7
222 Copyright © SLACK Incorporated ORIGINAL ARTICLE t has been demonstrated that higher order aberrations (HOAs) increase after laser refractive surgery. 1-4 The most commonly affected aberration is the spherical ab- erration, which increases positively after myopic laser sur- gery and negatively after laser correction for hyperopia. 1-4 It is crucial to know the type of aberrations induced by cur- rently available presbyopia-correcting IOLs for evaluating whether their implantation is recommendable in eyes with previous laser refractive surgery that are already aberrated. From a clinical perspective, the outcomes of the implanta- tion of presbyopia-correcting IOLs, including different types of multifocal IOLs, in eyes with previous refractive surgery have been evaluated. 5-7 However, as far as we know, studies of the effect of these IOLs on the aberrations of an eye with previous refractive surgery has not been performed, either clinically or in vitro. The possibility of knowing the aberro- metric induction of any presbyopia-correcting IOL before its implantation is a valuable tool to predict the consequences on the patients’ visual quality of such implantation and to define and optimize selection of the IOL to implant. In a previous study, the “in vitro” aberrometric pattern of a refractive IOL and two extended depth of focus IOLs were an- alyzed. 8 Three multifocal IOLs were analyzed in virgin eyes: Lentis Mplus X LS-313 MF30 (Oculentis GmbH, Berlin, Ger- many), TECNIS Symfony ZXR00 (Johnson & Johnson Vision, Santa Ana, CA), and Mini Well (SIFI S.p.A., Lavinaio, Italy). Three different pupil sizes were used for the comparison (3, 4, and 4.7 mm). In that study, it was concluded that the Mini Well IOL induced negative primary and positive secondary I ABSTRACT PURPOSE: To simulate the optical performance of three presbyopia-correcting intraocular lenses (IOLs) implant- ed in eyes with previous laser refractive surgery. METHODS: A simulation of the through-focus modu- lation transfer function (MTF) was performed for three presbyopia-correcting IOLs (Mplus, Oculentis GmbH, Berlin, Germany; Symfony, Johnson & Johnson Vision, Santa Ana, CA; and Mini Well, SIFI S.p.A., Lavinaio, It- aly) in one eye with previous myopic LASIK and another with hyperopic LASIK. Real topographic data and the wavefront aberration profile of each IOL obtained with a Hartmann–Shack sensor were used. RESULTS: In the eye with myopic LASIK, all IOLs lost optical quality at near and intermediate distances for 4- and 4.7-mm pupil size. For 3-mm pupil size, the Mini Well IOL showed the best intermediate and near MTF and maintained the far focus independently of the pu- pil. In the eye with hyperopic LASIK, the Mini Well IOL showed an intermediate, distance, and -4.00-diopter (D) foci for all pupils. The Symfony IOL showed a depth of focus at far and intermediate distance for 3-mm and a focus at -2.50 D in the rest. The Mplus showed a focus of -4.50 and -3.00 D for the 3- and 4-mm pupil, respectively. CONCLUSIONS: The Mini Well and Symfony IOLs seem to work better than the Mplus IOL in eyes with previous myopic LASIK. With previous hyperopic LASIK, the Mini Well IOL seems to be able to provide acceptable near, intermediate, and far foci for all pupil sizes. These find- ings should be confirmed in future clinical studies. [J Refract Surg. 2018;34(4):222-227.] From Grupo de Óptica y Percepción Visual, Department of Optics, Pharmacology and Anatomy, University of Alicante, Alicante, Spain. Submitted: July 3, 2017; Accepted: December 20, 2017 The authors have no financial or proprietary interest in the materials pre- sented herein. Correspondence: Vicente J. Camps, PhD, Departamento de Óptica, Farmacología y Anatomía, Universidad de Alicante, Crta San Vicente del Raspeig s/n, 03690 San Vicente del Raspeig, Alicante, Spain. E-mail: vicente. [email protected] doi:10.3928/1081597X-20180130-02 Simulation of the Effect of Different Presbyopia-Correcting Intraocular Lenses With Eyes With Previous Laser Refractive Surgery Vicente J. Camps, PhD; Juan J. Miret, PhD; Celia García, PhD; Angel Tolosa, MSc; David P. Piñero, PhD

