Long Term Assessment of the Quality of Visual-related Daily Activities after ICL (V4C) Implantation for Myopia and Myopic Astigmatism

Long Term Assessment of the Quality of Visual-related Daily Activities after ICL (V4C) Implantation for Myopia and Myopic Astigmatism | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Long Term Assessment of the Quality of Visual-related Daily Activities after ICL (V4C) Implantation for Myopia and Myopic Astigmatism Shaorong Linghu, Taixiang Liu, Yilu Liao, Rong Shi, Le Pan This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.2.79/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background : The purpose of the study was to evaluate long-term quality of visual related daily activities after Central Hole Collamer Lens implantation to treat myopia and myopic astigmatism. Methods : This retrospective study included 46 eyes (23 patients) receiving an ICL-V4c implantation. The follow up time was at least 24 m. Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction, eye axis, intraocular pressure, endothelial cell density (ECD), vault, and the patients’ satisfaction related to vision related daily activities were recorded at 6 m and 24 m. Results: The mean spherical equivalents were -0.14 ± 0.21 D and -0.12 ± 0.33 D at 6 m and 24 m after surgery, respectively. UCVA of all eyes were equal to or better than preoperative BCVA. The BCVA at 6 m and 24 m after implantation were -0.03 ± 0.08 LogMAR, and −0.03 ± 0.11 LogMAR, respectively, which was statistically better ( P = 0.031) than that of pre-operation value of 0.07 ± 0.12 LogMAR. There was no significant differences ( P > 0.05) between the pre operation and post operation ECD.At 24 m post operation, 10% of the patients complained of difficulty driving at night, but most of patient had satisfactory or very satisfactory vision-related daily activity scores. Some patients, 13%, were worried about the long-term safety and efficacy of the V4c-ICL implantation. Conclusions : Patients were very satisfied with their vision related daily activities after V4c-ICL implantation. With time, some patients worried about the permanent safety and efficacy. Internal Medicine Specialties Implantable Collamer Lens vision related daily activities long-term safety and efficacy Figures Figure 1 Figure 2 Figure 3 Figure 4 Background The Vision Implantable Collamer® Lens (ICL, STAAR Surgical, Minrovia CA, USA) with a central artificial hole is a promising next-generation surgical option for the treatment of moderate to high myopia, with excellent visual performance. Posterior chamber phakic intraocular lens (pIOL) implantation has become an important and inevitable choice for young patients with high myopia[1, 2]. After implantation, the ICL-V4c closes the refractive system nodes, and has less image change and surgical injury, so it has high visual quality and better security compared to the laser refractive surgical[3, 4]. An advantage of posterior chamber IOL implantation is that the integrity of eye is maintained and the surgery is safely reversible, unlike ocular lens extraction surgery in which the native ocular lens is removed. ICL is made from a collagen copolymer which is highly biocompatibile[5]. The new V4C lens is better than that the older V4 lens because it has a 0.36mm central hole[6, 7]which allows for the circulation of aqueous in a natural manner minimizing iridectomy and reducing the risk of cataract.About the endothelial cell lossing, the U.S. FDA Trial demonstrated that it was 3.3±7.6% at one year postoperatively(90% confidence limits: 2.4% to 4.3%)[8]. Fernandes and colleague[9] reported that the mean endothelial cell loss varied from 9.9% to 3.7% at 2-4 years postoperatively,and that those loss was more prominented within the first 1 to 2 years,but over time ,the ECD was stability or lower progression. Despite the advantages of V4c implantation, complications, such as cataract and elevated IOP levels were observed[10]. Objective and subjective short-term visual quality after ICL implantation has been studied extensively[11] . Some patients complained about halo or glare in dark environments[12]which can cause nighttime driving difficulty, and some patients worried about the safety and the efficacy in the long-term of the implantation. Long-term visual quality assessment of visual related daily activities in a complex living environment after ICL implantation have not been studied. To ameliorate this gap in knowledge, we assessed the quality of visual related daily activities 24 months after ICL-V4c implantation. Patients and Methods The current study included 46 eyes of 23 consecutive patients (mean age 24.04 ± 4.75 years, standard deviation [SD] range 18 - 35 years, including 13 men) who had a posterior chamber phakic collamer (ICL-V4c) implanted at the Affiliated Hospital of Zunyi Medical College. The mean spherical equivalent was -11.25 ±3.23 D (range, -5.25 D to -15.75 D); the average cylinder was -3.27±0.83 D (range, -1.25 D to -4.5 D). Preoperative and postoperative uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) were recorded using the decimal method and converted into the LogMAR (logarithm of the minimal angle of resolution) equivalence. All patients were followed for at least 24 m. The UCVA, BCVA, refraction, eye axis, intraocular pressure, endothelial cell density (ECD), vault, and the patients’ satisfaction related to their quality of vision related daily activities at 6 m and 24 m were recorded. One senior technician used ultrasound biomicroscopy (UBM) to measure the ICL-V4c central vault and the peripheral vault at 2, 4, 8, and 10 o’clock at 1 m, 6 m and 24 m postoperative. All patients filled out a visual satisfaction questionnaire related to daily vision-related activities. The questionnaire was modified slightly from the questionnaire developed by the Corneal Disease and Excimer Laser Research Unit, University of Dundee, Scotland[13]. This study complied with the Helsinki declaration of the purpose, and all patients gave their informed consent after a comprehensive explanation of the possible risk and complication of V4c-ICL implantation. Inclusion Criteria . Inclusion criteria was: refraction did not change more than 0.5 D one year after surgery; BCVA was 0.5 or above; contact lenses were not worn for more than two weeks; no obvious eye diseases; a horizontal white-to-white distance between 10.5 and 12.5 mm; the number of corneal endothelial cells had to be greater than 2500mm -2; the central anterior chamber depth had to be more than 2.8mm. Intraocular Lens. ICL power calculation was performed using the instructions of the manufacturer (STAAR Surgical, Monrovia CA, USA). The emmetropia was the target refraction and the type of the ICL-V4c was chosen following the manufacturer’s instructions and based on the anterior chamber depth and the