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ORIGINAL ARTICLE
Silicone-Diffractive Versus Acrylic-Refractive
Supplementary IOLs: Visual Performance and
Manual Handling
Jens Schrecker, MD; Sandra Blass, MD; Achim Langenbucher, PhD
ABSTRACT
PURPOSE: To compare visual outcome and manual
handling of additional multifocal sulcus-fixated intraocular lenses (IOLs) of different materials and lens concepts.
METHODS: Visual outcomes after implantation of a
monofocal IOL in the capsular bag followed by implantation of a sulcus-fixated multifocal IOL (MIOL) in patients
with cataract were assessed. Patients were randomly
assigned to receive either the refractive Sulcoflex 653F
(Rayner Surgical GmbH, Bamberg, Germany) (35 eyes)
or the diffractive MS 714 PB Diff (Dr. Schmidt Intraocularlinsen GmbH, St. Augustin, Germany) (33 eyes) additional MIOL. Three months postoperatively, visual acuity at far, intermediate, and near distance and contrast
sensitivity under different conditions were evaluated.
Patients with binocular implantation were asked to rate
their subjective quality of vision.
RESULTS: No complications occurred during or after
surgery. No significant differences in uncorrected and
corrected distance visual acuity at all distances were
found between groups. All eyes achieved uncorrected
visual acuity of 0.3 logMAR (20/40 Snellen) or better
at all distances. Contrast sensitivity was significantly
better in the diffractive MS 714 PB Diff group than in
the refractive Sulcoflex 653F group under all conditions.
The refractive Sulcoflex 653F group experienced more
photic phenomena (81%) than the diffractive MS 714
PB Diff group (25%), but the disturbances were scored
as mild to moderate in most cases (93%/100%). The
unfolding procedure of the acrylic Sulcoflex 653F IOL
was smoother and more controllable than that of the
silicone MS 714 PB Diff IOL.
CONCLUSIONS: Both additional MIOLs performed well
in terms of far, intermediate, and near vision and enabled patients to handle almost all areas of activity without glasses.
[J Refract Surg. 2014;30(1):41-48.]
T
he implantation of additional, sulcus-fixated multifocal intraocular lenses (MIOLs) enables either
a subsequent compensation for the lack of accommodation in already pseudophakic eyes or a simultaneous
compensation during cataract or refractive lens surgery.1-4
Advances in the field of additional, sulcus-fixated IOLs offer
new opportunities in correcting refractive errors or satisfying
the patient’s wish for reading without glasses.1,2 Results
achieved in previous studies have been promising.3-7
Two types of sulcus-fixated MIOLs have recently become
available on the market: the Sulcoflex 653F lens from Rayner
Surgical GmbH (Bamberg, Germany) is a one-piece acrylic
IOL based on the refractive principle and the MS 714 PB
Diff lens (Dr. Schmidt Intraocularlinsen GmbH, St. Augustin,
Germany) is a three-piece silicone IOL with a diffractive optic. Due to their different materials, designs, and optical principles, both lens types may have inherent advantages and
disadvantages.
In this study, we compared the optical performance and
the manual handling of both MIOL models.
PATIENTS AND METHODS
This prospective, randomized, monocentric clinical case
series included 68 eyes of 40 patients. Standard cataract surgery was performed and an acrylic monofocal IOL (MC 6125
AS; Dr. Schmidt Intraocularlinsen GmbH) was implanted
into the capsular bag, followed immediately by implantation
of an additional MIOL into the sulcus ciliaris. Patients were
randomly assigned to receive either the Rayner Sulcoflex
Multifocal 653F (refractive Sulcoflex 653F group; 35 eyes, 19
From the Department of Ophthalmology, Rudolf-Virchow-Klinikum
Glauchau, Glauchau, Germany (JS, SB); and the Department of Experimental
Ophthalmology, Saarland University, Homburg/Saar, Germany (AL).
Submitted: April 11, 2013; Accepted: August 20, 2013; Posted online: January
10, 2014
The authors have no financial or proprietary interest in the materials presented herein.
Correspondence: Jens Schrecker, MD, Department of Ophthalmology, RudolfVirchow-Klinikum Glauchau, Virchowstraße 18, 08371 Glauchau, Germany.