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222 Copyright © SLACK Incorporated

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

t has been demonstrated that higher order aberrations (HOAs) increase after laser refractive surgery.1-4 The most commonly affected aberration is the spherical ab-

erration, which increases positively after myopic laser sur-gery and negatively after laser correction for hyperopia.1-4 It is crucial to know the type of aberrations induced by cur-rently available presbyopia-correcting IOLs for evaluating whether their implantation is recommendable in eyes with previous laser refractive surgery that are already aberrated. From a clinical perspective, the outcomes of the implanta-tion of presbyopia-correcting IOLs, including different types of multifocal IOLs, in eyes with previous refractive surgery have been evaluated.5-7 However, as far as we know, studies of the effect of these IOLs on the aberrations of an eye with previous refractive surgery has not been performed, either clinically or in vitro. The possibility of knowing the aberro-metric induction of any presbyopia-correcting IOL before its implantation is a valuable tool to predict the consequences on the patients’ visual quality of such implantation and to define and optimize selection of the IOL to implant.

In a previous study, the “in vitro” aberrometric pattern of a refractive IOL and two extended depth of focus IOLs were an-alyzed.8 Three multifocal IOLs were analyzed in virgin eyes: Lentis Mplus X LS-313 MF30 (Oculentis GmbH, Berlin, Ger-many), TECNIS Symfony ZXR00 (Johnson & Johnson Vision, Santa Ana, CA), and Mini Well (SIFI S.p.A., Lavinaio, Italy). Three different pupil sizes were used for the comparison (3, 4, and 4.7 mm). In that study, it was concluded that the Mini Well IOL induced negative primary and positive secondary

IABSTRACT

PURPOSE: To simulate the optical performance of three presbyopia-correcting intraocular lenses (IOLs) implant-ed in eyes with previous laser refractive surgery.

METHODS: A simulation of the through-focus modu-lation transfer function (MTF) was performed for three presbyopia-correcting IOLs (Mplus, Oculentis GmbH, Berlin, Germany; Symfony, Johnson & Johnson Vision, Santa Ana, CA; and Mini Well, SIFI S.p.A., Lavinaio, It-aly) in one eye with previous myopic LASIK and another with hyperopic LASIK. Real topographic data and the wavefront aberration profile of each IOL obtained with a Hartmann–Shack sensor were used.

RESULTS: In the eye with myopic LASIK, all IOLs lost optical quality at near and intermediate distances for 4- and 4.7-mm pupil size. For 3-mm pupil size, the Mini Well IOL showed the best intermediate and near MTF and maintained the far focus independently of the pu-pil. In the eye with hyperopic LASIK, the Mini Well IOL showed an intermediate, distance, and -4.00-diopter (D) foci for all pupils. The Symfony IOL showed a depth of focus at far and intermediate distance for 3-mm and a focus at -2.50 D in the rest. The Mplus showed a focus of -4.50 and -3.00 D for the 3- and 4-mm pupil, respectively.

CONCLUSIONS: The Mini Well and Symfony IOLs seem to work better than the Mplus IOL in eyes with previous myopic LASIK. With previous hyperopic LASIK, the Mini Well IOL seems to be able to provide acceptable near, intermediate, and far foci for all pupil sizes. These find-ings should be confirmed in future clinical studies.

[J Refract Surg. 2018;34(4):222-227.]From Grupo de Óptica y Percepción Visual, Department of Optics, Pharmacology and Anatomy, University of Alicante, Alicante, Spain.

Submitted: July 3, 2017; Accepted: December 20, 2017

The authors have no financial or proprietary interest in the materials pre-sented herein.