horizontal corneal diameter. The horizontal white-to-white(W-T-W) distance was took by manual measurement. Surgical Procedure On the day of surgery, patients were given dilating and cycloplegic agents. Topical anesthesia was performed using 0.4% proparacaine before surgery. If a Toric ICL was implanted, the zero horizontal axis was marked by means of a slit-lamp preoperatively. A 3 mm clear corneal incision and the pre-installed ICL was slowly pushed into the anterior chamber through the incision. A special adjustment hook was used to adjust it into the posterior chamber, and then replaced the viscoelastic agent. All surgeries were performed by one experienced surgeon. Statistical Analysis All data were expressed as means ± SD. The preoperative and postoperative axial, IOP and ECD was analyzed using repeated analysis of variance (SPSS 17.0). The Student’s T-test was used to test differences in the central vault, peripheral vaults and postoperative satisfaction score. A value of P < 0.05 was considered statistically significant. Results Refraction and Visual Parameters. Preoperative SE was - 11.3 ± 3.7 D (-5.25 D to -15.75 D). SE were -0.14 ± 0.21 D (-1.00 to 0.75 D) and -0.12 ± 0.33 D (-1.00 to 0.50 D), postoperative 6 m and 24 m, respectively. Preoperative Log MAR UCVA was 1.4 ± 0.2 LogMAR ,−0.03 ± 0.07 LogMAR and -0.03 ± 0.09 LogMAR postoperative 6 m and 24 m, respectively. All of the 46 eyes had a UCVA equal to or better than the preoperative BCVA(Fig.1). The efficacy indexes were 1.21 and 1.24 (postoperative UCVA/preoperative BCVA). The BCVA at 6m and 24m after operation were -0.03 ± 0.08 LogMAR, −0.03 ± 0.11 LogMAR respectively, which was better than that of pre-operation (0.07 ± 0.12 LogMAR) (P=0.033).The safety index were 1.24 and 1.26(=postoperative BCVA/preoperative BCVA). The average preoperative axial length was 26.9 ± 1.3 mm, and the average postoperative axial length was 27.1 ± 1.3 mm at 24 m ( P > 0.05). Fig.1 The change of BCVA after ICL-V4Cimplantation. -2 line：Postoperative BCVA decreased by two line; -1 line: Postoperative BCVA decreased by one line; 0 line: postoperative BCVA equal to preoperative values; 1 line: Postoperative BCVA increased by one line; 2 line: Postoperative BCVA increased by two lines. Intraocular pressure. There was no significant differences ( P > 0.05) between the pre operation and post operation IOP (Fig. 2). Fig.2 The change of IOP after ICL-V4Cimplantation. Corneal Endothelial Cells Density There was no significant differences ( P > 0.05) between the pre operation and post operation ECD (Fig. 3). Fig.3 The ECD before and 1m, 6m and 24m after V4c-ICL Vault The central vault, 0.46 ± 0.26 mm (0.1 to 0.70 mm) was significantly higher, P < 0.05 compared with the peripheral vault (Fig. 4) at all post operation times. During our follow-up, the central and peripheral vaults were gradually declined with time. At the first 6m after V4c-ICL implantation, the central vault showed a quickly downward trend and then the change of vault was very slowly. In addition, our data showed that the high vault declined more obviously. Fig.4 The central and peripheral vault after V4c-ICL implantation Visual Function. All of the 23 patients were required to fill out a questionnaire related to visual functions 6 m and 24 m after surgery. The results of the questionnaire are listed in Table 1. Items one and two were related to near vision, items three through five were related to far distance vision, item six was related to night vision, and items seven through eleven were related to middle-distance vision. Apart from the 10 % of patients that complained of difficulty driving at night 24 m post operation, all of the other items received satisfactory or very satisfactory scores. We also investigated whether patients had halos after surgery During the early postoperative follow-up period, the halos occurred in 12 patients (52.2%) in a dark environment, while halos were gradually reduced or disappeared over time. Only one patient had a halo that persisted in a dark environment. All of the patients gave satisfactory or very satisfactory scores for all the other items. A few patients, 13%, voluntarily informed us that they worried about the long-term efficacy of V4c-ICL implantation, however after six months post operation, there were no similar complaints. see Table 1 Discussion UCVA, BCVA and safety index measured in in the current study after V4c-ICL implantation in all eyes were equal or better than preoperative BCVA. No eyes had postoperative BCVA worse than preoperative BCVA. The majority of patients (95.65%) with BCVA improved in a row or more. The safety index at 6 m and 24 m post operation were consistent with a previous study[14] . No significant change was found in the eye axial length . which for patients with high myopia, is realted to refraction[15]. These results indicated that V4c-ICL was a safe and effective treatment for high myopia, and refraction was stable over time. IOP for all patients was stable and similar to the preoperative level. A high IOP is one of the main problems after ICL implantation. The cause for early postoperative higher IOP levels include: excessive residual viscoelastic agent, an ICL that was too large, or a vault that was too high. The cause for mid-term higher IOP levels include steroid induced higher IOP; long term iris depigmentation, pigmentation blockage or chronic angle synechiae closure. All of the above risks were minimized due to the 0.36 mm central hole . Maintenance of ECD is important for maintaining corneal transparency. Endothelial cells numbering about 5500 / mm2 lose their proliferation ability after birth and decrease normally by about 0.32% to 0.6% every year[16]. Intraocular surgery, corneal trauma, endophthalmitis and high IOP can the decrease ECD.In this study, we found that the number of corneal endothelial cells at 1m, 6m, and 24m after V4c-ICl implantation decreased by 3.92%, 4.83%, 5.02% respectively. Although not statistically significant, we found a trend towards a decrease in ECD after V4c-ICl implantation. We consider the factors of endothelial cell injury was surgical techniques, artificial lens and change of aqueous humor of physicochemical properties in the early postoperative stage. While from 6m to 24m after V4c-ICL implantation, there had no obvious change about the ECD. Of course, a longer-term observation time and a larger sample size would be advantageous to document ECD changes with time. Postoperative vault was a determinant of major complications after ICL surgery. Acceptable levels of postoperative vault for the V4C-ICL was defined as 250 to 750 μm[17]. The vault was too low may increase the risk of cataract formation[18]. And the vault was too high will made the iris bulging forward, close to anterior chamber angle, and lead to the elevated IOP and iris