Vargas et al. Eye and Vision (2020) 7:34 https://doi.org/10.1186/s40662-020-00200-8 RESEARCH Open Access Safety and visual outcomes following posterior chamber phakic intraocular lens bilensectomy Veronica Vargas1, Jorge L. Alió1,2 , Rafael I. Barraquer3,4,5, Justin Christopher D’ Antin3,4, Cristina García6, Francisco Duch7, Joan Balgos1 and Jorge L. Alió del Barrio1,2* Abstract Background: To evaluate the safety, efficacy, refractive outcomes and causes for bilensectomy (phakic intraocular lens – pIOL – explantation with cataract surgery and pseudophakic intraocular lens implantation) in patients previously implanted with posterior chamber pIOLs. Methods: This multi-center retrospective study included 87 eyes of 55 patients who underwent bilensectomy for posterior chamber pIOL with a follow up time of 12 months. The uncorrected and best corrected distance visual acuities (UDVA, CDVA), endothelial cell density before and after bilensectomy were assessed, as well as the cause of bilensectomy and intra or postoperative complications. Results: There was a statistically significant improvement in uncorrected and best corrected visual acuities after bilensectomy (p = 0.00). The main reason for bilensectomy was cataract development (93.1% of the cases), followed by miscalculation of lens size, and corneal edema. The endothelial cell count remained stable without a statistically significant change after surgery (p = 0.67). The refractive efficacy index was 0.8, none of the patients lost lines of CDVA after surgery, 73% of the patients were within ±1 D (spherical equivalent) of the target refraction. Intraoperative complications were one posterior capsule rupture with the intraocular lens (IOL) implanted in the sulcus, and 3 eyes required the use of pupil expanders for adequate pupil dilation. Postoperatively, one eye developed retinal detachment. The three pIOLs models explanted were the Implantable Collamer Lens (ICL), Implantable Phakic Contact Lens (IPCL) and the Phakic Refractive Lens (PRL). Conclusions: Good safety and visual outcomes were observed 1 year after bilensectomy for posterior chamber phakic intraocular lenses (PC pIOLs). There were few intra and postoperative complications and there was no significant endothelial cell loss after the bilensectomy procedure. Keywords: Bilensectomy, Posterior chamber phakic intraocular lenses, Cataract, Endothelial cell count, Visual outcomes, Postoperative complications, Intraoperative complications * Correspondence: jlalio@vissum.com 1 Vissum Instituto Oftalmológico de Alicante, Alicante, Spain 2 Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Vargas et al. Eye and Vision (2020) 7:34 Page 2 of 8 Background Indications for bilensectomy were the following: cata- The correction of high ametropias with phakic intraocular ract development with loss of two or more lines of cor- lenses (pIOL) has the advantage of excellent visual out- rected distance visual acuity (CDVA) or ECC < 1200 comes, accommodation maintenance, and reversibility; cells/mm2. contrary to laser refractive surgery [1–4]. Posterior cham- Preoperative assessment included: uncorrected dis- ber phakic intraocular lenses (PC pIOLs) are widely used, tance visual acuities (UDVA) and CDVA respectively and their implantation is relatively easy. Furthermore, they measured with ETDRS charts, slit lamp examination, have long-term predictable and stable results for the cor- Goldmann applanation tonometry, fundus examination, rection of myopia [1], hyperopia [2] and astigmatism [3, and central ECC measurements taken with a noncontact 4]. Nowadays, the commercially available PC pIOLs are specular microscope (Noncon Robo-CA, Konan). The the Implantable Collamer Lens (Staar Surgical Co, Mon- intraocular lens (IOL) to be implanted was calculated riva, California) and the Implantable Phakic Contact Lens preoperatively using interferometry (IOLMaster, Carl (IPCL, Care Group Sight solutions, India). Other PC Zeiss Meditec AG). The SRK-T formula with the Wang/ pIOLs like the phakic refractive lens (PRL, Zeiss Meditec, Koch adjustment was used and the target refraction was Jena, Germany) were phased out from the market due to emmetropia in all cases. Bilensectomy was performed by associated long term complications [5]. four experienced surgeons (JLA, JIB, RIB, FD). A monofo- In spite of all the possible advantages that a pIOL may cal or multifocal IOL was implanted depending on pa- offer, all patients with a pIOL will eventually undergo tients’ postoperative