Correspondence: Vicente J. Camps, PhD, Departamento de Óptica, Farmacología y Anatomía, Universidad de Alicante, Crta San Vicente del Raspeig s/n, 03690 San Vicente del Raspeig, Alicante, Spain. E-mail: [email protected]

doi:10.3928/1081597X-20180130-02

Simulation of the Effect of Different Presbyopia-Correcting Intraocular Lenses With Eyes With Previous Laser Refractive SurgeryVicente J. Camps, PhD; Juan J. Miret, PhD; Celia García, PhD; Angel Tolosa, MSc; David P. Piñero, PhD

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spherical aberrations for all pupil sizes. The Symfony IOL aberrations seemed to be pupil dependent, not producing negative primary spherical aberration for 3 mm but increasing for larger pupils. Meanwhile, the HOAs for the Mini Well and Symfony IOLs were not significant for all sizes. The Mplus IOL showed in all cases the highest HOAs and became clinically relevant for pupils larger than 4 mm.

The aim of the current investigation was to propose a technique to simulate the optical performance of three presbyopia-correcting IOLs implanted in eyes with previous myopic or hyperopic laser refractive surgery. This methodology combines in vitro IOL wavefront aberration measurement, the use of real corneal topo-graphic data, and ray-tracing simulation.

PATIENTS AND METHODSDescription of ioLs MeasureD

The Mini Well IOL is a progressive extended depth-of-focus (EDOF) IOL, with an equivalent addition of +3.00 diopters (D). It has a patented optical design based on the application of positive and negative spherical aberration in the central part of the IOL to increase the depth of focus. The optic is divided into three different annular zones: the inner and middle zones have different spherical aberrations with oppo-site signs, whereas the outer zone is monofocal aspher-ical. The IOL overall diameter is 10.75 mm, its optical surface diameter is 6 mm, and it includes an ultravio-let filter. Furthermore, the dioptric spectrum that is commercially available ranges from 0.00 to +30.00 D. In our in vitro study, we used an IOL with 20.00 D of optical power.

The Symfony IOL is a biconvex and pupil-independent diffractive IOL, which combines an achromatic diffractive surface with an echelette design. Its overall diameter is 13 mm and its optical zone diameter is 6 mm. The power spectrum available ranges from +5.00 to +34.00 D, and in-corporates an ultraviolet light-absorbing filter. We used an IOL of 20.00 D with an addition of +4.00 D for the current study.

The Mplus IOL is a refractive bifocal IOL composed of an aspheric distance vision zone combined with a posterior sector-shaped near vision zone allowing seamless varifocal transition between the zones. The IOL overall diameter is 11 mm and its optical zone di-ameter is 6 mm. The power spectrum available ranges from -10.00 to +36.00 D. In our study, we used an IOL with a power of 20.00 D and an addition of 3.00 D.

MeasureMent siMuLation set-upFollowing the guidelines established by the

ISO11979-9,9 the in vitro optical quality of an IOL can

be evaluated by measuring the through-focus modu-lation transfer function (MTF) for a spatial frequency of 50 cycles/mm (MTF values for different levels of vergence) using an aberration-free eye model, where the studied IOL is inserted. The curves obtained for a spatial frequency of 50 cycles/mm approximates the visual function assessment with an optotype for 0.50 decimal visual acuity (20/40 Snellen).

In the current study, the theoretical through-focus MTF of each specific IOL was evaluated in eyes with previous laser refractive surgery. Specifically, simula-tions were conducted in two eyes, one with previous myopic LASIK and another with previous hyperopic LASIK. The simulations were made according to the following steps:

1. The wavefront profile of each IOL was character-ized using a Hartmann–Shack wavefront sensor while the IOL was placed in a liquid medium con-tained between two flat windows.8 Once character-ized, the phase transformation introduced by each IOL was calculated.

2. An eye model was built using the OpTaliX software (Optenso Optical Engineering Software, Heerbrug, Switzerland).10 The topographic data of the two eyes used for the simulations was uploaded and ex-ported in .csv format from the Sirius system (CSO, Firenze, Italy),11 whose repeatability in patients with previous refractive surgery has already been demonstrated.12

3. The IOL was introduced as a phase element in the eye model and the through-focus MTF for each IOL was simulated by ray tracing.