E-mail: [email protected]
doi:10.3928/1081597X-20131217-05
Journal of Refractive Surgery • Vol. 30, No. 1, 2014
41
Silicone-Diffractive vs Acrylic-Refractive Supplementary IOLs/Schrecker et al
Figure 1. (Left) Rayner Sulcoflex 653F MIOL and (right) Dr. Schmidt MS
714 PB Diff MIOL. (Photos courtesy of Rayner Surgical GmbH, Bamberg
and Dr. Schmidt Intraocularlinsen GmbH, Erlangen)
patients) or the Dr. Schmidt MS 714 PB Diff (diffractive MS 714 PB Diff group; 33 eyes, 21 patients).
Inclusion criteria were age between 40 and 80 years,
a supposed postoperative visual acuity of 0.30 logMAR
(20/40 Snellen) or better, an anterior corneal astigmatism of less than 1.0 diopter (D), and the willingness
and sufficient cognitive awareness to comply with the
examinations. Patients with previous ocular surgery or
any other eye disorder, apart from cataract, that might
significantly impair vision were not enrolled.
All surgical and study procedures followed the tenets of the Declaration of Helsinki. The study protocol
was approved by the local ethics committee and all patients gave written informed consent.
IOL Characteristics and Surgical Technique
All patients first received the monofocal MC 6125
AS posterior chamber IOL, which is a one-piece lens
made of hydrophilic acrylic with a biconvex optic design and an aspheric (aberration-neutral) anterior and
spherical posterior surface with a 360° sharp squareedge. The overall diameter of the lens is 12.5 mm and
the diameter of the lens optics is 6.0 mm.
The additional MIOL implanted in the refractive Sulcoflex 653F group (Figure 1) is a one-piece lens made of
hydrophilic acrylic with a convex-concave optic design
and an anterior haptic angulation of 10°. The lens has
a multi-zoned refractive anterior optic surface (aspheric
design) with five annular areas that alternately provide
far and near vision. The odd zones 1, 3, and 5 offer distance vision and the even zones 2 and 4 offer near vision with an additional refractive power of +3.5 D at IOL
plane. Depending on pupil size, the typical light distribution of the MIOL is 60% for distance and 40% for near
vision. The overall diameter of the lens is 14.0 mm and
the diameter of the lens optics measures 6.5 mm.
42
The additional MIOL implanted in the diffractive
MS 714 PB Diff group (Figure 1) is a three-piece IOL
made of silicone elastomer with a convex-concave optic design, 10° anteriorly angulated, modified C-Loop
polymethylmethacrylate haptics. The lens uses a combined diffractive and refractive optic design. The central part (3.6 mm) of the anterior surface consists of a
phase grating, which simultaneously creates a far and
a near focus with an additional refractive power of
+3.5 D at the IOL plane. The phase grating comprises
nine concentric rings whose step height and width is
gradually reduced toward the periphery. The peripheral monofocal aspheric refractive zone supports distance vision when the pupil is dilated. The diameter of
the haptic is 14.0 and 6.5 mm of the lens optics.
The lens power for the monofocal IOL was calculated with the IOLMaster (Carl Zeiss Meditec, Jena,
Germany) using the Holladay formula. Target refraction was emmetropia with preference for slightly positive values. Only additional MIOLs with a spherical
equivalent of 0.0 D were used.
All surgeries were performed by the same surgeon (JS).
First, a standard sutureless microincision phacoemulsification and implantation of the monofocal IOL in the
capsular bag were performed. The size of the temporal
limbal incision was made in accordance to the size of
the injector system (refractive Sulcoflex 653F group: AccuJect 2.2, Medicel AG, Berneck, Switzerland; diffractive
MS 714 PB Diff group: ISH-001, Hoya Surgical Optics,
Frankfurt/Main, Germany) used for the additional lens
inserted afterward. The incision measured 2.5 mm in the
refractive Sulcoflex 653F group and 2.8 mm in the diffractive MS 714 PB Diff group to enable the insertion of
the injector into the anterior chamber. After filling the ciliary sulcus with a viscoelastic (Healon; Abbott Medical
Optics, Santa Ana, CA), the leading haptic of the additional MIOL was inserted into the sulcus and the second
haptic was positioned by a rotary motion with the help of
an iris hook. Using irrigation and aspiration, viscoelastic
material was first removed between the lenses and subsequently from the area in front of the additional MIOL.
