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Clinical science

Visual quality comparison of conventional and Hole-Visian implantable collamer lens at different degrees of decentering Cari Pérez-Vives, Teresa Ferrer-Blasco, David Madrid-Costa, Santiago García-Lázaro, Robert Montés-Micó GIO, Optics Department, Faculty of Physics, University of Valencia, Valencia, Spain Correspondence to Dr Cari Pérez-Vives, Optics Department, University of Valencia, C/Dr Moliner 50, Valencia 46100, Spain; [email protected] Received 5 June 2013 Accepted 29 September 2013 Published Online First 18 November 2013

ABSTRACT Purpose To compare the visual quality of implantable collamer lens (ICL) with and without central hole (Hole ICL and conventional ICL) at different degrees of decentering. Methods An adaptive optics visual simulator (crx1, Imagine Eyes, Orsay, France) was used to simulate the –3, –6 and –12 dioptres (D) conventional and Hole ICLs in three conditions: centred and decentred 0.3 and 0.6 mm. Visual acuity (VA) at high-contrast, mediumcontrast and low-contrast and contrast sensitivity (CS) were measured in 15 observers for 3 and 4.5 mm pupils. Results No statistically significant differences in VA and CS were found between conventional and Hole ICLs for any ICL powers and pupil sizes evaluated ( p>0.05). Regarding the effect of the ICL decentration on visual performance, we did not find statistically significant differences in VA and CS between centred, 0.3 and 0.6 mm decentred ( p>0.05). Moreover, the ICL decentration affected the same manner on the conventional and Hole ICLs. Conclusions The outcomes showed that conventional and Hole ICLs provided good and comparable visual performance for all powers and pupil sizes evaluated. Besides, ICL decentering affects the same manner both ICL models evaluated. The ICL decentering did not have any effect on the visual performance.

INTRODUCTION

To cite: Pérez-Vives C, Ferrer-Blasco T, MadridCosta D, et al. Br J Ophthalmol 2014;98: 59–64.

The implantable collamer lens (ICL, STAAR Surgical, Nidau, Switzerland) is a posterior phakic intraocular lens implantation approved by the US Food and Drug Administration (FDA) for myopia correction. Several studies have shown the safety and effectiveness of the ICL to correct myopia,1 2 hyperopia3 4 and astigmatism.5 6 However, several complications have been reported.7 Complications include increased intraocular pressure,8 endothelial cells loss,9 pupillary block,10 pigment dispersion,11 glaucoma8 10 11 and anterior subcapsular cataract.12–15 Anterior subcapsular opacities result from surgical trauma or continuous ICL and crystalline lens contact because of insufficient vaulting.12–15 On the other hand, Fujisawa et al16 reported that another cause of secondary cataract formation may be the poor circulation of the aqueous humour that induces an ICL implantation. In order to reduce some complications and disadvantages, the ICL designs have undergone different improvements. The latest model is V4c Visian Implantable Collamer Lens, which has been

Pérez-Vives C, et al. Br J Ophthalmol 2014;98:59–64. doi:10.1136/bjophthalmol-2013-303787

designed with a central hole of 0.36 mm to improve the aqueous humour circulation17 and eliminates the need to perform neodymium:YAG (Nd:YAG) iridotomy or peripheral iridectomy before ICL implantation. Shiratani et al18 showed that an ICL with a hole of 1.0 mm in diameter in the centre of the optic did not degrade the performance of the ICL compared with the conventional version, and it is sufficient to increase the aqueous humour perfusion volume on the anterior surface of the crystalline lens, preventing cataract formation. Pérez-Vives et al19 compared the optical quality of conventional and Hole ICLs, measured in vitro, at different degrees of decentering. They found comparable optical quality between both designs of ICLs, without statistical differences between them. The effect of decentering equally affects both conventional and Hole ICLs. Shimizu et al20 21 evaluated the visual performance with the Hole ICL implanted. They showed that Hole ICL is a safe, effective, predictable and stable procedure to correct high to moderate myopia. The aim of the present study was to compare the visual performance provided by conventional ICL and Hole ICL for three powers (–3, –6 and –12 dioptres (D)) and evaluate the effect of decentering (0.3 and 0.6 mm) on the visual performance. For this purpose, we used an adaptive-optics system to simulate vision from the ICL’s aberration pattern itself. Visual acuity (VA) for different contrast and contrast sensitivity (CS) were evaluated for 3 and 4.5 mm pupils.

