title: Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) - results of a European and Asian-Pacific study.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Vision Eye Institute, Southport, QLD, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Heiner
authors.affiliation: Ophthalmic Center, San Siro Clinic, Milan, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Ligabue
authors.affiliation: Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.
authors.forename: Alex
authors.initials: A
authors.lastname: Fan
authors.affiliation: Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.
authors.forename: Dennis
authors.initials: D
authors.lastname: Lam
keywords: IOL; MX60; cataract surgery; glistenings
references.citation: J Cataract Refract Surg. 2009 Jul;35(7):1234-8
references.pmid: 19545814
references.citation: Am J Ophthalmol. 1991 Oct 15;112(4):373-80
references.pmid: 1928237
references.citation: Ophthalmology. 2001 Mar;108(3):505-18
references.pmid: 11237905
references.citation: J Cataract Refract Surg. 2010 Jun;36(6):929-34
references.pmid: 20494763
references.citation: J Cataract Refract Surg. 2001 Oct;27(10):1611-4
references.pmid: 11687360
references.citation: J Cataract Refract Surg. 2012 Jul;38(7):1140-6
references.pmid: 22727284
references.citation: J Refract Surg. 2007 Sep;23(7):639-48
references.pmid: 17912933
references.citation: J Cataract Refract Surg. 1999 Jan;25(1):72-6
references.pmid: 9888080
references.citation: Graefes Arch Clin Exp Ophthalmol. 2009 Jul;247(7):965-73
references.pmid: 19277694
references.citation: J Cataract Refract Surg. 1996 May;22(4):452-7
references.pmid: 8733849
references.citation: Ophthalmology. 2001 May;108(5):930-5
references.pmid: 11320024
references.citation: J Cataract Refract Surg. 1997 Jan-Feb;23(1):115-21
references.pmid: 9100118
references.citation: J Cataract Refract Surg. 2001 May;27(5):728-33
references.pmid: 11377904
references.citation: Qual Assur. 1998 Apr-Jun;6(2):65-74
references.pmid: 10386329
references.citation: J Cataract Refract Surg. 2009 Jan;35(1):14-7
references.pmid: 19101419
references.citation: J Cataract Refract Surg. 2010 Aug;36(8):1398-420
references.pmid: 20656166
references.citation: Am J Ophthalmol. 2010 Mar;149(3):383-9.e1-2
references.pmid: 20035922
references.citation: Clin Ophthalmol. 2013;7:1905-12
references.pmid: 24109169
references.citation: Ophthalmic Surg Lasers. 2001 Sep-Oct;32(5):375-82
references.pmid: 11563781
references.citation: J Cataract Refract Surg. 2002 Jul;28(7):1211-6
references.pmid: 12106730
references.citation: Am J Ophthalmol. 1989 May 15;107(5):531-6
references.pmid: 2712134