dysfunction[19]. In the present study, we used ultrasound biomicroscopy to observe the distance between ICL and natural lens ,we found there were no V4c-ICL contact with lens directly .In the early period of postoperative follow-up, the vault was shown a downward trend, and quickly decreased at first 3m after V4c-ICL implantation, and the higher vault mean more change. And then the change of vault gradually slowed over time. This result was consistent with the previous studies [10, 19]. The peripheral vault was significantly lower than the central vault, which may ensure the optical imaging quality of V4C-ICL.Because the concave lens has the thin central area ( 40 um), the outer edge of optical thickness was 500-600um, and the haptic foot plates thickness was less than 100 um. This design allows the V4C-ICL to have the smallest refractive index, and ensure its high order aberration was smaller, to improve the quality of optical imaging. Evaluation of visual quality after ICL implantation was the focus of many studies[14, 15, 20]. Objective parameters such as contrast sensitivity and high-order aberration after V4c-ICL implantation were measured[21, 22]. There are no studies published regarding long-term vision-related daily activities, so we pursued this aim in the present study. Most of the patients we studied had satisfactory or very satisfactory visual function scores while 10% patients complained of difficulty driving at night. Some patients complained of halos appearing in a dark environment. Haloes may arise from high contrast in a night time environment, and/or the central hole affecting diffraction causing the glare[12]. Our patients with glare complaints were given psychological counseling and with time the glare problems gradually disappeared without any treatment. Some of the patients, 13%, voluntarily informed us that they worried about the permanent safety and efficacy after V4c-ICL implantation. During the 6 m follow-up, there were no similar complaints. Adequate preoperative communication, regular and long-term follow-up is important to relieve the patients' worries. Conclusions In summary, refraction and IOP were stable and there was no change in ECD or vault over a 24 m follow-up time. At 24 m post operation, 10% of the patients complained of difficulty driving at night, but most of patient had satisfactory or very satisfactory vision-related daily activity scores. Some patients, 13%, were worried about the long-term efficacy of the V4c-ICL implantation. V4c-ICL implantation appears to be safe and effective, however a follow up period greater than 24 m and a larger sample size would are necessary to validate the long term safety and efficacy of the implantation. Declarations Acknowledgments This study was supported in part by the National Nature Science Foundation of China (no. 81660169) and the Department of Science and Technology of Guizhou (no. ZC220160310). Funding The project from the Department of Science and Technology of Guizhou (no. ZC220160310): design of the study and collection, analysis, and interpretation of data. The project from This study was supported in part by the National Nature Science Foundation of China (no. 81660169): write the manuscript and pay for a professional language editing service. Availability of data and materials The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request. Authors’ contributions Literature screening and selection was performed by SR Linghu and TX Liu. SR Linghu and YL Liao participated in the design of the study. SR Linghu drafted the manuscript.L Pan and R Shi carried out the statistical analysis. SR Linghu and TX Liu prepare and review of the manuscript. TX Liu has given final approval of the version to be published. All authors read and approved the final manuscript. Ethics approval and consent to participate This study was conducted in accordance with the principles of the Declaration of Helsinki and was approved by the Ethics Committee of the Affiliated Hospital of Zunyi Medical College. Written informed consent was obtained from all patients after the nature and possible consequences of the study were explained. Consent for publication Not applicable. Competing Interests The authors declare that there is no conflict of interests regarding the publication of this article. Publisher’s Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Contributor Information Shaorong Linghu, Email: [email protected] . Taixiang,Liu, Email: [email protected] Yilu Liao,Email: [email protected] Rong Shi, Email: [email protected] Le Pan, Email: [email protected] References 1. Kocová H, Vlková E, Michalcová L, Motyka O. Implantation of posterior chamber phakic intraocular lens for myopia and hyperopia - long-term clinical outcomes. J Fr Ophtalmol. 2017;40(3):215-23. doi:10.1016/j.jfo.2016.10.009. 2. Rodríguez-Una I, Rodríguez-Calvo PP, Fernández-Vega CL, Lisa C, Fernández-Vega CA, Alfonso JF. Intraocular Pressure After Implantation of a Phakic Collamer Intraocular Lens With a Central Hole. J Refract Surg. 2017;33(4):244-9. doi:10.3928/1081597X-20170110-01. 3. 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Tables Visual Mean score Very % Positive% Negative% Very functions ±SD positive negative % 6m / 24m Reading in daylight 8.7±0.77 / 8.8±0.8 72.3 / 73.1 27.7/ 26.9 0 0 Reading in artificial light 8.7±0.76 / 8.9±0.7 74.2 / 76.8 25.8/ 23.2 0 0 Watching TV 8.9±0.81 / 9.0±0.78 77.4 / 77.2 22.6/ 22.8 0 0 Watching movie at cinema 8.8±0.72 / 8.8±0.6 80.0 / 81.9 20.0/18.1 0 0 Driving in daylight 8.7±0.82 / 8.7±0.7 77.5 / 76.9 22.5/23.1 0 0 Driving at night 8.0±0.79 / 8.2±0.9 55.2 / 52.6 38.8/37.4 6/10 0 Reading computer 8.0±0.69 / 8.3±0.5 55.9 / 55.5 44.1/44.5 0 0 screen Playing sports 8.8±0.81 / 8.8±0.8 77.2 / 77.6 22.8/22.4 0 0 Swimming 8.5±0.67 / 8.8±0.7 74.5 / 73.6 22.5/23.1 0 0 Shaving/makeup 8.6±0.91 / 8.8±0.7 81.4 / 82.3 18.6/17.7 0 0 Shopping 8.9±0.74 / 9.0 ±0.6 82.9 / 81.2 17.1/18.8 0 0 Table 1: The visual function questionnaire for all 23 patients after ICL implantation Note: the score is 10 points, which stated that 7.5-10.0 is very satisfied, 5.0-7.5 is satisfied; 2.5-5.0 points is negative; 0-2.5 is very negative. 