Silicone-Diffractive Versus Acrylic-Refractive ...

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41Journal of Refractive Surgery • Vol. 30, No. 1, 2014

O R I G I N A L A R T I C L E

he implantation of additional, sulcus-fixated mul-tifocal intraocular lenses (MIOLs) enables either a subsequent compensation for the lack of accom-

modation 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 op-tic. Due to their different materials, designs, and optical prin-ciples, 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 METHODSThis prospective, randomized, monocentric clinical case

series included 68 eyes of 40 patients. Standard cataract sur-gery 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

TABSTRACT

PURPOSE: To compare visual outcome and manual handling of additional multifocal sulcus-fixated intra-ocular lenses (IOLs) of different materials and lens con-cepts.

METHODS: Visual outcomes after implantation of a monofocal IOL in the capsular bag followed by implanta-tion 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 Intraocu-larlinsen GmbH, St. Augustin, Germany) (33 eyes) ad-ditional MIOL. Three months postoperatively, visual acu-ity 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 en-abled patients to handle almost all areas of activity with-out glasses.

[J Refract Surg. 2014;30(1):41-48.]

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 pre-sented herein.

Correspondence: Jens Schrecker, MD, Department of Ophthalmology, Rudolf-Virchow-Klinikum Glauchau, Virchowstraße 18, 08371 Glauchau, Germany. E-mail: [email protected]

doi:10.3928/1081597X-20131217-05

Silicone-Diffractive Versus Acrylic-Refractive Supplementary IOLs: Visual Performance and Manual HandlingJens Schrecker, MD; Sandra Blass, MD; Achim Langenbucher, PhD

42 Copyright © SLACK Incorporated

Silicone-Diffractive vs Acrylic-Refractive Supplementary IOLs/Schrecker et al

patients) or the Dr. Schmidt MS 714 PB Diff (diffrac-tive 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 astigma-tism 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 te-nets of the Declaration of Helsinki. The study protocol was approved by the local ethics committee and all pa-tients gave written informed consent.

IOL CharaCterIstICs and surgICaL teChnIqueAll 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 de-sign and an aspheric (aberration-neutral) anterior and spherical posterior surface with a 360° sharp square-edge. 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 Sul-coflex 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 dis-tance vision and the even zones 2 and 4 offer near vi-sion with an additional refractive power of +3.5 D at IOL plane. Depending on pupil size, the typical light distribu-tion 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.

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 op-tic design, 10° anteriorly angulated, modified C-Loop polymethylmethacrylate haptics. The lens uses a com-bined diffractive and refractive optic design. The cen-tral 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 periph-eral monofocal aspheric refractive zone supports dis-tance 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 calcu-lated with the IOLMaster (Carl Zeiss Meditec, Jena, Germany) using the Holladay formula. Target refrac-tion was emmetropia with preference for slightly posi-tive 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 phacoemulsi-fication 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: Ac-cuJect 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 dif-fractive MS 714 PB Diff group to enable the insertion of the injector into the anterior chamber. After filling the cil-iary sulcus with a viscoelastic (Healon; Abbott Medical Optics, Santa Ana, CA), the leading haptic of the addi-tional 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 sub-sequently 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 treat-ed with local steroids and antibiotics.

CLInICaL examInatIOns and OutCOme measuresThe preoperative examinations included subjective

refraction, corrected distance visual acuity (CDVA), assessment of the anterior and posterior eye segment, keratometry, biometry (IOLMaster and Pentacam;

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)



Oculus Optikgeräte GmbH, Wetzlar, Germany), intra-ocular pressure, and pupil size measurements.

Three months postoperatively, all patients had a complete reexamination. Corneal surface measure-ments were performed with the Pentacam to assess potential changes in corneal astigmatism, which was defined as the absolute value of the difference be-tween the simulated keratometric (K) values. Visual acuity measurements included uncorrected and cor-rected 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 Acu-ity Chart “EDTRS” 2000. Measurement of near visual acuity was performed using Radner reading charts at a distance of 40 cm. Binocular visual acuity measure-ments 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 sub-sequent 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 Con-trast Sensitivity Tester 1800 (CST 1800; Vision Sci-ences 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 ambi-ent luminance was checked with a luxmeter (Voltcraft MS-1500; Conrad Electronic SE, Hirschau, Germany).

