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      Two-Year Outcomes of Visian Implantable Collamer Lens with a Central Hole for Correcting High Myopia

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          Abstract

          Purpose

          To investigate two-year outcomes of Visian Implantable Collamer Lens with a central hole (ICL V4c) implantation for correcting high myopia.

          Methods

          Sixty-one eyes of 32 patients went through ICL V4c implantation. Safety, efficacy, predictability, and intraocular pressure were evaluated 2 years postoperatively. Anterior chamber volume (ACV), anterior chamber depth (ACD), anterior chamber angle width (ACAW), and vault were measured using a Scheimpflug tomography imaging system.

          Results

          At 2 years, the spherical equivalent refraction decreased from preoperative −14.62 ± 4.29 D to −0.90 ± 0.95 D, with 79% of the eyes within ±0.50 D and 98% within ±1.00 D of the intended correction. The efficacy index was 1.03 ± 0.23, and the safety index was 1.24 ± 0.26. Corrected distance visual acuity (CDVA) remained unchanged in 23% of the eyes, 75% gained one or more lines of CDVA, and 2% lost one line. The ACV, ACD, and ACAW, respectively, decreased from 193.28 ± 29.15 mm 3, 3.15 ± 0.23 mm, and 36.51 ± 6.54 degree to 112.48 ± 17.01 mm 3, 2.99 ± 0.23 mm, and 22.54 ± 5.27 degree ( p=0.0008, 0.008, and  0.0003, resp.). Intraocular pressure was 15.39 ± 2.88 mmHg before surgery and was 15.86 ± 4.11 mmHg at 2 years ( p=0.11).

          Conclusion

          Implantation of ICL V4c is a safe, effective, and predictable procedure for correcting high myopia. Reduction of anterior chamber space after surgery did not induce intraocular pressure increase during the 2-year follow-up.

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          Most cited references27

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          High prevalence of myopia and high myopia in 5060 Chinese university students in Shanghai.

          Myopia is an important cause of correctable visual impairment worldwide. Genetic and environmental factors contribute to its development. The population of Chinese university students consists of approximately 30 million young people characterized by academic excellence and similar ages. To date, little is known about their refractive status. Our study is designed to investigate the prevalence of myopia in this specific population. This is a cross-sectional study of myopia among university students in Shanghai, China; 5083 students from Donghua University were enrolled. All participants first responded to a detailed questionnaire, including questions on ethnicity, birth date, and family history, and then undertook a standardized ophthalmologic examination, including visual acuity, a slit-lamp examination, and non-cycloplegic autorefraction. The mean spherical equivalent refraction (SER) of the university students was -4.1 diopters (D). Of the subjects 95.5% were myopic (SER < -0.50 D), 19.5% were highly myopic (SER < -6.0 D), and only 3.3% were emmetropic (-0.5 D ≤ SER ≤ 0.5 D). The postgraduates were more myopic than the undergraduates (96.9% and 94.9%, respectively). Being female (-4.1 ± 2.4 D in female versus -3.8 ± 2.4 D in male subjects), of Han ethnicity (-4.1 ± 2.4 D in Han versus -3.4 ± 2.2 D in minorities), and of older age were associated with a higher probability of myopia only in the undergraduate population. The prevalence of myopia and high myopia in this university student population was high. The refractive status of this population deserves further attention.
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            Early clinical outcomes of implantation of posterior chamber phakic intraocular lens with a central hole (Hole ICL) for moderate to high myopia.

            To assess the early clinical outcomes of an ICL with a central hole (Hole ICL) implantation for the correction of moderate to high myopia.
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              Long-Term Comparison of Posterior Chamber Phakic Intraocular Lens With and Without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism

              Abstract The study shows a promising next-generation surgical option for the correction of moderate to high ametropia. Hole implantable collamer lens (ICL), STAAR Surgical, is a posterior chamber phakic intraocular lens with a central artificial hole. As yet, however, no long-term comparison of the clinical results of the implantation of ICLs with and without such a hole has hitherto been conducted. A prospective, randomized, controlled trial was carried out in order to compare the long-term clinical outcomes of the implantation, in such eyes, of ICLs with and without a central artificial hole. Examinations were conducted of the 64 eyes of 32 consecutive patients with spherical equivalents of −7.53 ± 2.39 diopters (D) (mean ± standard deviation) in whom implantation of a Hole ICL was performed in 1 eye, and that of a conventional ICL was carried out in the other, by randomized assignment. Before 1, 3, and 6 months, and 1, 3, and 5 years after surgery, the safety, efficacy, predictability, stability, intraocular pressure, endothelial cell density, and adverse events of the 2 surgical techniques were assessed and compared over time. The measurements of LogMAR uncorrected and corrected distance visual acuity 5 years postoperatively were −0.17 ± 0.14 and −0.24 ± 0.08 in the Hole ICL group, and −0.16 ± 0.10 and −0.25 ± 0.08 in the conventional ICL group. In these 2 groups, 96% and 100% of eyes, respectively, were within 1.0 D of the targeted correction 5 years postoperatively. Manifest refraction changed by −0.17 ± 0.41 D and −0.10 ± 0.26 D occurred in from 1 month to 5 years in the Hole and conventional ICL groups, respectively. Only 1 eye (3.1%), which was in the conventional ICL group, developed an asymptomatic anterior subcapsular cataract. Both Hole and conventional ICLs corrected of ametropia successfully throughout the 5-year observation period. It appears likely that the presence of the central hole does not significantly affect these visual and refractive outcomes. Trial Registration: UMIN000018771.
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                Author and article information

                Contributors
                Journal
                J Ophthalmol
                J Ophthalmol
                JOPH
                Journal of Ophthalmology
                Hindawi
                2090-004X
                2090-0058
                2018
                3 July 2018
                : 2018
                : 8678352
                Affiliations
                1Department of Ophthalmology, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
                2Department of Ophthalmology and Optometry, Eye and ENT Hospital, Fudan University, Shanghai, China
                3NHC Key Laboratory of Myopia, Fudan University, Shanghai, China
                4Shanghai Research Center of Ophthalmology and Optometry, Shanghai, China
                Author notes

                Academic Editor: Tamer A. Macky

                Author information
                http://orcid.org/0000-0002-0337-2710
                http://orcid.org/0000-0002-5126-7683
                http://orcid.org/0000-0002-3465-1579
                Article
                10.1155/2018/8678352
                6051026
                30057804
                99e4729a-2cfc-4c5f-b2fe-8fce852f1022
                Copyright © 2018 Zhipeng Yan et al.

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 4 February 2018
                : 21 May 2018
                : 30 May 2018
                Funding
                Funded by: Project of Shanghai Science and Technology
                Award ID: 17140902900
                Award ID: 17411950200
                Funded by: Natural Science Foundation of China for Young Scholars
                Award ID: 81700872
                Award ID: 81500753
                Funded by: Shanghai Shenkang Hospital Development Center
                Award ID: SHDC12016207
                Funded by: National Natural Science Foundation of China
                Award ID: 81770955
                Award ID: 81570879
                Categories
                Clinical Study

                Ophthalmology & Optometry
                Ophthalmology & Optometry

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