visual expectations, preoperative bilensectomy (pIOL explantation with cataract surgery ophthalmic examination, daily activities (intermediate and and posterior chamber intraocular lens – IOL – implant- near visual needs), and age. Toric IOLs were implanted in ation), either due to a pIOL-induced cataract or the devel- those patients with a topographic astigmatism > 1.5 D. opment of an age-related cataract. Many studies have The technique for pIOL removal was as follows: Two reported the causes and incidence of cataract after the im- 1 mm side ports were created, intracameral mydriatic plantation of a PC pIOL [6–8], but few have really re- was used to dilate the pupil and dispersive viscoelastic ported the clinical outcomes after bilensectomy [9], with (Viscoat, Alcon) was injected to protect the corneal only a few clinical cases available [10, 11]. The aim of this endothelium. A 3.2 mm clear corneal incision was made. study is to evaluate the safety, efficacy, refractive out- The 4 footplates of the pIOL were carefully lifted into comes, and indications for bilensectomy in patients with the anterior chamber and carefully explanted through posterior chamber pIOLs, with a minimum postoperative the main incision. Coaxial phacoemulsification was per- follow up of 12 months. To the best of our knowledge, this formed with implantation of a posterior chamber IOL. A is the only study that describes the outcomes of bilensect- cohesive viscoelastic (Provisc, Alcon) was used to keep omy with different models of posterior chamber pIOLs. the capsular bag open for IOL insertion. After injecting intracameral antibiotic, the main incision and paracen- tesis were hydrated and sealed (Additional file 1). Post- Methods operative medications included topical antibiotics for a This is a retrospective, multicenter study, involving 87 week and steroids tapered over 4 weeks. eyes that had bilensectomy after PC pIOL implantation. The main outcome measures were: efficacy (UDVA All data was obtained from the IBERIA biobank.1 The after bilensectomy / CDVA after bilensectomy), percent- Spanish centers that participated in this study were: Vis- age of eyes in which the postoperative CDVA was worse sum Alicante (Alicante), and Vissum Madrid (Madrid), than the preoperative CDVA (safety), refractive predict- Centro de Oftalmología Barraquer (Barcelona), and the ability and central ECC change. The secondary outcomes Instituto Catalán de Retina-ICR (Barcelona). This study were: bilensectomy etiology, and intra/postoperative was approved by the local research ethics committees complications. and was performed in compliance with the principles of the Declaration of Helsinki. Statistical analysis Indications for the implantation of PC pIOLs were the Statistical analysis was performed with the SPSS software following: ametropia that could not be corrected with for Windows (version 15.0.1). The average values and corneal laser refractive surgery (extremely high myopes standard deviations were calculated for every parameter. or patients with thin corneas), anterior chamber depth Normality of all data was evaluated by means of the greater than 2.8 mm, irido-corneal angle greater than Kolmogorov-Smirnov test. When parametric analysis 30°, endothelial cell count (ECC) > 2500 cells/mm2. was possible, the Student’s t test for paired data was per- formed for all parameter comparison between preopera- 1 IBERIA Biobank is a Collection of Intraocular Lenses and Other tive and postoperative examinations. When parametric Ocular Explanted Devices in Spain and Portugal. analysis was not possible, the Wilcoxon test was applied Vargas et al. Eye and Vision (2020) 7:34 Page 3 of 8 to assess the significance of differences between pre- (spherical equivalent) of the attempted correction (Fig. 5). operative and postoperative data. For all statistical tests Regarding the refractive cylinder, 28.5% of the eyes had a p value less than 0.05 was considered statistically a postoperative value < 0.5 D (Fig. 6). Endothelial cell significant. density did not significantly change after surgery (p = 0.67). Results Two eyes required a combined bilensectomy with tra- The mean follow up time after bilensectomy was beculectomy, postoperatively the IOP was controlled 14.5 ± 5.6 months. The mean age at bilensectomy was with a good final visual outcome (CDVA of 20/35). One 44.4 ± 7.3 years. The most frequent cause for bilensectomy eye had a combined bilensectomy with pupilloplasty was cataract development (84 eyes), followed