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Liu","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAyElEQVRIiWNgGAWjYBACPgjFDMIHDnz4QYQWNjYgcQCkhY0t8eDMHtK08Bgf5mAjRot8j/Hnj23WcubyPR8OM/AwyPOLHSBkC1uaxMG2dGPLNt4NhwssGAxnzk4gpIX5GMPBtsOJG44BtczgYUgwuE1QC2PzB6CW+g3HeB4c5mEjSgvzAaDDDicYHONhIFZLWprEmXPphhuOpRkAA1mCsF/4mc8Yf6gos5Y3OHz48YcPP2zk+aUJaEEHEqQpHwWjYBSMglGAHQAAv+RCONtYPyYAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-5168-3468","institution":"","correspondingAuthor":true,"prefix":"","firstName":"Taixiang","middleName":"","lastName":"Liu","suffix":""},{"id":1359,"identity":"bf4b1f6a-ffce-11e8-bede-0aeebd4cf34e","order_by":0,"name":"Yilu Liao","email":"","orcid":"","institution":"Affiliated Hospital of Zunyi Medical college","correspondingAuthor":false,"prefix":"","firstName":"Yilu","middleName":"","lastName":"Liao","suffix":""},{"id":1360,"identity":"bf4b2230-ffce-11e8-bede-0aeebd4cf34e","order_by":0,"name":"Rong Shi","email":"","orcid":"","institution":"Affiliated Hospital of Zunyi Medical college","correspondingAuthor":false,"prefix":"","firstName":"Rong","middleName":"","lastName":"Shi","suffix":""},{"id":1361,"identity":"bf4b243c-ffce-11e8-bede-0aeebd4cf34e","order_by":0,"name":"Le Pan","email":"","orcid":"","institution":"Affiliated Hospital of Zunyi Medical college","correspondingAuthor":false,"prefix":"","firstName":"Le","middleName":"","lastName":"Pan","suffix":""}],"badges":[],"createdAt":"2018-12-11 17:39:20","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.2.79/v1","doiUrl":"https://doi.org/10.21203/rs.2.79/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":587263,"identity":"6f3b29f5-f296-4942-8710-96da27cb9c40","added_by":"auto","created_at":"2020-03-03 17:00:25","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":80841,"visible":true,"origin":"","legend":"The change of BCVA after ICL-V4C implantation","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-79/v1/Figure 1.jpg"},{"id":587264,"identity":"fe60d68e-3cf5-47cd-b13d-4fd005cc87ee","added_by":"auto","created_at":"2020-03-03 17:00:25","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":128441,"visible":true,"origin":"","legend":"The change of IOP after ICL-V4C implantation","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-79/v1/Figure 2.jpg"},{"id":587265,"identity":"b1482e9a-7920-42a9-b50d-79fbae90faf1","added_by":"auto","created_at":"2020-03-03 17:00:26","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":129295,"visible":true,"origin":"","legend":"The ECD before and 1m, 6m and 24m after V4c-ICL","description":"","filename":"Figure3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-79/v1/Figure 3.jpg"},{"id":587266,"identity":"ea1a048f-4a43-4825-ae86-1f844efdbc33","added_by":"auto","created_at":"2020-03-03 17:00:26","extension":"jpg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":115559,"visible":true,"origin":"","legend":"The central and peripheral vault after V4c-ICL implantation","description":"","filename":"Figure4.jpg","url":"https://assets-eu.researchsquare.com/files/rs-79/v1/Figure 4.jpg"},{"id":13465878,"identity":"762c8248-f756-441f-a64b-ed78b2d376a9","added_by":"auto","created_at":"2021-09-16 20:48:36","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":666719,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-79/v1/94afeb24-1859-4bb6-b61c-1fc85638cf94.pdf"}],"financialInterests":"","formattedTitle":"Long Term Assessment of the Quality of Visual-related Daily Activities after ICL (V4C) Implantation for Myopia and Myopic Astigmatism","fulltext":[{"header":"Background","content":"\u003cp\u003eThe Vision Implantable Collamer® Lens (ICL, STAAR Surgical, Minrovia CA, USA) with a central artificial hole is a promising next-generation surgical option for the treatment of moderate to high myopia, with excellent visual performance. Posterior chamber phakic intraocular lens (pIOL) implantation has become an important and inevitable choice for young patients with high myopia[1, 2]. After implantation, the ICL-V4c closes the refractive system nodes, and has less image change and surgical injury, so it has high visual quality and better security compared to the laser refractive surgical[3, 4]. An advantage of posterior chamber IOL implantation is that the integrity of eye is maintained and the surgery is safely reversible, unlike ocular lens extraction surgery in which the native ocular lens is removed. ICL is made from a collagen copolymer which is highly biocompatibile[5]. The new V4C lens is better than that the older V4 lens because it has a 0.36mm central hole[6, 7]which allows for the circulation of aqueous in a natural manner minimizing iridectomy and reducing the risk of cataract.About the endothelial cell lossing, the U.S. FDA Trial demonstrated that it was 3.3±7.6% at one year postoperatively(90% confidence limits: 2.4% to 4.3%)[8]. Fernandes and colleague[9] reported that the mean endothelial cell loss varied from 9.9% to 3.7% at 2-4 years postoperatively,and that those loss was more prominented within the first 1 to 2 years,but over time ,the ECD was stability or lower progression. Despite the advantages of V4c implantation, complications, such as cataract and elevated IOP levels were observed[10]. Objective and subjective short-term visual quality after ICL implantation has been studied extensively[11] . Some patients complained about halo or glare in dark environments[12]which can cause nighttime driving difficulty, and some patients worried about the safety and the efficacy in the long-term of the implantation. \u003c/p\u003e\n\u003cp\u003eLong-term visual quality assessment of visual related daily activities in a complex living environment after ICL implantation have not been studied. To ameliorate this gap in knowledge, we assessed the quality of visual related daily activities 24 months after ICL-V4c implantation.\u003c/p\u003e"},{"header":"Patients and Methods","content":"\u003cp\u003eThe current study included 46 eyes of 23 consecutive patients (mean age 24.04 ± 4.75 years, standard deviation [SD] range 18 - 35 years, including 13 men) who had a posterior chamber phakic collamer (ICL-V4c) implanted at the Affiliated Hospital of Zunyi Medical College. The mean spherical equivalent was -11.25 ±3.23 D (range, -5.25 D to -15.75 D); the average cylinder was -3.27±0.83 D (range, -1.25 D to -4.5 D). Preoperative and postoperative uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) were recorded using the decimal method and converted into the LogMAR (logarithm of the minimal angle of resolution) equivalence. All patients were followed for at least 24 m. The UCVA, BCVA, refraction, eye axis, intraocular pressure, endothelial cell density (ECD), vault, and the patients’ satisfaction related to their quality of vision related daily activities at 6 m and 24 m were recorded.\u003c/p\u003e\n\u003cp\u003eOne senior technician used ultrasound biomicroscopy (UBM) to measure the ICL-V4c central vault and the peripheral vault at 2, 4, 8, and 10 o’clock at 1 m, 6 m and 24 m postoperative. All patients filled out a visual satisfaction questionnaire related to daily vision-related activities. The questionnaire was modified slightly from the questionnaire developed by the Corneal Disease and Excimer Laser Research Unit, University of Dundee, Scotland[13]. This study complied with the Helsinki declaration of the purpose, and all patients gave their informed consent after a comprehensive explanation of the possible risk and complication of V4c-ICL implantation.