MATERIALS AND METHODS This study included 15 eyes of 15 individuals, aged 21–28 and having all experience in psychophysical experiments. Spherical refractive errors ranged between −1.50 and +0.25 D with astigmatism 0.05).

DISCUSSION The aim of the present study was to simulate and compare the vision provided by conventional and Hole ICLs at different refractive powers and at different degrees of decentering. This method allows us to evaluate and compare the patient’s visual quality without the need of ICL implantation, analysing the effect of ICL model and ICL decentering effect.

RESULTS Figures 2 and 3 show high-contrast, medium-contrast and lowcontrast VA outcomes for –3, –6 and –12 D conventional and Hole ICLs for centred, 0.3 and 0.6 mm decentered positions at 3 and 4.5 mm pupils, respectively. We did not find statistically significant differences in VA values between conventional and Hole ICLs at any ICL powers, decentered position and for both pupils ( p>0.05). Regarding the effect of decentering, no statistically significant differences were found between centred and decentered positions for any ICL powers and pupils evaluated ( p>0.05). Figures 4 and 5 show the mean log10 CS values for –3, –6 and –12 D conventional and Hole ICLs for centred, 0.3 and 0.6 mm decentered positions at 3 and 4.5 mm pupils, respectively. No statistically significant differences were found in CS values between conventional and Hole ICLs at any refractive power, decentered positions and pupil sizes ( p>0.05). In relation to the effect of decentering on both types of ICLs, we did

Effect of the hole on the optical quality VA values achieved with conventional and Hole ICLs at different degrees of decentering and for both pupils were good, obtaining values above 20/20 at high and medium contrast for all ICL powers. At low contrast, VA values were favourable too, about 20/30 for all powers of conventional and Hole ICLs, at different degrees of decentering and for both pupils. No statistically significant differences were found between conventional and Hole ICLs at any ICL power, any decentering position and both pupils ( p>0.05; see figures 2 and 3). These outcomes agree with those obtained by Shimizu et al.20 They analysed the early outcomes of 20 eyes of 20 patients implanted with Hole ICL to correct moderate and high myopia (mean spherical equivalent −7.36±2.13 D). They found that the mean uncorrected VA was −0.20 logMAR and 100% of eyes had uncorrected VA of 20/20 or better 6 months after surgery.

Figure 2 Visual acuity logMAR at high contrast (100%), medium contrast (50%) and low contrast (10%) for –3 (top left), –6 (top right) and –12 D (bottom left) of conventional and Hole implantable collamer lens at different degrees of decentering (legend, bottom right) at 3 mm pupil. Access the article online to view this figure in colour. Pérez-Vives C, et al. Br J Ophthalmol 2014;98:59–64. doi:10.1136/bjophthalmol-2013-303787

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Clinical science

Figure 3 Visual acuity logMAR at high contrast (100%), medium contrast (50%) and low contrast (10%) for –3 (top left), –6 (top right) and –12 D (bottom left) of conventional and Hole implantable collamer lens at different degrees of decentering (legend, bottom right) at 4.5 mm pupil. Access the article online to view this figure in colour. In terms of CS, for conventional and Hole ICLs, the CS function was good and comparable, and we did not find statistically significant differences between conventional and Hole ICLs at different degrees of decentering and both pupils ( p>0.05; see figures 4 and 5). Shimizu et al21 compared postoperative visual performance after Hole ICL implantation in one eye and conventional ICL implantation in the other eye to correct moderate and high myopia (mean spherical equivalent −7.55±2.09 D). They evaluated the HOAs and photopic and mesopic CS function 3 months after surgery at 4 and 6 mm pupils. They concluded that after the Hole ICL implantation, the postoperative area under the log CS function was equivalent to that after conventional ICL implantation under photopic and mesopic conditions. Besides, Hole ICL implantation induced similar HOAs than conventional ICL implantation. This studio also agrees with our simulating outcomes that Hole ICL implantation provided similar outcomes in CS than conventional ICL implantation in real patients. Pérez-Vives et al19 measured the HOAs of conventional and Hole ICLs in vitro at different degrees of decentering for 3 and 4.5 mm pupil. They did not find statistically significant differences in any Zernike coefficient terms evaluated between conventional and Hole ICLs for any ICL powers and pupil sizes. Moreover, they also evaluated the point spread function (PSF) and simulated retinal images of ICLs calculated from the ICLs’ wavefront aberrations. They did not find differences in the PSF and simulated retinal images since both ICL models showed similar wavefront aberrations values without differences between them at any refractive power evaluated. These 62

outcomes also show that the differences between both ICL models are minimal and clinically negligible.