by corneal with a final CDVA of 20/25, and one eye had a com- edema (1 eye), IOL dislocation (1 eye), refractive surprise bined bilensectomy with Descemet’s stripping automated (1 eye). Anterior subcapsular opacification was the most endothelial keratoplasty (DSAEK). common type of cataract (43%) followed by the posterior We had one case with pIOL (PRL) dislocation second- subcapsular opacification (Figs. 1 and 2). Of the three ary to broken zonules, this patient did not present with models of pIOLs explanted, 72 were ICL (models V3 and any intra or postoperative complications. His final V4, and one V4c), 7 were IPCL and 8 were PRL. The CDVA was 20/25. mean time between the pIOL implantation and bilensect- Thirteen multifocal IOLs were implanted, all the omy was 85.2 ± 61.59 months. Table 1 shows the mean rest were monofocal IOLs. The multifocal IOLs time between the implantation of each type of PC pIOL implanted were: Lentis Mplus LS 313 MF + 1.5D model and their subsequent bilensectomy. The preopera- and + 3.0D (Oculentis GmbH, Berlin, Germany), AT tive and postoperative outcomes are presented in Table 2. Lisa tri 389 MP (Carl Zeiss Meditec, Henningsdorf, The mean preoperative and postoperative UDVA and Germany), FineVision (PhysIOL SA, Liège, Belgium), CDVA of each pIOL model are presented in Table 3. ReSTOR AD1 (Alcon Lab, Fort Worth, Texas, USA), Sixty-eight percent of the patients had an UCVA of 20/40 Versario Multifocal 3F IOL (Valeant Med Sp.zo.o., or better, and 86% had a CDVA of 20/40 or better (Fig. 3). Warsaw, Poland) and AcriLISA 366D Carl Zeiss Med- Thirty nine percent of the patients had the same uncor- itec, Jena, Germany). rected and corrected visual acuities postoperatively (Fig. 4). The visual outcome of these patients was good with a None of the eyes had a postoperative CDVA worse than mean UDVA of 20/35, CDVA of 20/25 and an efficacy the preoperative. index of 0.8. Forty six percent of the patients implanted The efficacy index was 0.8 (mean UDVA postop/ mean with a multifocal IOL were younger than 45 years, none CDVA postop), 73% of the eyes were within ±1.00 D of them had any postoperative optical complication. Fig. 1 Percentage of the different types of cataracts presented in our study Vargas et al. Eye and Vision (2020) 7:34 Page 4 of 8 Fig. 2 Type and percentage of cataracts developed by each phakic IOL model Intraoperative complications were as follows: one eye We found a significant improvement in both UDVA had a posterior capsule rupture with the IOL implanted and CDVA after bilensectomy, with an acceptable effi- in the sulcus, 3 eyes required the use of pupil expanders cacy index and good safety that correlates to the findings for adequate pupil dilation. from other studies [9, 10]. Eighty six percent of our pa- Postoperative complications were as follows: as an tients had a final CDVA of 20/40 or better. This appar- early complication, one eye had a retinal detachment ently limited visual outcome is influenced by the (RD) immediately after the surgery, eventually attaining concomitant retinal comorbidities of some of these high a final CDVA of 20/130 after pars plana vitrectomy, this myopic patients such as previous RD (one eye had a RD visual outcome was still better than the one he had be- one year after the implantation of the pIOL), foveoschi- fore the bilensectomy (counting fingers). sis, and myopic chorioretinal atrophy - all complications As a late complication, four eyes presented with pos- connected to high myopia [15]. terior capsule opacification that was successfully treated Intra and postoperative complications were few, although with neodymium-doped yttrium-aluminum-garnet (Nd: one of them was sight-threatening (RD) and directly con- YAG) laser capsulotomy. nected to the high myopia suffered by these patients. Refractive outcomes were good, with a significant im- provement in the sphere and spherical equivalent. The Discussion SRK-T formula with the Wang/Koch adjustment had Refractive surgeons should consider the explantation of good results, although nowadays the Barret Universal II all phakic IOLs at some point [12]; either due to the in- formula is more accurate for the IOL calculation in cases cidence of cataract after the implantation of PC pIOLs [13, 14] or the development of an age-related cataract, a Table 2 Preoperative and postoperative visual and refractive bilensectomy will be necessary in those patients, there- results fore it is important to report the long term outcomes of Preoperative