\u003c/p\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eInclusion Criteria\u003c/i\u003e\u003c/b\u003e. Inclusion criteria was: refraction did not change more than 0.5 D one year after surgery; BCVA was 0.5 or above; contact lenses were not worn for more than two weeks; no obvious eye diseases; a horizontal white-to-white distance between 10.5 and 12.5 mm; the number of corneal endothelial cells had to be greater than 2500mm -2; the central anterior chamber depth had to be more than 2.8mm. \u003c/p\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eIntraocular Lens.\u003c/i\u003e \u003c/b\u003eICL power calculation was performed using the instructions of the manufacturer (STAAR Surgical, Monrovia CA, USA). The emmetropia was the target refraction and the type of the ICL-V4c was chosen following the manufacturer’s instructions and based on the anterior chamber depth and the horizontal corneal diameter. The horizontal white-to-white(W-T-W) distance was took by manual measurement.\u003c/p\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eSurgical Procedure\u003c/i\u003e\u003c/b\u003e\u003c/p\u003e\n\u003cp\u003eOn the day of surgery, patients were given dilating and cycloplegic agents. Topical anesthesia was performed using 0.4% proparacaine before surgery. If a Toric ICL was implanted, the zero horizontal axis was marked by means of a slit-lamp preoperatively. A 3 mm clear corneal incision and the pre-installed ICL was slowly pushed into the anterior chamber through the incision. A special adjustment hook was used to adjust it into the posterior chamber, and then replaced the viscoelastic agent. All surgeries were performed by one experienced surgeon. \u003c/p\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eStatistical Analysis\u003c/i\u003e\u003c/b\u003e\u003c/p\u003e\n\u003cp\u003e All data were expressed as means ± SD. The preoperative and postoperative axial, IOP and ECD was analyzed using repeated analysis of variance (SPSS 17.0). The Student’s T-test was used to test differences in the central vault, peripheral vaults and postoperative satisfaction score. A value of \u003ci\u003eP\u003c/i\u003e \u0026lt; 0.05 was considered statistically significant. \u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003ca name=\"OLE_LINK33\"/\u003e\u003ca name=\"OLE_LINK34\"/\u003e\u003ca name=\"OLE_LINK92\"/\u003e\u003ca name=\"OLE_LINK93\"/\u003e\u003cb\u003e\u003ci\u003eRefraction and Visual Parameters.\u003c/i\u003e \u003c/b\u003ePreoperative SE was - 11.3 ± 3.7 D (-5.25 D to -15.75 D). SE were -0.14 ± 0.21 D (-1.00 to 0.75 D) and -0.12 ± 0.33 D (-1.00 to 0.50 D), postoperative 6 m and 24 m, respectively. Preoperative Log MAR UCVA was 1.4 ± 0.2 LogMAR ,−0.03 ± 0.07 LogMAR and -0.03 ± 0.09 LogMAR postoperative 6 m and 24 m, respectively. All of the 46 eyes had a UCVA equal to or better than the preoperative BCVA(Fig.1). The efficacy indexes were 1.21 and 1.24 (postoperative UCVA/preoperative BCVA). The BCVA at 6m and 24m after operation were -0.03 ± 0.08 LogMAR, −0.03 ± 0.11 LogMAR respectively, which was better than that of pre-operation (0.07 ± 0.12 LogMAR) (P=0.033).The safety index were 1.24 and 1.26(=postoperative BCVA/preoperative BCVA). The average preoperative axial length was 26.9 ± 1.3 mm, and the average postoperative axial length was 27.1 ± 1.3 mm at 24 m (\u003ci\u003eP \u003c/i\u003e\u0026gt; 0.05). \u003c/p\u003e\n\u003cp\u003e\u003cb\u003eFig.1 The change of BCVA after ICL-V4Cimplantation.\u003c/b\u003e -2 line：Postoperative BCVA decreased by two line; -1 line: Postoperative BCVA decreased by one line; 0 line: postoperative BCVA equal to preoperative values; 1 line: Postoperative BCVA increased by one line; 2 line: Postoperative BCVA increased by two lines. \u003c/p\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eIntraocular pressure.\u003c/i\u003e\u003c/b\u003e There was no significant differences (\u003ci\u003eP\u003c/i\u003e \u0026gt; 0.05) between the pre operation and post operation IOP (Fig. 2). \u003c/p\u003e\n\u003cp\u003e\u003cb\u003eFig.2 The change of IOP after ICL-V4Cimplantation.\u003c/b\u003e\u003c/p\u003e\n\u003cp\u003e\u003ca name=\"OLE_LINK1\"/\u003e\u003cb\u003eCorneal Endothelial Cells Density\u003c/b\u003e There was no significant differences (\u003ci\u003eP\u003c/i\u003e \u0026gt; 0.05) between the pre operation and post operation ECD (Fig. 3).\u003c/p\u003e\n\u003cp\u003e\u003cb\u003eFig.3 The ECD before and 1m, 6m and 24m after V4c-ICL \u003c/b\u003e\u003c/p\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eVault\u003c/i\u003e \u003c/b\u003eThe central vault, 0.46 ± 0.26 mm (0.1 to 0.70 mm) was significantly higher, \u003ci\u003eP \u003c/i\u003e\u0026lt; 0.05 compared with the peripheral vault (Fig. 4) at all post operation times. During our follow-up, the central and peripheral vaults were gradually declined with time. At the first 6m after V4c-ICL implantation, the central vault showed a quickly downward trend and then the change of vault was very slowly. In addition, our data showed that the high vault declined more obviously. \u003c/p\u003e\n\u003cp\u003e\u003cb\u003eFig.4 The central and peripheral vault after V4c-ICL implantation\u003c/b\u003e\u003c/p\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eVisual Function.\u003c/i\u003e \u003c/b\u003eAll of the 23 patients were required to fill out a questionnaire related to visual functions 6 m and 24 m after surgery. The results of the questionnaire are listed in Table 1. Items one and two were related to near vision, items three through five were related to far distance vision, item six was related to night vision, and items seven through eleven were related to middle-distance vision. Apart from the 10 % of patients that complained of difficulty driving at night 24 m post operation, all of the other items received satisfactory or very satisfactory scores. \u003c/p\u003e\n\u003cp\u003eWe also investigated whether patients had halos after surgery During the early postoperative follow-up period, the halos occurred in 12 patients (52.2%) in a dark environment, while halos were gradually reduced or disappeared over time. Only one patient had a halo that persisted in a dark environment. All of the patients gave satisfactory or very satisfactory scores for all the other items. A few patients, 13%, voluntarily informed us that they worried about the long-term efficacy of V4c-ICL implantation, however after six months post operation, there were no similar complaints. see Table 1 \u003c/p\u003e\n"},{"header":"Discussion","content":"\u003cp\u003eUCVA, BCVA and safety index measured in in the current study after V4c-ICL implantation in all eyes were equal or better than preoperative BCVA. No eyes had postoperative BCVA worse than preoperative BCVA. The majority of patients (95.65%) with BCVA improved in a row or more. The safety index at 6 m and 24 m post operation were consistent with a previous study[14] . No significant change was found in the eye axial length . which for patients with high myopia, is realted to refraction[15]. These results indicated that V4c-ICL was a safe and effective treatment for high myopia, and refraction was stable over time.