clinical) with a monofocal IOL (SA60AT, Alcon) and of þ0.68 D in the UNVA test compared to the Lumina
presented the results of a 1-year clinical study, including results group, which adds about 0.1 logRAD units to reading
on distant and near visual outcomes, subjective and objective acuity of the monofocal group, as can also be estimated
accommodation, and contrast sensitivity. The objective ac- from Figure 5. This bias falls within the standard deviation
commodation was measured with an autorefractor, the interval for the Lumina group (Table 4). In the monofocal

VOL. 164 VISUAL PERFORMANCE OF THE LUMINA ACCOMMODATIVE IOL 45

 visual acuity in the Lumina eyes exceeds the levels
reported for other AIOLs,15 especially in the range
from 3.50 D to 1.00 D.
The document EN ISO 11979-7: 2014 and the recent
recommendations of the ANSI Z80 committee require
the use of objective methods for assessing accommodation
amplitude. The measurements must be performed either by
biometric methods (ultrasound biomicroscopy, OCT) or by
optical refractive methods (autorefractors, wavefront
aberrometers). Autorefractors with an open field of view
are the most common devices to objectively measure
accommodation of the eye in response to accommodative
stimuli.25,26 In a trial of a new AIOL, it is advisable to
compare only the results obtained with identical devices
under the same testing conditions.
In the present study, objective accommodative
amplitudes were measured by WAM-5500 under
compelling accommodative stimuli. In spite of the unequal
group sizes reducing the statistical power of the compari-
son, the measurements clearly show that the Lumina
AIOL produces a significantly higher accommodative
response compared to the monofocal IOL. The absolute
difference can be even greater when an accommodation
lag of w0.75 D, according to the WAM-5500 manual, is
taken into account.
The Lumina and control group did not statistically differ
in contrast sensitivity, which agrees with previous studies
on other single-piece AIOLs.16,27,28 Several investigations
were performed to compare contrast sensitivity in the
patients implanted with single-piece AIOLs and multifocal
IOLs,29,30 which showed that AIOLs provide higher
contrast sensitivity in comparison to multifocal
lenses.29,30 Thus, in the present study the eyes implanted
with the Lumina show proper near vision restoration,
FIGURE 11. Examples of objective accommodative responses accommodation, and restoration of contrast sensitivity.
measured by the WAM-5500 autorefractor: (Top) an eye
The Lumina is implanted in the sulcus plane with the
with the Lumina intraocular lens; (Bottom) an eye with the
monofocal control lens.
ciliary muscle in direct contact with the spring-loaded
moving optical elements of the Lumina. The elements
move in opposite directions, which increases the optical
power of the lens when the eye accommodates and the
group the value of CDNVA reduces by 0.04 D logRAD muscle contracts. When the muscle relaxes to focus at
units as compared to UNVA, which can be explained by further distances, the springs force the elements back to
the small sample size (n ¼ 25) of the group. The standard their original state, which decreases the optical power.
deviation (SD) of the mean UNVA is 0.19 and the SD of The Lumina is not affected by the capsular bag–related
the mean CDNVA is 0.15. Thus, it can be concluded effects, such as fibrosis and hardening and shrinking of
that the mean values are overlapping and that the distance the bag, because the Lumina is positioned at the sulcus
correction of the monofocal controls does not lead to plane, in front of the bag. During the study, 10 Lumina
significant increase in near visual acuity. eyes had to undergo a standard YAG capsulotomy due
Mean defocus curve for the eyes implanted with the to PCO after 3–12 months postoperatively. After YAG
Lumina shows a significantly broader profile as compared treatments, the visual acuity and accommodation of the
to the monofocal controls (Figure 7). This confirms the Lumina eyes were restored almost immediately.
accommodative effect of the Lumina in a continuous range In summary, this study shows that the Lumina IOL
of distances from far to intermediate and near viewing effectively restores visual performance at near, intermedi-
distances. The Lumina defocus curve reveals a higher ate, and far distances without affecting contrast sensi-
near visual acuity compared to the monofocal IOL in tivity. Accommodation by the Lumina was confirmed by
the defocus range from 4.50 to 0.50 D. The defocused subjective procedures to measure accommodation, by

