title: Posterior chamber collagen copolymer phakic intraocular lens with a central hole to correct myopia: One-year follow-up.
abstract: OBJECTIVE
  To assess the predictability, stability, efficacy, and safety of a newly developed posterior chamber phakic intraocular lens (pIOL) (model V4c Visian Implantable Collamer Lens) to correct moderate to high myopia.
  
  
  METHODS
  Fernández-Vega Ophthalmological Institute, Oviedo, Spain.
  
  
  METHODS
  Prospective case series.
  
  
  METHODS
  This study evaluated eyes that had implantation of the new pIOL model with a central hole for myopia correction. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, refraction, intraocular pressure (IOP), endothelial cell density, pIOL vault, and adverse events were evaluated over 12 months.
  
  
  RESULTS
  The study comprised 147 eyes of 80 patients. Preoperatively, the mean spherical equivalent (SE) was -8.80 diopters (D) ± 2.60 (SD). At 12 months, the mean SE was -0.14 ± 0.26 D, with 93.9% of eyes within ±0.50 D of the target and 100% of eyes within ±1.00 D. The mean UDVA and CDVA were 0.028 ± 0.055 logMAR and 0.003 ± 0.013 logMAR, respectively. The efficacy and safety indices were 1.00 and 1.04, respectively. All eyes had unchanged CDVA or gained 1 or more lines during the follow-up. The IOP remained stable over time; no eye developed anterior subcapsular cataract. Twelve months postoperatively, the mean vault was 405.5 ± 184.7 μm (range 100 to 980 μm), and the mean endothelial cell loss was 1.7%.
  
  
  CONCLUSIONS
  The good refractive and visual acuity outcomes and the highly stable IOP values obtained over 12 months support the use of the new pIOL model with a central hole for the correction of moderate to high myopia.
  
  
  BACKGROUND
  No author has a financial or proprietary interest in any material or method mentioned.
authors.affiliation: From Fernández-Vega Ophthalmological Institute (Lisa, Naveiras, Alfonso) and the Surgery Department (Alfonso), School of Medicine, University of Oviedo, Oviedo, the Department of Ophthalmology (Alfonso-Bartolozzi), Clínica Universidad de Navarra, Pamplona, and the Optics Department (Belda-Salmerón, Montés-Micó), Faculty of Physics, University of Valencia, Valencia, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Lisa
authors.affiliation: From Fernández-Vega Ophthalmological Institute (Lisa, Naveiras, Alfonso) and the Surgery Department (Alfonso), School of Medicine, University of Oviedo, Oviedo, the Department of Ophthalmology (Alfonso-Bartolozzi), Clínica Universidad de Navarra, Pamplona, and the Optics Department (Belda-Salmerón, Montés-Micó), Faculty of Physics, University of Valencia, Valencia, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Naveiras
authors.affiliation: From Fernández-Vega Ophthalmological Institute (Lisa, Naveiras, Alfonso) and the Surgery Department (Alfonso), School of Medicine, University of Oviedo, Oviedo, the Department of Ophthalmology (Alfonso-Bartolozzi), Clínica Universidad de Navarra, Pamplona, and the Optics Department (Belda-Salmerón, Montés-Micó), Faculty of Physics, University of Valencia, Valencia, Spain.
authors.forename: Belén
authors.initials: B
authors.lastname: Alfonso-Bartolozzi
authors.affiliation: From Fernández-Vega Ophthalmological Institute (Lisa, Naveiras, Alfonso) and the Surgery Department (Alfonso), School of Medicine, University of Oviedo, Oviedo, the Department of Ophthalmology (Alfonso-Bartolozzi), Clínica Universidad de Navarra, Pamplona, and the Optics Department (Belda-Salmerón, Montés-Micó), Faculty of Physics, University of Valencia, Valencia, Spain.
authors.forename: Lurdes
authors.initials: L
authors.lastname: Belda-Salmerón
authors.affiliation: From Fernández-Vega Ophthalmological Institute (Lisa, Naveiras, Alfonso) and the Surgery Department (Alfonso), School of Medicine, University of Oviedo, Oviedo, the Department of Ophthalmology (Alfonso-Bartolozzi), Clínica Universidad de Navarra, Pamplona, and the Optics Department (Belda-Salmerón, Montés-Micó), Faculty of Physics, University of Valencia, Valencia, Spain.
authors.forename: Robert
authors.initials: R
authors.lastname: Montés-Micó
authors.affiliation: From Fernández-Vega Ophthalmological Institute (Lisa, Naveiras, Alfonso) and the Surgery Department (Alfonso), School of Medicine, University of Oviedo, Oviedo, the Department of Ophthalmology (Alfonso-Bartolozzi), Clínica Universidad de Navarra, Pamplona, and the Optics Department (Belda-Salmerón, Montés-Micó), Faculty of Physics, University of Valencia, Valencia, Spain. Electronic address: j.alfonso@fernandez-vega.com.
authors.forename: José F
authors.initials: JF
authors.lastname: Alfonso
mesh_terms: D000328:Adult; D003094:Collagen; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D019654:Lens Implantation, Intraocular; D008297:Male; D009216:Myopia / Q000503:physiopathology / Q000601:surgery*; D054120:Phakic Intraocular Lenses; D011108:Polymers; D011446:Prospective Studies; D011474:Prosthesis Design; D012029:Refraction, Ocular / Q000502:physiology; D041623:Tomography, Optical Coherence; D014065:Tonometry, Ocular; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
chemical_list: D011108:Polymers; D003094:Collagen