United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up

Ophthalmology
Donald R SandersICL in Treatment of Myopia Study Group

Abstract

To report on 3-year postoperative safety and efficacy outcomes with the Myopic Implantable Collamer Lens (ICL). Prospective nonrandomized clinical trial. Five hundred twenty-six eyes of 294 patients with between 3.0 and 20.0 diopters (D) of myopia participating in the United States Food and Drug Administration clinical trial of the ICL for myopia. Implantation of the ICL. Uncorrected visual acuity (VA), refraction, best spectacle-corrected VA (BSCVA), adverse events, operative and postoperative complications, lens opacity analysis, subjective satisfaction, and patient symptoms. At 3 years, 59.3% had 20/20 or better VA, and 94.7% had 20/40 or better uncorrected VA if BSCVA was 20/20 and patients were targeted for emmetropia; 67.5% of patients were within 0.5 D and 88.2% were within 1.0 D of predicted refraction. The mean improvement in BSCVA ranged between 0.5 and 0.6 lines. At 3 years postoperatively, 3 eyes (0.8%) decreased by >or=2 lines of BSCVA, in contrast to 40 eyes (10.8%) that improved by a similar amount. Contrast sensitivity improved postoperatively. Cumulative 3-year corneal endothelial cell loss was under 10%. Early largely asymptomatic, presumably surgically induced anterior subcapsular opacities (trace or greater)...Continue Reading

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Citations

Feb 27, 2008·Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Für Klinische Und Experimentelle Ophthalmologie·Tetsu ShirataniYuuki Murakami
Sep 25, 2012·Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Für Klinische Und Experimentelle Ophthalmologie·J F AlfonsoR Montés Micó
Oct 12, 2012·Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Für Klinische Und Experimentelle Ophthalmologie·Esin Sogutlu SariYusuf Ozerturk
Nov 13, 2012·Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Für Klinische Und Experimentelle Ophthalmologie·Cari Pérez-VivesRobert Montés-Micó
Aug 12, 2008·American Journal of Ophthalmology·Kazutaka KamiyaHitoshi Ishikawa
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Nov 20, 2013·The British Journal of Ophthalmology·Cari Pérez-VivesRobert Montés-Micó
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Mar 25, 2010·Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Für Klinische Und Experimentelle Ophthalmologie·José F AlfonsoRobert Montés-Micó
Oct 19, 2010·Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Für Klinische Und Experimentelle Ophthalmologie·Kazutaka KamiyaKazuo Ichikawa
Mar 1, 2012·Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Für Klinische Und Experimentelle Ophthalmologie·Jose F AlfonsoR Montés-Micó
May 15, 2010·Current Opinion in Ophthalmology·Jocelyn Kuryan, Prabjot Channa
Jul 14, 2012·Journal of Cataract and Refractive Surgery·Rohini PothireddyHarsha L Rao
Jun 28, 2011·Journal of Cataract and Refractive Surgery·Stephen S Lane, Curtis Waycaster
Apr 23, 2011·Journal of Cataract and Refractive Surgery·José F AlfonsoRobert Montés-Micó
Oct 30, 2010·Journal of Cataract and Refractive Surgery·Jose Luis GüellThomas Kohnen
Nov 30, 2010·Journal of Cataract and Refractive Surgery·Thomas KohnenJose Luis Güell
Sep 28, 2010·Journal of Cataract and Refractive Surgery·Yousuf M KhalifaLiliana Werner
Jul 27, 2010·Journal of Cataract and Refractive Surgery·José F AlfonsoRobert Montés-Micó
Aug 3, 2010·Journal of Cataract and Refractive Surgery·Brian S Boxer Wachler, Lorelei L Vicente
May 25, 2010·Journal of Cataract and Refractive Surgery·José F AlfonsoRobert Montés-Micó
Apr 7, 2010·Journal of Cataract and Refractive Surgery·José F AlfonsoRobert Montés-Micó
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Dec 9, 2009·Journal of Cataract and Refractive Surgery·Levent AkcayOmer Kamil Dogan
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