It has been suggested that Hartmann–Shack type wavefront sensors may bias some aberrometric mea-surements obtained with some diffractive IOLs due to a split of lenslet spots produced by more than one diffractive zone within the same lenslet.13,14 In our study, the only diffractive IOL evaluated was the Symfony, which had diffractive zones that were large enough (only 10 diffractive zones) to be resolved by our Hartmann–Shack configuration based on the use of a lenslet pitch of 150 µm and a low wavelength of 532 nm.13,14 In our measurements with the diffractive IOL mentioned, only some isolated spots were not well defined due to the registration of the wavefront using information coming from a diffractive transi-tion zone.

Ray tracing has been employed to determine the optimal IOL power after laser surgery.15,16 The main drawback of these studies is that real IOL data (radius of curvature of its surfaces, thickness, and refractive

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Presbyopia-Correcting IOL Simulation/Camps et al

index) are required. In most cases, this type of data is not accessible or even patent protected. As we men-tioned above, we have circumvented this situation by measuring the phase transformation that the IOL in-duces and implementing it in our simulated eye mod-el that uses real topographic data. All measurements were performed for three exit pupil sizes (3-, 4-, and 4.7-mm diameter).

cLinicaL DataThe topographic data of two eyes were used for the

ray-tracing simulations conducted in the current study (Figure A, available in the online version of this article). The first case of myopic LASIK was a 37-year-old man with a manifest refraction of -8.00 -0.25 × 115°, cor-rected distance visual acuity (CDVA) of 0.00 logMAR (20/20 Snellen), and a scotopic pupil diameter of 5 mm. The second case of hyperopic LASIK was a 38-year-old man with a manifest refraction of +3.75 -0.50 × 95°, CDVA of 0.00 logMAR (20/20 Snellen), and a scotopic pupil diameter of 5 mm. Both eyes were treated with

LASIK using the Pulzar Z1 solid-state laser platform (CustomVis Laser Pty Ltd, Osborne Park, Australia, cur-rently CV Laser Pty Ltd) and an automated mechanical microkeratome (M2; Moria, Antony, France), creating a 110-µm thickness flap with superior hinge and 9- to 9.5-mm diameter at the Department of Ophthalmology (Oftalmar) of Vithas Medimar International Hospital (Alicante, Spain).

RESULTSThe through-focus MTFs for all IOLs and the three

pupil sizes are shown in Figures 1-2. These figures are presented with the same scale for direct comparison. Furthermore, in this section, we used tables showing the level of spherical aberration for each pupil size be-fore and after IOL implantation.

siMuLations in the eye With previous Myopic LasiKAs can be seen in Figure 1A, the Mini Well IOL

showed a well-defined peak for far vision and a smooth transition between the intermediate (-1.50 D)

Figure 1. Simulated through-focus modulated transfer function (MTF) obtained in simulations for pupil sizes of (a) 3, (b) 4, and (c) 4.7 mm with the Mplus (Oculentis GmbH, Berlin, Germany), Symfony (Johnson & Johnson Vision, Santa Ana, CA), and Mini Well (SIFI S.p.A., Lavinaio, Italy) intraocular lenses (IOLs) in the eye with previous myopic LASIK.

Figure 2. Simulated through-focus modulated transfer function (MTF) obtained in simulations for pupil sizes of (a) 3, (b) 4, and (c) 4.7 mm with the Mplus (Oculentis GmbH, Berlin, Germany), Symfony (Johnson & Johnson Vision, Santa Ana, CA), and Mini Well (SIFI S.p.A., Lavinaio, Italy) intraocular lenses (IOLs) in the eye with previous hyperopic LASIK.

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and near (-2.50 D) focus that was higher than for the rest of the IOLs for a pupil size of 3 mm. The Symfony IOL showed a wider far zone, but the MTF values for near (-2.50 D) and intermediate (-1.50 D) zones were narrower. The Mplus IOL showed the worst through-focus curve, including a peak for far vision and a lower peak for near vision (-3.50 D). For the 4-mm pupil size (Figure 1B), the Mini Well IOL improved the MTF for far vision and maintained two foci for near (-2.50 D) and intermediate (-1.50 D) vision, the Symfony IOL showed a similar behavior as for the 3-mm pupil, and the Mplus IOL worsened the through-focus curve for all defocus levels. For the 4.7-mm pupil size (Figure 1C), the Mini Well IOL showed the best through-focus curve for distance, intermediate, and near, the Sym-fony IOL only showed a lower peak for far vision, and the Mplus IOL did not provide any peak.