\u003c/p\u003e\n\u003cp\u003eIOP for all patients was stable and similar to the preoperative level. A high IOP is one of the main problems after ICL implantation. The cause for early postoperative higher IOP levels include: excessive residual viscoelastic agent, an ICL that was too large, or a vault that was too high. The cause for mid-term higher IOP levels include steroid induced higher IOP; long term iris depigmentation, pigmentation blockage or chronic angle synechiae closure. All of the above risks were minimized due to the 0.36 mm central hole . \u003c/p\u003e\n\u003cp\u003eMaintenance of ECD is important for maintaining corneal transparency. Endothelial cells numbering about 5500 / mm2 lose their proliferation ability after birth and decrease normally by about 0.32% to 0.6% every year[16]. Intraocular surgery, corneal trauma, endophthalmitis and high IOP can the decrease ECD.In this study, we found that the number of corneal endothelial cells at 1m, 6m, and 24m after V4c-ICl implantation decreased by 3.92%, 4.83%, 5.02% respectively. Although not statistically significant, we found a trend towards a decrease in ECD after V4c-ICl implantation. We consider the factors of endothelial cell injury was surgical techniques, artificial lens and change of aqueous humor of physicochemical properties in the early postoperative stage. While from 6m to 24m after V4c-ICL implantation, there had no obvious change about the ECD. Of course, a longer-term observation time and a larger sample size would be advantageous to document ECD changes with time.\u003c/p\u003e\n\u003cp\u003ePostoperative vault was a determinant of major complications after ICL surgery. Acceptable levels of postoperative vault for the V4C-ICL was defined as 250 to 750 μm[17]. The vault was too low may increase the risk of cataract formation[18]. And the vault was too high will made the iris bulging forward, close to anterior chamber angle, and lead to the elevated IOP and iris dysfunction[19]. In the present study, we used ultrasound biomicroscopy to observe the distance between ICL and natural lens ,we found there were no V4c-ICL contact with lens directly .In the early period of postoperative follow-up, the vault was shown a downward trend, and quickly decreased at first 3m after V4c-ICL implantation, and the higher vault mean more change. And then the change of vault gradually slowed over time. This result was consistent with the previous studies [10, 19]. The peripheral vault was significantly lower than the central vault, which may ensure the optical imaging quality of V4C-ICL.Because the concave lens has the thin central area ( 40 um), the outer edge of optical thickness was 500-600um, and the haptic foot plates thickness was less than 100 um. This design allows the V4C-ICL to have the smallest refractive index, and ensure its high order aberration was smaller, to improve the quality of optical imaging.\u003c/p\u003e\n\u003cp\u003eEvaluation of visual quality after ICL implantation was the focus of many studies[14, 15, 20]. Objective parameters such as contrast sensitivity and high-order aberration after V4c-ICL implantation were measured[21, 22]. There are no studies published regarding long-term vision-related daily activities, so we pursued this aim in the present study. Most of the patients we studied had satisfactory or very satisfactory visual function scores while 10% patients complained of difficulty driving at night. Some patients complained of halos appearing in a dark environment. Haloes may arise from high contrast in a night time environment, and/or the central hole affecting diffraction causing the glare[12]. Our patients with glare complaints were given psychological counseling and with time the glare problems gradually disappeared without any treatment. \u003c/p\u003e\n\u003cp\u003eSome of the patients, 13%, voluntarily informed us that they worried about the permanent safety and efficacy after V4c-ICL implantation. During the 6 m follow-up, there were no similar complaints. Adequate preoperative communication, regular and long-term follow-up is important to relieve the patients' worries.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eIn summary, refraction and IOP were stable and there was no change in ECD or vault over a 24 m follow-up time. At 24 m post operation, 10% of the patients complained of difficulty driving at night, but most of patient had satisfactory or very satisfactory vision-related daily activity scores. Some patients, 13%, were worried about the long-term efficacy of the V4c-ICL implantation. V4c-ICL implantation appears to be safe and effective, however a follow up period greater than 24 m and a larger sample size would are necessary to validate the long term safety and efficacy of the implantation.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cb\u003eAcknowledgments\u003c/b\u003e\u003c/p\u003e\n\u003cp\u003e\u003ca name=\"OLE_LINK5\"/\u003eThis study was supported in part by the National Nature Science Foundation of China (no. 81660169) and the Department of Science and Technology of Guizhou (no. ZC220160310).\u003c/p\u003e\n\u003cb\u003eFunding\u003c/b\u003e\n\u003cp\u003eThe project from the Department of Science and Technology of Guizhou (no. ZC220160310): design of the study and collection, analysis, and interpretation of data. The project from This study was supported in part by the National Nature Science Foundation of China (no. 81660169): write the manuscript and pay for a professional language editing service.\u003c/p\u003e\n\u003cb\u003eAvailability of data and materials\u003c/b\u003e\n\u003cp class=\"normal_(Web)\"\u003eThe datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request. \u003c/p\u003e\u003cb\u003eAuthors’ contributions\u003c/b\u003e\n\u003cp\u003e\u003ca name=\"OLE_LINK6\"/\u003eLiterature screening and selection was performed by SR Linghu and TX Liu. SR Linghu and YL Liao participated in the design of the study. SR Linghu drafted the manuscript.L Pan and R Shi carried out the statistical analysis. SR Linghu and TX Liu prepare and review of the manuscript. TX Liu has given final approval of the version to be published. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003ca name=\"OLE_LINK9\"/\u003e\u003cb\u003eEthics approval and consent to participate\u003c/b\u003e\n\u003cp class=\"normal_(Web)\"\u003eThis study was conducted in accordance with the principles of the Declaration of Helsinki and was approved by the Ethics Committee of the Affiliated Hospital of Zunyi Medical College. Written informed consent was obtained from all patients after the nature and possible consequences of the study were explained.