To prevent the potential risk of an iris capture in patients
with very large pupils, a myotic (Miochol-E; Novartis
Pharma Stein AG, Stein, Switzerland) was administered
to narrow the pupil until the iris had covered the edge of
the implant. After surgery, patients were routinely treated with local steroids and antibiotics.
Clinical Examinations and Outcome Measures
The preoperative examinations included subjective
refraction, corrected distance visual acuity (CDVA),
assessment of the anterior and posterior eye segment,
keratometry, biometry (IOLMaster and Pentacam;
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Silicone-Diffractive vs Acrylic-Refractive Supplementary IOLs/Schrecker et al
Oculus Optikgeräte GmbH, Wetzlar, Germany), intraocular pressure, and pupil size measurements.
Three months postoperatively, all patients had a
complete reexamination. Corneal surface measurements were performed with the Pentacam to assess
potential changes in corneal astigmatism, which was
defined as the absolute value of the difference between the simulated keratometric (K) values. Visual
acuity measurements included uncorrected and corrected distance distance (UDVA, CDVA), Uncorrected
and distance corrected intermediate (UIVA, DCIVA),
and uncorrected and distance corrected near (UNVA,
DCNVA) visual acuity. Distance visual acuity was
measured with optotypes according to DIN EN ISO
8596 at a distance of 5 m. Intermediate visual acuity
was measured at 1 m with the Logarithmic Visual Acuity Chart “EDTRS” 2000. Measurement of near visual
acuity was performed using Radner reading charts at
a distance of 40 cm. Binocular visual acuity measurements at all distances were performed only in patients
who had bilateral implantation of the studied lenses.
Based on the CDVA, monocular defocus curves
were obtained by measuring visual acuity with a subsequent defocus from +2.00 to -5.00 D in 0.5-D steps of
spectacle defocus.
Monocular functional acuity contrast test (F.A.C.T.)
with and without glare was performed using the Contrast Sensitivity Tester 1800 (CST 1800; Vision Sciences Research Corporation, San Ramon, CA) at two
different luminance levels (85 cd/m²: ‘high photopic’
and 6 cd/m²: ‘low photopic’).
Pupil diameter was measured with a Goldmann
Perimeter (Carl Zeiss) under high and low photopic
conditions (100 and 6 cd/m², respectively). The ambient luminance was checked with a luxmeter (Voltcraft
MS-1500; Conrad Electronic SE, Hirschau, Germany).
To assess overall patient satisfaction, subjective quality of vision, and the incidence of photic
phenomena, patients with bilateral MIOL implantation
completed a subjective questionnaire 3 months after
the second eye underwent surgery. Participants who
were enrolled with only one eye because of an already
existing monolateral pseudophakia with a multifocal
optic or because the non-study eye did not fulfill inclusion criteria were excluded from this survey. The used
questionnaire was set up according to the requirements
of the DIN EN ISO 11979-9 (MIOLs) following the Cataract TyPE Spec of Javitt et al.8 Some changes were made
in the questions about impairment in daily life to comply with common activities of older people in Germany.
Patients were asked to rate the quality of vision
without glasses for distance and near under different
lighting conditions (scoring options: very satisfied,
Journal of Refractive Surgery • Vol. 30, No. 1, 2014
TABLE 1
Preoperative Patient Demographics
Characteristic
Sulcoflex 653F
MS 714 PB Diff
P
Eyes (n)
35
33
–
Patients (n)
19
21
–
Age (y)
Median
Mean ± SD
Min/max
.246a
70
72
69.46 ± 7.06
71.39 ± 4.04
47/80
57/78
Gender
.029b,c
Male
9
17
Female
26
16
CDVA (logMAR)
Median
(Snellen)
Mean ± SD
Min/max
(Snellen)
.033a,c
0.20
(20/32)
0.22 ± 0.21
0.80/0.00
(20/125 / 20/20)
0.30
(20/40)
0.31 ± 0.21
0.80/0.00
(20/125 / 20/20)
Pupil size (mm)
High photopic
Median
Mean ± SD
Min/max
.006a,c
3.00
3.00
2.89 ± 0.50
3.17 ± 0.44
2.00/4.00
2.00/4.00
Low photopic
Median
Mean ± SD
Min/max
.133a
4.00
4.20
3.98 ± 0.85
4.26 ± 0.65
2.50/5.00
3.00/6.00
Corneal astigmatism (D)
Median
Mean ± SD
Min/max
.277a
0.62
0.58
0.61 ± 0.22
0.55 ± 0.24
0.24/0.94
0.10/0.99
IOP (mm Hg)
Median
Mean ± SD
Min/max
.228a
16
15
16.00 ± 2.06
15.30 ± 2.31
13/21
10/21
SD = standard deviation; min = minimum; max = maximum; CDVA = corrected distance visual acuity; D = diopters; IOP = intraocular pressure
a
Mann–Whitney U test.