Postoperative P value such procedures. Mean ± SD Mean ± SD UCVA (logMAR) 0.88 ± 0.63 0.31 ± 0.28 0.00 Table 1 Time in months between phakic IOL implantation and Sphere (D) −0.63 ± 2.6 0.66 ± 1.1 0.00 bilensectomy Cylinder (D) − 0.92 ± 1.08 −0.94 ± 0.84 0.71 Phakic IOL model Time Spherical equivalent (D) − 1.10 ± 2.5 0.20 ± 1.2 0.00 Mean ± SD ICL 99.3 ± 43.7 CDVA (logMAR) 0.43 ± 0.44 0.15 ± 0.19 0.00 IPCL 5.5 ± 2.7 Endothelial cell density 2212 ± 667 2168 ± 618 0.67 (cells/mm2) PRL 67.1 ± 52.1 SD= standard deviation, UCVA= uncorrected distance visual acuity, CDVA= ICL= Implantable Collamer Lens, IPCL= Implantable Phakic Contact Lens, PRL= corrected distance visual acuity Phakic Refractive Lens Vargas et al. Eye and Vision (2020) 7:34 Page 5 of 8 Table 3 Mean preoperative and postoperative UCVA, CDVA of each pIOL model pIOL model UCVA UCVA P value CDVA CDVA P value preoperative postoperative preoperative postoperative ICL (n: 72) 20/175 20/40 0.00 20/50 20/25 0.00 IPCL (n: 7) 20/80 20/25 0.01 20/35 20/20 0.01 PRL (n: 8) 20/60 20/30 0.08 20/50 20/25 0.04 pIOL= phakic intraocular lens, UCVA= uncorrected distance visual acuity, CDVA= corrected distance visual acuity with extreme myopia (AL > 28 mm) [16]. The different time was 8.2 ± 3.3 years for the ICL, which corroborate methods that can be used for IOL calculation in the pres- with the results from Meier et al. [9], but not with the ence of a pIOL are: standard ultrasound biometry, intraop- ones from Kamiya et al. [10] (3.6 years). We assume that erative ultrasound biometry, intraoperative autorefraction the difference in time was due to the ICL model, as and partial coherence interferometry [17]. We used the lat- Kamiya et al. [10] explanted more V2 models, which had ter as it provides adequate measurements in eyes with a higher rate of cataract formation [22]. The mean time pIOLs [18]. between the IPCL implantation and bilensectomy was The cylinder did not change after the bilensectomy; short (0.4 years) compared to the other two PC pIOL our outcomes agree with those reported in a previous models. A study [23] reported cataract formation within study [9]. 1 year of IPCL implantation in 2.9% of the eyes studied, In a previous study [19], as well as in this study, cataract although only one eye required bilensectomy, with good was the main cause for phakic IOL explantation. Anterior final visual outcome (CDVA 20/25). subcapsular opacification is the most common type of The PRL has been phased out the market due to its cataract after the implantation of a pIOL and it is pre- associated complications [5, 24]. It has been reported sumed to be caused by the contact between the crystalline that contact with the haptics of the PRL causes zonu- lens and the pIOL, trauma during surgery, intermittent lar weakening which results in the dislocation of the trauma from accommodation, subclinical inflammation, pIOL [25]. Furthermore, patients with high axial my- insufficient vaulting, lens malnutrition and crystalline lens opia have weaker zonules due to the excessive trauma from preoperative Nd:YAG laser peripheral iridot- stretching of the zonular fibers [24], and both factors omy [6, 20]. The development of cataract with the latest might have contributed to the dislocation of the pIOL model of ICL (V4c) is less common than with older in our patient. models [7] due to the central hole that reduces the risk of We had one combined procedure of bilensectomy and cataract formation. The ICL (Fig. 7) was the most DSAEK secondary to endothelial cell loss; a study [26] explanted PC pIOL, which is explained by the fact that it reported good visual outcomes and graft survival in eyes is the most widely implanted PC pIOL [21]. undergoing this combined procedure. Endothelial cell The time between PC pIOL implantation and bilen- loss rate after PC pIOL implantation differs between sectomy differ depending on the pIOL model: the mean clinical studies [27–29]. It has been reported that there Fig. 3 Histogram of postoperative CDVA and UCVA Vargas et al. Eye and Vision (2020) 7:34 Page 6 of 8 Fig. 4 Histogram of lines of difference between postoperative UDVA and CDVA is no chronic loss of endothelial cells after the implant- years) than the patients in other studies [9, 10] (mean ation of a PC pIOL [30], because there is no direct con- age of 47.2 and 50.39 years). tact between the pIOL and the corneal endothelium. On One eye required pupilloplasty due to a hyporeactive the other hand, an 8-year follow up study [31] reported