\u003c/p\u003e\n\u003cb\u003eConsent for publication\u003c/b\u003e\n\u003cp class=\"normal_(Web)\"\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cb\u003eCompeting Interests\u003c/b\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that there is no conflict of interests\u003cb\u003e \u003c/b\u003eregarding the publication of this article.\u003c/p\u003e\n\u003cb\u003ePublisher’s Note\u003c/b\u003e\n\u003cp class=\"normal_(Web)\"\u003eSpringer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.\u003c/p\u003e\n\u003cp class=\"normal_(Web)\"\u003e\u003cb\u003eContributor Information\u003c/b\u003e\u003c/p\u003e\n\u003ca name=\"OLE_LINK7\"/\u003eShaorong Linghu, Email: [email protected].\n\u003ca name=\"OLE_LINK12\"/\u003eTaixiang,Liu, Email: [email protected]\n\u003ca name=\"OLE_LINK11\"/\u003eYilu Liao,Email: [email protected]\n\u003cp class=\"normal_(Web)\"\u003eRong Shi, Email:[email protected]\u003c/p\u003e\n\u003cp class=\"normal_(Web)\"\u003eLe Pan, Email: [email protected]\u003c/p\u003e"},{"header":"References","content":"\u003cp\u003e1. Kocová H, Vlková E, Michalcová L, Motyka O. Implantation of posterior chamber phakic intraocular lens for myopia and hyperopia - long-term clinical outcomes. J Fr Ophtalmol. 2017;40(3):215-23. doi:10.1016/j.jfo.2016.10.009.\u003c/p\u003e\n\u003cp\u003e2. Rodríguez-Una I, Rodríguez-Calvo PP, Fernández-Vega CL, Lisa C, Fernández-Vega CA, Alfonso JF. Intraocular Pressure After Implantation of a Phakic Collamer Intraocular Lens With a Central Hole. J Refract Surg. 2017;33(4):244-9. doi:10.3928/1081597X-20170110-01.\u003c/p\u003e\n\u003cp\u003e3. Kamiya K, Shimizu K, Igarashi A, Kitazawa Y, Kojima T, Nakamura T, et al. Posterior chamber phakic intraocular lens implantation: comparative, multicentre study in 351 eyes with low-to-moderate or high myopia. Br J Ophthalmol. 2018;102(2):177-81. doi:10.1136/bjophthalmol-2017-310164.\u003c/p\u003e\n\u003cp\u003e4. Bhikoo R, Rayner S, Gray T. Toric implantable collamer lens for patients with moderate to severe myopic astigmatism: 12-month follow-up. Clin Exp Ophthalmol. 2010;38(5):467-74. doi:10.1111/j.1442-9071.2010.02273.x.\u003c/p\u003e\n\u003cp\u003e5. Rosen E, Gore C. Staar Collamer posterior chamber phakic intraocular lens to correct myopia and hyperopia. J Cataract Refract Surg. 1998;24(5):596-606. \u003c/p\u003e\n\u003cp\u003e6. Hyun J, Lim DH, Eo DR, Hwang S, Chung ES, Chung TY. A comparison of visual outcome and rotational stability of two types of toric implantable collamer lenses (TICL) : V4 versus V4c. PLoS One. 2017;12(8):e0183335. doi:10.1371/journal.pone.0183335.\u003c/p\u003e\n\u003cp\u003e\u003ca name=\"OLE_LINK10\"/\u003e7. Chen X, Miao H, Naidu RK, Wang X, Zhou X. Comparison of early changes in and factors affecting vault following posterior chamber phakic Implantable Collamer Lens implantation without and with a central hole (ICL V4 and ICL V4c). BMC Ophthalmol. 2016;16(1):161. doi:10.1186/s12886-016-0336-8.\u003c/p\u003e\n\u003cp\u003e8. Yaşa D, Ürdem U, Ağca A, Yildirim Y, Kepez YB, Kandemir BN, et al. Early Results with a New Posterior Chamber Phakic Intraocular Lens in Patients with High Myopia. J Ophthalmol. 2018;2018:1329874. doi:10.1155/2018/1329874.\u003c/p\u003e\n\u003cp\u003e9. Fernandes P, González-Méijome JM, Madrid-Costa D, Ferrer-Blasco T, Jorge J, Montés-Micó R. Implantable collamer posterior chamber intraocular lenses: a review of potential complications. J Refract Surg. 2011;27(10):765-76. doi:10.3928/1081597X-20110617-01.\u003c/p\u003e\n\u003cp\u003e10. Alfonso JF, Lisa C, Abdelhamid A, Fernandes P, Jorge J, Montés-Micó R. Three-year follow-up of subjective vault following myopic implantable collamer lens implantation. Graefes Arch Clin Exp Ophthalmol. 2010;248(12):1827-35. doi:10.1007/s00417-010-1322-0.\u003c/p\u003e\n\u003cp\u003e11. Lee DH, Choi SH, Chung ES, Chung TY. Correlation between preoperative biometry and posterior chamber phakic Visian Implantable Collamer Lens vaulting. Ophthalmology. 2012;119(2):272-7. doi:10.1016/j.ophtha.2011.07.047.\u003c/p\u003e\n\u003cp\u003e12. Eppig T, Spira C, Tsintarakis T, El-Husseiny M, Cayless A, Müller M, et al. Ghost-image analysis in phakic intraocular lenses with central hole as a potential cause of dysphotopsia. J Cataract Refract Surg. 2015;41(11):2552-9. doi:10.1016/j.jcrs.2015.05.034.\u003c/p\u003e\n\u003cp\u003e13. McGhee CN, Craig JP, Sachdev N, Weed KH, Brown AD. Functional, psychological, and satisfaction outcomes of laser in situ keratomileusis for high myopia. J Cataract Refract Surg. 2000;26(4):497-509. \u003c/p\u003e\n\u003cp\u003e14. Liu T, Linghu S, Pan L, Shi R. Effects of V4c-ICL Implantation on Myopic Patients' Vision-Related Daily Activities. J Ophthalmol. 2016;2016:5717932. doi:10.1155/2016/5717932.\u003c/p\u003e\n\u003cp\u003e15. Badmus SA, Ajaiyeoba AI, Adegbehingbe BO, Onakpoya OH, Adeoye AO. Axial length/corneal radius of curvature ratio and refractive status in an adult Nigerian population. Niger J Clin Pract. 2017;20(10):1328-34. doi:10.4103/njcp.njcp_183_16.\u003c/p\u003e\n\u003cp\u003e16. Goukon H, Kamiya K, Shimizu K, Igarashi A. Comparison of corneal endothelial cell density and morphology after posterior chamber phakic intraocular lens implantation with and without a central hole. Br J Ophthalmol. 2017;101(11):1461-5. doi:10.1136/bjophthalmol-2016-309363.\u003c/p\u003e\n\u003cp\u003e17. Kojima T, Maeda M, Yoshida Y, Ito M, Nakamura T, Hara S, et al. Posterior chamber phakic implantable collamer lens: changes in vault during 1 year. J Refract Surg. 2010;26(5):327-32. doi:10.3928/1081597X-20090617-11.\u003c/p\u003e\n\u003cp\u003e18. Lee H, Kang DS, Ha BJ, Choi M, Kim EK, Seo KY, et al. Effect of Accommodation on Vaulting and Movement of Posterior Chamber Phakic Lenses in Eyes With Implantable Collamer Lenses. Am J Ophthalmol. 2015;160(4):710-6.e1. doi:10.1016/j.ajo.2015.07.014.\u003c/p\u003e\n\u003cp\u003e19. Kothari KJ, Nayak PR, Mehta BK. Pseudophakic hyperopia in nanophthalmic eyes managed by a posterior chamber implantable collamer lens. Indian J Ophthalmol. 2011;59(2):165-6. doi:10.4103/0301-4738.77014.\u003c/p\u003e\n\u003cp\u003e20. Ferrer-Blasco T, García-Lázaro S, Belda-Salmerón L, Albarrán-Diego C, Montés-Micó R. Intra-eye visual function comparison with and without a central hole contact lens-based system: potential applications to ICL design. J Refract Surg. 2013;29(10):702-7. doi:10.3928/1081597X-20130919-03.\u003c/p\u003e\n\u003cp\u003e21. Pérez-Vives C, Domínguez-Vicent A, Ferrer-Blasco T, Madrid-Costa D, Montés-Micó R. Optical quality of hyperopic and myopic phakic intraocular lenses. Indian J Ophthalmol. 2014;62(4):437-41. doi:10.4103/0301-4738.119423.