b
Chi-square test of independence.
c
Statistically significant at P < .05.
The Sulcoflex 653F multifocal intraocular lens is manufactured by Rayner
Surgical GmbH, Bamberg, Germany, and the MS 714 PB Diff multifocal
intraocular lens is manufactured by Dr. Schmidt Intraocularlinsen GmbH, St.
Augustin, Germany.
satisfied, average, dissatisfied, very dissatisfied). They
also indicated whether any kind of photic phenomena had been present (response options: glare, halos,
blurry vision, optical distortion, none), the level of
43
Silicone-Diffractive vs Acrylic-Refractive Supplementary IOLs/Schrecker et al
A
B
Figure 2. (A) Mean monocular UDVA/CDVA of both groups 3 months postoperatively. Patients implanted binocularly: n = 16 in the refractive Sulcoflex 653F
group (group A) and n = 12 in the diffractive MS 714 PB Diff group (group B). (B) Mean binocular UDVA/CDVA of both groups 3 months postoperatively.
Patients implanted binocularly: n = 16 in the refractive Sulcoflex 653F group and n = 12 in the diffractive MS 714 PB Diff group. UDVA/CDVA = uncorrected/
corrected distance visual acuity; UIVA/DCIVA = uncorrected/distance corrected intermediate visual acuity; UNVA/DCNVA = uncorrected/distance corrected
near visual acuity; ° = outlier (between 1.5 and 3.0 interquartile ranges below the first quartile and above the third quartile); * = extreme value (more than
3.0 interquartile ranges below the first quartile and above the third quartile)
disturbances (scoring options: minimal, mild, moderate, moderately severe, severe), and how fast they
had adapted to them (scoring options: very quickly,
quickly, slowly, not yet). Patients were also asked to
state whether they would choose the same IOL again
(response options: yes, possibly, no).
Statistical Analysis
Statistical analysis was performed with the IBM SPSS
version 20 (SPSS, Inc., Chicago, IL). Distance, intermediate, and near visual acuities were converted from
decimal units into the logMAR scale for further analysis.
Variables were described by mean, standard deviation,
median, minimum, and maximum. To test differences
between the two groups, the non-parametric Mann–
Whitney U test for unpaired samples was performed.
Differences related to gender were tested using the chisquare test of independence. Intergroup differences were
checked with the paired Wilcoxon test. A P value of less
than .05 was considered statistically significant.
RESULTS
Thirty-five eyes of 19 patients received the Sulcoflex
653F IOL (refractive Sulcoflex 653F group) and 33 eyes of
21 patients received the MS 714 PB Diff IOL (diffractive
MS 714 PB Diff group). Sixteen patients in the refractive
Sulcoflex 653F group and 12 patients in the diffractive
MS 714 PB Diff group had bilateral implantation.
Table 1 shows the patient demographics and the
comparison of preoperative data of the study cohorts.
44
The postoperative course was uneventful in all cases.
All lenses were symmetrically fixed in the capsular bag
and sulcus with no noticeable decentration or tilt. No explantations or exchanges of IOL were required. Due to
the properties of the silicone material, the MS 714 PB
Diff IOL unfolded relatively fast during implantation
and required a sizeable clockwise rotation of the injector
while unfolding. The unfolding procedure of the acrylic
Sulcoflex 653F IOL was smoother and more controllable.
