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      Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study

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          Abstract

          Purpose

          To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL) (enVista® MX60; Bausch and Lomb Incorporated, Rochester, NY, USA) following implantation to correct aphakia subsequent to extracapsular cataract extraction in adults.

          Subjects and methods

          This was an open-label, non-interventional, observational study conducted in 19 university and private-practice settings in Europe and the Asia-Pacific region to investigate clinical outcomes of the MX60 IOL in standard practice. Eligible subjects were at least 18 years of age and had undergone standard phacoemulsification and extracapsular cataract extraction with implantation of the MX60 IOL. The primary safety endpoint was the occurrence of adverse events, and the primary effectiveness endpoints included visual and refractive outcomes and stability, with data collected up to 2 years post-procedure.

          Results

          In this multicenter study, pooled data of 255 eyes were collected and analyzed. Excellent visual and refractive outcomes and stability were demonstrated. At postoperative visit 4 (61–180 days postoperative), 62.2% of subjects achieved a Snellen best-corrected distance visual acuity (CDVA) of 20/20 (decimal 1.00), and 97.8% of subjects achieved a CDVA of 20/40 (decimal 0.50) or better. One eye (1.0%) underwent neodymium:yttrium aluminum garnet capsulotomy at 12 months post-procedure. No glistenings of any grade were reported for any subject at any visit. Adverse events were infrequent and were consistent with incidences generally reported with cataract surgery.

          Conclusion

          This study, which enrolled all comers, provided evidence of the excellent safety and effectiveness of the MX60 IOL in standard practice. Favorable clinical outcomes included outstanding visual and refractive outcomes and stability. No glistenings were reported at any postoperative visit.

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          Most cited references26

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          The International Conference on Harmonization Good Clinical Practice guideline.

          The purposes of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline are to protect the rights of human subjects participating in clinical trials and to ensure the scientific validity and credibility of the data collected in human clinical studies. The guiding principle in the guideline is that the rights, safety, and well-being of the trial subject are the most important considerations and should prevail over the interests of science and society. The guideline will have an important and beneficial impact on the clinical trials conducted in the three participating regions (the United States, Europe, and Japan) as well as many other regions throughout the world. In the years to come, it should fulfill its intended purpose of providing for a more economical use of human, animal, and material resources and the elimination of unnecessary delays in the global development and availability of new medicines, and at the same time maintaining safeguards on quality, safety, and efficacy and regulatory obligations to protect public health.
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            Cystoid macular edema, retinal detachment, and glaucoma after Nd:YAG laser posterior capsulotomy.

            A series of 897 Nd:YAG laser posterior capsulotomies were reviewed for the complications of cystoid macular edema, retinal detachment, new onset of glaucoma, and worsened preexisting glaucoma. After Nd:YAG capsulotomy, 11 patients (1.23%; 95% confidence interval, 0.51% to 1.95%) developed cystoid macular edema and eight patients (0.89%; 95% confidence interval, 0.28% to 1.5%) developed a retinal detachment. The new onset of glaucoma was observed in seven patients (0.78%; 95% confidence interval, 0.20% to 1.36%). Five patients (0.56%; 95% confidence interval, 0.07% to 1.05%) with preexisting glaucoma had persistent worsening of their glaucoma. Most patients with a complication had no identifiable risk factors in common. The numbers of laser pulses and energy delivered were not risk factors. Retinal detachment and cystoid macular edema developed most often many months after capsulotomy and many months to years after the cataract surgery. Patients undergoing Nd:YAG laser capsulotomy therefore require ongoing medical observation to detect and treat these serious complications.
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              Glistenings and surface light scattering in intraocular lenses.

              Glistenings are fluid-filled microvacuoles that form within the intraocular lens (IOL) optic when the IOL is in an aqueous environment. They are observed in all types of IOLs but have been mainly associated with hydrophobic acrylic IOLs. Experimental and clinical studies suggest the various hydrophobic acrylic IOLs on the market exhibit different tendencies toward glistenings. Factors influencing glistening formation include IOL material composition, manufacturing technique, packaging, associated conditions such as glaucoma or those leading to breakdown of the blood-aqueous barrier, as well as concurrent use of ocular medications. Although the impact of glistenings on postoperative visual function and the evolution of glistenings in the late postoperative period remain controversial, IOL explantation has rarely been reported. The phenomenon of surface light scattering has also been described in association with hydrophobic acrylic IOLs. Its mechanism of formation is controversial but may be related to long-term phase separation water near the IOL surface, although not seen as microvacuoles. The author has no financial or proprietary interest in any material or method mentioned. Copyright 2010 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                Clin Ophthalmol
                Clin Ophthalmol
                Clinical Ophthalmology
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove Medical Press
                1177-5467
                1177-5483
                2014
                27 March 2014
                : 8
                : 629-635
                Affiliations
                [1 ]Vision Eye Institute, Southport, QLD, Australia
                [2 ]Ophthalmic Center, San Siro Clinic, Milan, Italy
                [3 ]Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
                Author notes
                Correspondence: Peter Heiner, Vision Eye Institute, Level 4, 2 Short Street, Southport, QLD 4215, Australia, Tel +61 7 5557 8300, Fax +61 7 5562 0772, Email pheiner77@ 123456hotmail.com
                Article
                opth-8-629
                10.2147/OPTH.S56135
                3974695
                24729678
                5fad1466-0091-4753-8771-2704651385f5
                © 2014 Heiner et al. This work is published by Dove Medical Press Ltd, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Ltd, provided the work is properly attributed.

                History
                Categories
                Original Research

                Ophthalmology & Optometry
                cataract surgery,glistenings,iol,mx60
                Ophthalmology & Optometry
                cataract surgery, glistenings, iol, mx60

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