Effect of ICL decentering on the optical quality The effect of the ICL decentration on visual performance was also evaluated in the present study. We found that VA values at centred, 0.3 and 0.6 mm decentered were good and comparable for both pupils and all ICL powers, without statistically significant differences between them ( p>0.05; see figures 2 and 3). Regarding the CS outcomes, the effect of decentering did not affect the CS values, and we did not find statistically significant differences in CS results between centred and decentered positions ( p>0.05; figures 4 and 5). Moreover, ICL decentering affects the same manner both ICL models. Pérez-Vives et al19 found that ICL decentration induced coma aberration, which was greater when the ICL power and pupil size increased; statistically significant differences were found in coma aberration between centred and both degrees of decentering for all ICLs and pupils evaluated. However, they found the PSFs and simulated retinal images showed low influence of coma aberration increment, since they could not appreciate the visible differences between centred and decentered ICL positions. Therefore, they concluded that the increment of coma, due to the ICL decentering, was expected to not affect the visual quality of a patient implanted with the lens since these increments were less than 0.025 and 0.072 mm at 3 and 4.5 mm pupils. These changes in coma RMS values do not affect the visual performance.25 The present study confirms this fact; although the ICLs have been implanted in an eye, the coma

Pérez-Vives C, et al. Br J Ophthalmol 2014;98:59–64. doi:10.1136/bjophthalmol-2013-303787

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Clinical science

Figure 4 Mean log contrast sensitivity plotted as a function of spatial frequency (10, 20 and 25 cycles/degree (cpd)) for –3 (top left), –6 (top right) and –12 D (bottom left) of conventional and Hole implantable collamer lens at different degrees of decentering (legend, bottom right) at 3 mm pupil. Access the article online to view this figure in colour.

Figure 5 Mean log contrast sensitivity plotted as a function of spatial frequency (10, 20 and 25 cycles/degree (cpd)) for –3 (top left), –6 (top right) and –12 D (bottom left) of conventional and Hole implantable collamer lens at different degrees of decentering (legend, bottom right) at 4.5 mm pupil. Access the article online to view this figure in colour. Pérez-Vives C, et al. Br J Ophthalmol 2014;98:59–64. doi:10.1136/bjophthalmol-2013-303787

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Clinical science increment when the ICL is decentered does not affect the visual performance. The visual simulator allows us to evaluate the impact of different IOLs and different conditions on visual performance before the surgical procedure takes place. However, we must take into account several limitations of our study, such as the surgery effects, ICL tilt or other postoperative complications,7 which may affect the outcomes reported here. In summary, the outcomes of the present study show that conventional and Hole ICLs provide good and comparable visual performance for all powers and pupils sizes evaluated. Moreover, ICL decentering affects the same manner both ICL models evaluated. The ICL decentering did not have any effect on the visual performance, like Pérez-Vives et al19 predicted in their study.

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Contributors DM-C and RM-M made substantial contributions to conception and design. CP-V and TF-Bwere responsible for acquisition of data. SG-Lmade substantial contributions to analysis and interpretation of data. CP-V made substantial contributions of drafting the article. TF-B and DM-Cwere responsible for revising the article. RM-M gave the final approval of the version to be published. Funding This research was supported in part by the research grant awarded by the Spanish Ministry of Science and Innovation to RM-M (#SAF2009-13342#) and a VALi+D research scholarship to CP-V (ACIF/2012/099, GeneralitatValenciana). Competing interests None.

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Patient consent Obtained. Ethics approval Institutional Review Board at the University of Valencia-Research Group of Optometry. Provenance and peer review Not commissioned; externally peer reviewed.

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Pérez-Vives C, et al. Br J Ophthalmol 2014;98:59–64. doi:10.1136/bjophthalmol-2013-303787

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Visual quality comparison of conventional and Hole-Visian implantable collamer lens at different degrees of decentering Cari Pérez-Vives, Teresa Ferrer-Blasco, David Madrid-Costa, et al. Br J Ophthalmol 2014 98: 59-64 originally published online November 18, 2013

doi: 10.1136/bjophthalmol-2013-303787

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References

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Visual quality comparison of conventional and Hole-Visian implantable collamer lens at different degrees of decentering.

To compare the visual quality of implantable collamer lens (ICL) with and without central hole (Hole ICL and conventional ICL) at different degrees of...
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