Mild pigment dispersion with no need of treatment was
observed in 6 eyes in the refractive Sulcoflex 653F group
and 2 eyes in the diffractive MS 714 PB Diff group.
Three months postoperatively, the median corneal
astigmatism was 0.50 D (range: 0.10 to 1.30 D) in the refractive Sulcoflex 653F group and 0.70 D (range: 0.30 to
1.40 D) in the diffractive MS 714 PB Diff group. The median surgically induced astigmatism was 0.32 D (range:
0.04 D to 1.07 D) and 0.41 D (range: 0.10 D to 2.10 D)
in the refractive Sulcoflex 653F and diffractive MS 714
PB Diff groups (P = .031), respectively. The mean pupil size under high photopic conditions was 2.95 mm
in the refractive Sulcoflex 653F group and 3.19 mm in
the diffractive MS 714 PB Diff group (P = .006, Mann–
Whitney U test). The mean pupil size under low photopic conditions was 4.06 mm in the refractive Sulcoflex
653F group and 4.15 mm in the diffractive MS 714 PB
Diff group (P = .133, Mann–Whitney U test). The median refractive error from target refraction was -0.11 D
(range: -0.32 to 0.57 D) in the refractive Sulcoflex 653F
group and -0.10 D (range: -0.37 to 0.50 D) in the diffracCopyright © SLACK Incorporated
Silicone-Diffractive vs Acrylic-Refractive Supplementary IOLs/Schrecker et al
Figure 3. Percentage of eyes at given visual
acuity levels for uncorrected monocular
visual acuity at distance (5 m), intermediate
(1 m), and near (40 cm) in the refractive
Sulcoflex 653F group (blue) and diffractive
MS 714 PB Diff group (brown) 3 months
postoperatively.
A
C
B
D
Figure 4. Monocular contrast sensitivity of the refractive Sulcoflex 653F group (blue) and diffractive MS 714 PB Diff group (brown) under high (85 cd/m2)
photopic conditions (A) without and (B) with glare and under low (6 cd/m2) photopic conditions (C) without and (D) with glare 3 months postoperatively.
The grey areas show the standard function of contrast sensitivity. Asterisks indicate statistically significant differences (P < .05, Mann–Whitney U test).
CPD = cycles per degree
tive MS 714 PB Diff group, with no statistical difference
between groups (P = .985, Mann–Whitney U test).
Results of the monocular and binocular measurements of visual acuity at all tested distances are shown
in Figure 2. No statistical differences were found
between the groups. All eyes achieved uncorrected
Journal of Refractive Surgery • Vol. 30, No. 1, 2014
visual acuity of 0.3 logMAR (20/40 Snellen) or better
at all distances (Figure 3).
Contrast sensitivity test results under high (85 cd/
m2) and low (6 cd/m2) photopic conditions, with and
without glare, are shown in Figure 4. Under high photopic conditions, the diffractive MS 714 PB Diff group
45
Silicone-Diffractive vs Acrylic-Refractive Supplementary IOLs/Schrecker et al
Figure 5. Median monocular defocus curves of the refractive Sulcoflex
653F group (group A) (blue) and diffractive MS 714 PB Diff group (group B)
(brown) 3 months postoperatively. The whiskers represent the interquartile
range. Asterisks indicate statistically significant differences (P < .05, Mann–
Whitney U test).
Figure 7. Percentage of photic phenomena experienced by patients
who had binocular multifocal intraocular lens implantation. group A =
Sulcoflex 653F lens; group B = MS 714 PB Diff lens
performed significantly better than the refractive Sulcoflex 653F group at spatial frequencies of 6 cycles per
degree [CPD] and more without glare, and at all spatial
frequencies with glare (Figures 4A-4B). Low photopic
contrast sensitivity measurement showed significantly
better contrast sensitivity outcomes for the diffractive
MS 714 PB Diff group at spatial frequencies of 6 CPD
and higher without glare and at spatial frequencies of
6 and 12 CPD with glare (Figures 4C-4D).
The defocus curves of both groups (Figure 5) showed
similar visual acuity at the vergences that correspond
to distance and near vision. Statistically significant
differences were found in the medium area and in the
left and right outer areas, where the eyes in the diffractive MS 714 PB Diff group performed better. In the
medium area, eyes of both groups obtained a median
visual acuity of 0.40 logMAR (20/50 Snellen) or better.