mydriatic pupil. Although pupillary defects are not com- a mean percentage of endothelial cell loss of 6.2% after mon after the implantation of PC pIOLs, cases of fixed the implantation of the ICL pIOL. mydriatics pupils secondary to Urrets-Zavalia syndrome We did not observe a significant loss in ECC after have been reported [34, 35]. Probably, pupil-related visual bilensectomy, so the procedure does not seem to signifi- problems are an under reported feature in PC pIOL cantly damage the corneal endothelium. implantation. High myopic eyes and young patients (< 50 years) have Two eyes required a combined procedure with trabe- a higher risk of RD [31–33] after cataract surgery. There culectomy: these eyes had pigment over the trabecular was one case of RD in our study. This finding does not meshwork and high intraocular pressure. Sanchez- agree with previous studies [9–11] where no cases of RD Galeana et al. [36] reported a case of intractable pigmen- were reported after PC pIOL bilensectomy. This might tary glaucoma that required pIOL explantation and tra- be secondary to our higher number of patients and the beculectomy in order to control the IOP. Pigment fact that our patients were younger (mean age of 44.4 dispersion is related to chronic chafing by the pIOL. Fig. 5 Postoperative spherical equivalent refraction Vargas et al. Eye and Vision (2020) 7:34 Page 7 of 8 Fig. 6 Postoperative refractive cylinder One of the main limitations of this study is that we postoperative complication that should be monitored in could not get the vault measurement of the PC pIOL be- young patients. fore the bilensectomy surgery to ascertain its potential correlation with the cataract development. Supplementary information To the best of our knowledge, this is a study with the Supplementary information accompanies this paper at https://doi.org/10. 1186/s40662-020-00200-8. largest number of eyes and the longest follow up time (mean 14.5 months) after PC pIOL bilensectomy, and Additional file 1: Video S1 the only one that reports the outcomes of three different types of PC pIOLs. Acknowledgements Not applicable. Conclusions Authors’ contributions In conclusion, the main cause for bilensectomy following Veronica Vargas: Design of the work, data acquisition, analysis and interpretation. Jorge L. Alió: Design of the work, analysis and review. Joan PC-pIOL implantation was cataract development in our Balgos, Rafael I Barraquer and Justin Christopher D’ Antin: data acquisition, sample, and the visual and refractive outcomes were ac- review. Cristina García and Francisco Duch: data acquisition. Jorge Alió del ceptable. It was a safe procedure in which we did not Barrio: data acquisition, analysis and review. All authors read and approved the final manuscript. observe significant endothelial cell loss, and with few intra or postoperative complication rates. RD is a serious Funding This study has been supported in part by the Red Temática de Investigación Cooperativa en Salud (RETICS), reference number RD16/0008/0012, financed by the Instituto Carlos III – General Subdirection of Networks and Cooperative Investigation Centers (R&D&I National Plan 2008–2011) and the European Regional Development Fund (Fondo Europeo de Desarrollo Regional FEDER). Availability of data and materials The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Ethics approval and consent to participate The study was performed according to the tenets of the Declaration of Helsinki of 1964, as revised in 2013 (Fortaleza, Brazil). The protocol was reviewed by the Ethics Committee of Vissum Alicante. Consent for publication Not applicable. Fig. 7 Posterior chamber phakic intraocular lens Competing interests None of the other authors have any financial disclosures. Vargas et al. Eye and Vision (2020) 7:34 Page 8 of 8 Author details 18. Pitault G, Leboeuf C, Leroux les Jardin S, Auclin F, Chong-Sit D, Baudouin C. 1 Vissum Instituto Oftalmológico de Alicante, Alicante, Spain. 2Division of [Optical biometry of eyes corrected by phakic intraocular lenses]. J Fr Ophthalmology, Universidad Miguel Hernández, Alicante, Spain. 3Institut Ophthalmol 2005; 28(10):1052–1057. Universitari Barraquer, Universitat Autònoma de Barcelona, Barcelona, Spain. 19. Alió JL, Toffaha BT, Peña-Garcia P, Sádaba LM, Barraquer RI. Phakic intraocular 4 Centro de Oftalmología Barraquer, Barcelona, Spain. 5Universitat lens explantation: causes in 240 cases. J Refract Surg. 2015;31(1):30–5. 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