\u003c/p\u003e\n\u003cp\u003e\u003ca name=\"_GoBack\"/\u003e22. Pérez-Vives C, Ferrer-Blasco T, Madrid-Costa D, García-Lázaro S, Montés-Micó R. Visual quality comparison of conventional and Hole-Visian implantable collamer lens at different degrees of decentering. Br J Ophthalmol. 2014;98(1):59-64. doi:10.1136/bjophthalmol-2013-303787.\u003c/p\u003e"},{"header":"Tables","content":"\u003cp class=table align=left style='margin-top:7.8pt;margin-right:0in;\nmargin-bottom:7.8pt;margin-left:0in;text-align:left;line-height:105%;\ntext-autospace:none'\u003e\u003cb\u003e\u003cspan style='font-size:12.0pt;line-height:105%;\nfont-family:\"Times New Roman\",serif;color:black;background:white'\u003e\u0026nbsp;\u003c/span\u003e\u003c/b\u003e\u003c/p\u003e\n\n\u003ctable class=MsoNormalTable border=0 cellspacing=0 cellpadding=0 width=695\n style='margin-left:-25.4pt;border-collapse:collapse'\u003e\n \u003ctr\u003e\n \u003ctd width=695 valign=top style='width:521.55pt;border-top:solid black 1.0pt;\n border-left:none;border-bottom:solid black 1.0pt;border-right:none;\n padding:0in 0in 0in 0in'\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003eVisual Mean score Very % Positive% Negative%\n Very \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003efunctions ±SD positive \n negative % \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003e 6m / 24m \u003c/span\u003e\u003cspan\n style='font-size:15.0pt;line-height:107%;font-family:\"Times New Roman\",serif;\n color:black'\u003e \u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=695 valign=top style='width:521.55pt;border:none;border-bottom:\n solid black 1.0pt;padding:0in 0in 0in 0in'\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003eReading in daylight 8.7±0.77 / 8.8±0.8 72.3 /\n 73.1 27.7/ 26.9 0 0 \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003e \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003eReading in artificial light 8.7±0.76 / 8.9±0.7 74.2 /\n 76.8 25.8/ 23.2 0 0 \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003e \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003eWatching TV 8.9±0.81 / 9.0±0.78 77.4 / 77.2 \n 22.6/ 22.8 0 0 \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003e \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003eWatching movie at cinema 8.8±0.72 / 8.8±0.6 80.0 /\n 81.9 20.0/18.1 0 0 \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003e \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003eDriving in daylight 8.7±0.82 / 8.7±0.7 77.5 / 76.9 22.5/23.1 \n 0 0 \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003e \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003eDriving at night 8.0±0.79 / 8.2±0.9 55.2 / 52.6 \n 38.8/37.4 6/10 0 \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003e \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003eReading computer 8.0±0.69 / 8.3±0.5 55.9 / 55.5 \n 44.1/44.5 0 0 \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003escreen \n \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003ePlaying sports 8.8±0.81 / 8.8±0.8 77.2 / 77.6 \n 22.8/22.4 0 0 \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003e \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003eSwimming 8.5±0.67 / 8.8±0.7 74.5 / 73.6 \n 22.5/23.1 0 0 \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003e \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003eShaving/makeup 8.6±0.91 / 8.8±0.7 81.4 / 82.3 \n 18.6/17.7 0 0 \u003c/span\u003e\u003c/p\u003e\n \u003cp class=table style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003e \n \u003c/span\u003e\u003c/p\u003e\n \u003cp class=MsoNormal style='text-autospace:none'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;\n color:black'\u003eShopping 8.9±0.74 / 9.0 ±0.6 82.9 / 81.2 \n 17.1/18.8 0 0 \u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003c/p\u003e\n\u003cp\u003e\u003c/p\u003e\n\u003cp\u003e Table 1: The visual function questionnaire for all 23 patients after ICL implantation\nNote: the score is 10 points, which stated that 7.5-10.0 is very satisfied, 5.0-7.5 is satisfied; 2.5-5.0 points is negative; 0-2.5 is very negative.\n\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Implantable Collamer Lens, vision related daily activities, long-term safety and efficacy","lastPublishedDoi":"10.21203/rs.2.79/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.2.79/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: The purpose of the study was to evaluate long-term quality of visual related daily activities after Central Hole Collamer Lens implantation to treat myopia and myopic astigmatism.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: This retrospective study included 46 eyes (23 patients) receiving an ICL-V4c implantation. The follow up time was at least 24 m. Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction, eye axis, intraocular pressure, endothelial cell density (ECD), vault, and the patients’ satisfaction related to vision related daily activities were recorded at 6 m and 24 m.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e The mean spherical equivalents were -0.14 ± 0.21 D and -0.12 ± 0.33 D at 6 m and 24 m after surgery, respectively. UCVA of all eyes were equal to or better than preoperative BCVA. The BCVA at 6 m and 24 m after implantation were -0.03 ± 0.08 LogMAR, and −0.03 ± 0.11 LogMAR, respectively, which was statistically better (\u003cem\u003eP\u003c/em\u003e = 0.031) than that of pre-operation value of 0.07 ± 0.12 LogMAR. There was no significant differences (\u003cem\u003eP\u003c/em\u003e \u0026gt; 0.05) between the pre operation and post operation ECD.At 24 m post operation, 10% of the patients complained of difficulty driving at night, but most of patient had satisfactory or very satisfactory vision-related daily activity scores. Some patients, 13%, were worried about the long-term safety and efficacy of the V4c-ICL implantation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e: Patients were very satisfied with their vision related daily activities after V4c-ICL implantation. With time, some patients worried about the permanent safety and efficacy.\u0026nbsp;\u003c/p\u003e","manuscriptTitle":"Long Term Assessment of the Quality of Visual-related Daily Activities after ICL (V4C) Implantation for Myopia and Myopic Astigmatism","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2018-12-13 02:55:29","doi":"10.21203/rs.2.79/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"96c1262c-35d1-40e1-b4b7-b44151a7786c","owner":[],"postedDate":"December 13th, 2018","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":197,"name":"Internal Medicine Specialties"}],"tags":[],"updatedAt":"","versionOfRecord":[],"versionCreatedAt":"2018-12-13 02:55:29","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-79","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"identity":"rs-79","version":["v1"]},"buildId":"_2-kVJe1T_tPrBINL-cwx","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}