The questionnaire was evaluated in patients who
had bilateral implantation (refractive Sulcoflex 653F
group: n = 16; diffractive MS 714 PB Diff group: n =
12). Three eyes of 3 patients had corneal astigmatism
greater than 1.0 D or a capsular tension ring was required intraoperatively. One patient unfortunately
died before finishing the follow-up of the fellow eye.
The results concerning subjective quality of distance
46
Figure 6. Rating of quality of vision without glasses for distance and near
under different lighting conditions 3 months postoperatively. group A =
Sulcoflex 653F lens; group B = MS 714 PB Diff lens
and near vision under different lighting conditions are
shown in Figure 6. In the diffractive MS 714 PB Diff
group, 75% of patients did not experience visual disturbances at night, such as glare and halos, compared
to 19% in the refractive Sulcoflex 653F group (Figure
7). Among patients who reported these phenomena,
halos were predominant (50% in the refractive Sulcoflex 653F group; 17% in the diffractive MS 714 PB Diff
group). Visual disturbances were described as minimal
to mild in 36% and 33%, moderate in 57% and 67%,
and moderately severe in 7% and 0% in the refractive
Sulcoflex 653F and diffractive MS 714 PB Diff groups,
respectively. None of the patients was severely disturbed by photic phenomena.
In the refractive Sulcoflex 653F group, 57% adapted
slowly to visual disturbances, 14% adapted quickly,
and 29% adapted very quickly. Two patients in the
diffractive MS 714 PB Diff group said they adapted
very quickly, but another reported not having adapted
during follow-up and would not choose the same IOL
again. All other patients of both groups would decide
in favor of their IOLs again.
DISCUSSION
The basic optical properties of refractive and diffractive MIOLs have already been described in detail.9,10 With diffractive MIOLs, the ratio of light energy
provided for near and far focus is not affected by pupil
size in contrast to refractive MIOLs, which depend on
pupil size.11-13 In this study, the mean pupil size under high photopic conditions (100 cd/m2) was significantly smaller in the refractive Sulcoflex 653F group
(2.89 ± 0.50 mm) than in the diffractive MS 714 PB
Diff group (3.17 ± 0.44 mm) (P = .006, Mann–Whitney
U test). Indeed, corneal astigmatism was significantly
higher in the diffractive MS 714 PB Diff group (P =
.01, Mann–Whitney U test) as a result of the higher
incision size and a corresponding higher surgically
induced astigmatism in this group, but the difference
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Silicone-Diffractive vs Acrylic-Refractive Supplementary IOLs/Schrecker et al
between the groups was only 0.20 D. We found no correlation between corneal astigmatism/pupil size and
visual acuity.
No significant difference in mean UCVA and CDVA
at all tested distances was found between the groups. Visual outcomes were good, with all eyes achieving UCVA
of 0.3 logMAR (20/40 Snellen) or better at all distances.
More precisely, the percentage of eyes reaching UDVA/
UIVA (1 m) of 0.1 logMAR (20/25 Snellen) or better
was achieved by 94%/89% of the eyes in the refractive
Sulcoflex 653F group and 97%/97% of the eyes in the
diffractive MS 714 PB Diff group, respectively. Regarding near vision, the percentage of eyes achieving UNVA
of 20/25 was higher in the diffractive MS 714 PB Diff
group (88%) than in the refractive Sulcoflex 653F group
(66%). These data are consistent with those reported
in previous studies in which diffractive and refractive
MIOLs were compared. For example, the AcrySof ReSTOR, which combines a diffractive and refractive design, performed similarly to the refractive ReZoom in
terms of near and far vision.14 In another comparative
study by Cilino et al.,15 mean distance and intermediate visual acuities did not differ significantly between
the fully diffractive Tecnis ZM900, the refractive Array
SA40N, and the ReZoom. Only for mean distance corrected near visual acuity, where the diffractive MIOL
performed better, was a statistically significant difference found.15
As shown in the defocus curves, the visual acuity
at the relevant vergences is similar in both groups. In
near vision, the median visual acuity differed slightly
between the groups, but no statistically significant differences could be found at a vergence of -3.0 D.