The spherical aberration of the eye with previous myopic LASIK changed from +0.087 µm for the 3-mm pupil to +0.57 µm for the 4.7-mm pupil without an IOL (Table 1).

siMuLations in the eye With previous hyperopic refractive surgery

In general, the best through-focus MTF values were obtained for the 3-mm pupil size because the three IOLs provided higher peaks (Figure 2A). The Mini Well IOL showed two peaks for far and intermediate distance (-1.50 D defocus). For near distance, a depth of focus between 3.50 and 5.50 D was observed. For the 3-mm pupil size, the Symfony IOL showed a wider area for far and intermediate vision (-1.00 D), with a smooth transition. However, for near vision, any fo-cus was obtained. The Mplus IOL showed a peak for near vision (-5.00 D) and another two lower peaks for -2.50 and -0.75 D defocus levels. For the 4-mm pupil

size (Figure 2B), the Mini Well IOL displayed a simi-lar behavior similar to the 3-mm pupil size but with decreased far vision MTF. With the Symfony IOL, the far focus diminished drastically and showed a wider area of focus for intermediate and near vision, between -1.50 and -3.00 D defocus levels. The best focus with the Mplus IOL was obtained for near (-3.00 D), with some focal increase of the MTF for intermediate and far vision. For the 4.7-mm pupil size (Figure 2C), the Mini Well IOL maintained the peak for far focus and displayed an extended depth of focus for near (-4.00 D), inducing some level of depth of focus for interme-diate vision (-1.50 D). The Symfony IOL only showed a wider focus for intermediate vision centered at the -2.50 D defocus level. The Mplus IOL did not show any focus for these pupil sizes (Figure 2).

The spherical aberration of the eye with previous hyperopic LASIK changed from -0.096 µm for the 3-mm pupil to -0.560 µm for the 4.7-mm pupil without an IOL (Table 1).

DISCUSSIONOur simulations have shown that the optical quali-

ty of the system eye and IOL is worsened in eyes with previous laser refractive surgery when the pupil size increases. This is consistent with the scientific evi-dence reported to date supporting the fact that laser refractive surgery leads to some level of aberrometric induction, even when aspheric profiles are used.1-4 Considering the spherical aberration, the three IOLs compensated for the positive spherical aberration of the eye that had undergone previous myopic LASIK and increased the negative spherical aberration of the eye that had undergone previous hyperopic LASIK. This suggests that a careful study of corneal aberra-tions should be performed before implanting multifo-

TABLE 1Spherical Aberration (µm) for Each IOL

3-mm Pupil 4-mm Pupil 4.7-mm Pupil

Case MW SYM MP MW SYM MP MW SYM MP

Myopic refractive surgery

Eye +0.087 +0.289 +0.57

IOL -0.128 -0.007 0.017 -0.121 -0.117 0.023 -0.111 -0.207 -0.298

Eye+IOL -0.038 0.085 0.110 0.181 0.188 0.329 0.484 0.395 0.325

Hyperopic refractive surgery

Eye -0.096 -0.289 -0.560

IOL -0.128 -0.007 0.017 -0.121 -0.117 0.023 -0.111 -0.207 -0.298

Eye+IOL -0.199 -0.092 -0.065 -0.373 -0.393 -0.242 -0.588 -0.734 -0.933

IOL = intraocular lens; MW = Mini Well, SIFI S.p.A., Lavinaio, Italy; SYM = Symfony, Johnson & Johnson Vision, Santa Ana, CA; MP = Mplus, Oculentis GmbH, Berlin, Germany

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cal IOLs in eyes with previous laser refractive surgery to control the potential aberrometric change induced by the IOL.