To assess overall patient satisfaction, subjec-tive 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 inclu-sion 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 Cata-ract TyPE Spec of Javitt et al.8 Some changes were made in the questions about impairment in daily life to com-ply 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,

satisfied, average, dissatisfied, very dissatisfied). They also indicated whether any kind of photic phenom-ena had been present (response options: glare, halos, blurry vision, optical distortion, none), the level of

TABLE 1 Preoperative Patient Demographics

Characteristic Sulcoflex 653F MS 714 PB Diff P

Eyes (n) 35 33 –

Patients (n) 19 21 –

Age (y) .246a

Median 70 72

Mean ± SD 69.46 ± 7.06 71.39 ± 4.04

Min/max 47/80 57/78

Gender .029b,c

Male 9 17

Female 26 16

CDVA (logMAR) .033a,c

Median (Snellen)

0.20 (20/32)

0.30 (20/40)

Mean ± SD 0.22 ± 0.21 0.31 ± 0.21

Min/max (Snellen)

0.80/0.00 (20/125 / 20/20)

0.80/0.00 (20/125 / 20/20)

Pupil size (mm)

High photopic .006a,c

Median 3.00 3.00

Mean ± SD 2.89 ± 0.50 3.17 ± 0.44

Min/max 2.00/4.00 2.00/4.00

Low photopic .133a

Median 4.00 4.20

Mean ± SD 3.98 ± 0.85 4.26 ± 0.65

Min/max 2.50/5.00 3.00/6.00

Corneal astig-matism (D)

.277a

Median 0.62 0.58

Mean ± SD 0.61 ± 0.22 0.55 ± 0.24

Min/max 0.24/0.94 0.10/0.99

IOP (mm Hg) .228a

Median 16 15

Mean ± SD 16.00 ± 2.06 15.30 ± 2.31

Min/max 13/21 10/21

SD = standard deviation; min = minimum; max = maximum; CDVA = cor-rected distance visual acuity; D = diopters; IOP = intraocular pressure aMann–Whitney U test. bChi-square test of independence. cStatistically 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.



disturbances (scoring options: minimal, mild, mod-erate, 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 anaLysIsStatistical analysis was performed with the IBM SPSS

version 20 (SPSS, Inc., Chicago, IL). Distance, inter-mediate, 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 chi-square test of independence. Intergroup differences were checked with the paired Wilcoxon test. A P value of less than .05 was considered statistically significant.

RESULTSThirty-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.

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 ex-plantations 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 re-fractive Sulcoflex 653F group and 0.70 D (range: 0.30 to 1.40 D) in the diffractive MS 714 PB Diff group. The me-dian 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 pu-pil 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 phot-opic 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 me-dian 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 diffrac-

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)

A B



tive MS 714 PB Diff group, with no statistical difference between groups (P = .985, Mann–Whitney U test).

Results of the monocular and binocular measure-ments of visual acuity at all tested distances are shown in Figure 2. No statistical differences were found between the groups. All eyes achieved uncorrected

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 phot-opic conditions, the diffractive MS 714 PB Diff group

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.

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

A

C

B

D



performed significantly better than the refractive Sul-coflex 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 dif-fractive 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 re-quired intraoperatively. One patient unfortunately died before finishing the follow-up of the fellow eye. The results concerning subjective quality of distance

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 dis-turbances 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 Sulco-flex 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 dis-turbed 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.

DISCUSSIONThe basic optical properties of refractive and dif-

fractive MIOLs have already been described in de-tail.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 un-der high photopic conditions (100 cd/m2) was signifi-cantly 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

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 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

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



between the groups was only 0.20 D. We found no cor-relation 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. Vi-sual 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. Regard-ing 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 Re-STOR, which combines a diffractive and refractive de-sign, 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 intermedi-ate visual acuities did not differ significantly between the fully diffractive Tecnis ZM900, the refractive Array SA40N, and the ReZoom. Only for mean distance cor-rected near visual acuity, where the diffractive MIOL performed better, was a statistically significant differ-ence 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 dif-ferences could be found at a vergence of -3.0 D.

Compared to monofocal IOLs, it is generally acknowl-edged 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 dis-tance focus. In our study, mean contrast sensitivity val-ues 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 Nui-jts.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 high-er 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 includ-ed in the survey because participants had to assess their everyday life in the survey and only the binocular visual

impression of the examined IOL should be compared. The subjectively experienced performance of both addi-tional 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 phe-nomena 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 stud-ies comparing refractive and diffractive MIOLs.16-19 How-ever, 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 pe-riods was not performed in this study).

In the past, drawbacks with the so-called piggy-back 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 cap-sular bag, there is less space for the unfolding pro-cedure with additional IOL. Therefore, the injectors have to be inserted relatively deep into the anterior chamber, which allows a safe unfolding with an ad-equate 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 implanta-tion process than with the MS 714 PB Diff lens and also resulted in a shorter learning curve. Further-more, 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 im-plantation process and postoperative course. All eyes achieved good UCVA at far, intermediate, and near distance, resulting in high patient satisfaction.



AUTHOR CONTRIBUTIONSStudy concept and design (AL, JS); data collection (SB); analysis and

interpretation of data (JS); drafting of the manuscript (SB, JS); criti-

cal revision of the manuscript (AL, JS); administrative, technical, or

material support (AL); supervision (JS)

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