Compared to monofocal IOLs, it is generally acknowledged that contrast sensitivity after MIOL implantation
might be reduced due to the overlap of two (or more)
foci and the reduced amount of light that creates the distance focus. In our study, mean contrast sensitivity values in both groups were within normal range under high
photopic conditions (85 cd/m2) with and without glare.
These data are in agreement with those reported with
other MIOLs in a literature review by de Vries and Nuijts.16 However, in our study the diffractive MS 714 PB
Diff group performed significantly better than refractive
Sulcoflex 653F group, particularly at spatial frequencies
of 6 CPD and higher under all lighting conditions with
and without glare. These findings correspond to a higher incidence of visual disturbances such as glare and/or
halos in the refractive Sulcoflex 653F group.
An objective of the study was bilateral multifocality
for all patients. Only bilateral implantations were included in the survey because participants had to assess their
everyday life in the survey and only the binocular visual
Journal of Refractive Surgery • Vol. 30, No. 1, 2014
impression of the examined IOL should be compared.
The subjectively experienced performance of both additional MIOLs was reflected in the answers of 16 patients
in the refractive Sulcoflex 653F group and 12 patients in
the diffractive MS 714 PB Diff group, with the majority of
them reporting to be “very satisfied” or “satisfied” with
their vision at all distances tested and under all lighting
conditions. This was despite the perceived photic phenomena that were reported by numerous patients (81%
in the refractive versus 25% in the diffractive group).
These data are similar to those reported in previous studies comparing refractive and diffractive MIOLs.16-19 However, in our study the disturbances were scored merely as
mild to moderate in most cases. In the majority of cases,
patients adapted gradually to these photic phenomena
over time (a detailed analysis of different adaptation periods was not performed in this study).
In the past, drawbacks with the so-called piggyback IOLs were mainly caused by contact of the two
biconvex lenses followed by refractive deviations or
the ingrowth of lens epithelial cells between the optics
of the IOLs. None of those problems occurred in our
study. The reason for this is the design of the modern
additional IOLs with convex-concave lens optics and
purpose-built haptics for sulcus-fixation.
In this study, only ‘one-session’ implantation was
examined. However, additional sulcus-fixated IOLs
also offer the possibility for subsequent correction of
refractive errors after primary cataract surgery and/or
the correction of pseudophakic presbyopia. Several
studies with MIOLs4-6 and other types of additional
sulcus-fixated IOLs1,2,7 have shown the efficacy and
safety of this approach.
In comparison to IOL implantation into the capsular bag, there is less space for the unfolding procedure with additional IOL. Therefore, the injectors
have to be inserted relatively deep into the anterior
chamber, which allows a safe unfolding with an adequate distance control to corneal endothelium. Due
to the different materials of the studied IOLs, we
have experienced differences in manual handling.
The Sulcoflex 653F lens unfolded markedly slower,
which provided better control during the implantation process than with the MS 714 PB Diff lens and
also resulted in a shorter learning curve. Furthermore, the acrylic lenses could be folded to a more
compact size within the IOL injector, allowing for a
smaller incision width.
Both types of supplementary MIOLs tested in this
study performed without complications during the implantation process and postoperative course. All eyes
achieved good UCVA at far, intermediate, and near
distance, resulting in high patient satisfaction.
47
Silicone-Diffractive vs Acrylic-Refractive Supplementary IOLs/Schrecker et al
AUTHOR CONTRIBUTIONS
Study concept and design (AL, JS); data collection (SB); analysis and
interpretation of data (JS); drafting of the manuscript (SB, JS); critical revision of the manuscript (AL, JS); administrative, technical, or
material support (AL); supervision (JS)
10.Davison JA, Simpson MJ. History and development of the
apodized diffractive intraocular lens. J Cataract Refract Surg.
2006;32:849-858.
REFERENCES
12. Artigas JM, Menezo JL, Peris C, Felipe A, Diaz-Llopis M. Image
quality with multifocal intraocular lenses and the effect of pupil size: comparison of refractive and hybrid refractive-diffractive designs. J Cataract Refract Surg. 2007;33:2111-2117.
2.Sauder G. Secondary toric intraocular lens implantation in
pseudophakic eyes: the add-on IOL system [article in German].
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