The analysis of the results in the eye with previ-ous myopic LASIK shows a better ocular optical qual-ity with the Mini Well and Symfony IOLs rather than with the Mplus IOL because the through-focus MTF achieves higher values. The Mini Well and Symfo-ny IOLs maintained the far focus independently of the pupil size, with the Mini Well IOL showing the highest MTF values as the pupil size increased. In general, the three IOLs evaluated lost some level of optical quality at near and intermediate distances for the 4- and 4.7-mm pupil sizes. For the 3-mm pupil size, the Mini Well IOL showed the best intermedi-ate and near ocular optical quality outcome. This is consistent with results of previous simulations per-formed in an optical bench evaluating the same IOLs in the ISO model eye with no previous refractive sur-gery.17-19 Domínguez-Vicent et al.18 showed that the Mini Well IOL provided two main focus areas in the ISO eye model: one corresponding to distance vi-sion focus and the other including both intermediate and near vision foci. Similar behavior was observed in our simulations, although the change induced in spherical aberration introduced some minimal modi-fications. The positive spherical aberration of the eye with previous myopic refractive LASIK was always compensated for with the IOLs evaluated and was maintained within acceptable clinical values for all pupil sizes. This compensation was higher for the Symfony and Mplus IOLs as the pupil size increased because the spherical aberration remained constant with the Mini Well IOL regardless of whether the pu-pil size increased.

In the eye with previous hyperopic refractive LASIK, the Mini Well IOL showed two peaks for intermediate and far distance and a wider area for near vision of ap-proximately -4.00 D of defocus for all pupil sizes. De-spite the Symfony IOL showing a wider focus area for far and intermediate distance for 3-mm pupil size, this area disappeared as the pupil size increased, with the presence of only a near focus (-2.50 D defocus level). The Mplus IOL only showed a near focus for the 3- and 4-mm pupil size for defocus levels of -4.50 and -3.00 D, respectively. All IOLs increased the level of nega-tive spherical aberration of the eye, leading to ocular values higher than -0.5 µm for 4.7-mm pupil size. This may be the reason for the worsening of the ocular opti-cal quality with the three IOLs for the highest pupil size evaluated. This suggests that this combination of previous hyperopic LASIK and presbyopic-correcting IOL should be only used in eyes with small pupil sizes

to avoid a potentially significant deterioration of the visual quality.

Our simulations suggest that the Mini Well and Symfony IOLs work better than the Mplus IOL in eyes with previous myopic LASIK. In general, there was a loss of near and intermediate optical quality for the three IOLs analyzed as the pupil size increased, with the Mini Well IOL showing the best intermediate and near optical quality performance for the 3-mm pupil size. For far distance, both the Mini Well and Sym-fony IOLs provided a good focus, showing that the Mini Well IOL had the highest MTF values. In eyes with previous hyperopic LASIK, our simulations indi-cated that the Mini Well IOL showed acceptable near, intermediate, and far foci for all pupil sizes. Both the Symfony and Mplus IOLs gradually lost the far focus, only showing a near or intermediate focus, as the pupil size increased.

A new method that combines in vitro IOL wave-front aberration measurement, real topographies, and ray-tracing simulation is able to simulate the ocular optical performance after presbyopia-correcting IOL implantation in eyes with previous laser refractive surgery. Although this new method is proposed, there is little validation of it; therefore, the results shown in this study are not generalizable because more patients should be analyzed. In future studies, larger sample sizes will be studied to confirm our results and deter-mine whether they are consistent with those obtained in clinical practice. It should be remembered that there are differences between experimental and clinical con-ditions because the eye is not a perfectly centered opti-cal system. Therefore, differences between IOLs might change in other conditions. Furthermore, this method-ology may be applied to other IOLs whose aberromet-ric pattern may be reproducible with Hartmann–Shack sensors.

AUTHOR CONTRIBUTIONSStudy concept and design (VJC, JJM, CG, AT, DPP); data collec-

tion (VJC, JJM, CG, AT, DPP); analysis and interpretation of data

(VJC, JJM, CG, AT, DPP); writing the manuscript (VJC, JJM, DPP);

critical revision of the manuscript (VJC, JJM, CG, AT, DPP); statisti-

cal expertise (VJC, DPP); administrative, technical, or material sup-

port (VJC, CG); supervision (VJC, JJM, DPP, CG)

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Figure A. Corneal topographic data of the two eyes used for the simula-tions: post-myopic LASIK (top) and post-hyperopic LASIK (bottom).