46 AMERICAN JOURNAL OF OPHTHALMOLOGY APRIL 2016

FIGURE 12. WAM-5500 images of an eye with the Lumina intraocular lens when stimulated by a continuously moving target. The
refraction is (Top, left) L0.70 diopters (D), (Top, right) L1.20 D, (Bottom, left) L1.90 D, (Bottom, right) L3.40 D. The infrared
light of the WAM-5500 reflects off the posterior optical element (arrow 1) and the anterior element (arrow 2) of the Lumina. These
reflections move owing to movement of the lens elements in accommodation.

defocus curves, and by objective procedures, by an autor- data on refractive and accommodative outcomes, taking
efractor. The monofocal control lens effectively restored into account potential complications, are necessary to
only visual performance at distance and contrast sensi- determine the perspectives of this new AIOL in future
tivity. Further investigations using long-term clinical clinical practice.

FUNDING/SUPPORT: THIS STUDY HAS BEEN SUPPORTED IN PART BY AKKOLENS INTERNATIONAL B.V. COMPANY. FINANCIAL
disclosures: Jorge Alio: AkkoLens International bv (Breda, The Netherlands): consultant/advisor and clinical research grant; Bloss Group (Barcelona,
Spain): lecture fees; Blue-Green (Alicante, Spain): equity owner; Carl Zeiss Meditec (Jena, Germany): consultant/advisor and clinical research grant;
Costruzione Strumenti Oftalmici (CSO) S.r.l. (Firenze, Italy): clinical research grant; Dompe (Milan, Italy): clinical research grant; Hanita Lenses
(Hanita, Israel): consultant/advisor and clinical research grant; Int. Ophth. Consultants (Alicante, Spain): equity owner; Jaypee Brothers Pub (London,
United Kingdom): patents/royalty; Mediphacos (Belo-Horizonte, Brazil): clinical research grant; Maghrabi Hospitals (Jeddah, Saudi Arabia): consultant/
advisor; Novagali (Évry, France): clinical research grant; Oculentis (Berlin, Germany): consultant/advisor and clinical research grant; Oftalcare Nutra-
vision (Valencia, Spain): equity owner; Omeros (Seattle, Washington): consultant/advisor; Presbia (Irvine, California): consultant/advisor; Santen
(Évry, France): consultant/advisor and Equity Owner, Schwind Eye-Tech-Solutions (Kleinostheim, Germany): lecture fees and clinical research grant;
Slack, Inc (Thorofare, New Jersey, Unites States): consultant/advisor; Springer Publications (Philadelphia, Pennsylvania): patents/royalty; Tekia, Inc
(Irvine, California): patents/royalty; Topcon Medical Systems (Oakland, New Jersey): consultant/advisor; Vissum-Valcasado (Madrid, Spain): equity
owner. Aleksey Simonov: AkkoLens International bv (Breda, The Netherlands): equity owner. Ana Belén Plaza-Puche: employee of Vissum-
Valcasado (Madrid, Spain). Alexander Angelov: AkkoLens International bv (Breda, The Netherlands): clinical research grant; Resbiomed (Sofia,
Bulgaria): equity owner. Yavor Angelov: AkkoLens International bv (Breda, The Netherlands): clinical research grant; Resbiomed (Sofia, Bulgaria):
employee. Willem van Lawick: AkkoLens International bv (Breda, The Netherlands): equity owner; MedScience, Capital (Amsterdam, The
Netherlands): equity owner. Michiel Rombach: AkkoLens International bv (Breda, The Netherlands): equity owner. All authors attest that they meet
the current ICMJE criteria for authorship.

VOL. 164 VISUAL PERFORMANCE OF THE LUMINA ACCOMMODATIVE IOL 47

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48 AMERICAN JOURNAL OF OPHTHALMOLOGY APRIL 2016

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