title: Clinical outcomes after implantation of a posterior chamber collagen copolymer phakic intraocular lens with a central hole for myopic correction.
abstract: OBJECTIVE
  To evaluate the efficacy, predictability, safety, and stability of a new-model posterior chamber Implantable Collamer Lens phakic intraocular lens (pIOL) (V4c Visian) to correct myopia.
  
  
  METHODS
  Private practice, Oviedo, Spain.
  
  
  METHODS
  Case series.
  
  
  METHODS
  This study enrolled patients who had implantation of a new pIOL design with a central hole for more natural aqueous flow, eliminating the need for neodymium:YAG iridotomy or peripheral iridectomy. The uncorrected (UDVA) and corrected (CDVA) distance visual acuities, refractive error, intraocular pressure (IOP), endothelial cell count, central vault, and adverse events were evaluated 6 months postoperatively.
  
  
  RESULTS
  The study enrolled 138 eyes (70 patients). The mean spherical equivalent decreased from -8.73 diopters (D) ± 2.54 (SD) preoperatively to -0.03 ± 0.19 D 6 months postoperatively; 98.5% of eyes were within ±0.50 D and 100% of eyes were within ±1.00 D. The mean UDVA and CDVA were 20/20 or better in 92.1% and 95.0% of eyes, respectively, at 6 months. The safety and efficacy indices were 1.01 and 1.00, respectively. Postoperatively, the IOP remained stable over time. No significant rises in IOP (including pupillary block) and no secondary cataract were found. After 6 months, the mean vault was 482.7 ± 210.5 μm (range 90 to 970 μm) and the mean endothelial cell loss was 8.5%.
  
  
  CONCLUSIONS
  Implantation of the pIOL was effective, predictable, safe, and stable for the correction of moderate to high myopic errors. This design, which avoids iridotomy or iridectomy, provided good IOP outcomes.
  
  
  BACKGROUND
  No author has a financial or proprietary interest in any material or method mentioned.
authors.affiliation: Fernández-Vega Ophthalmological Institute, School of Medicine, University of Oviedo, Oviedo, Spain. j.alfonso@fernandez-vega.com
authors.forename: José F
authors.initials: JF
authors.lastname: Alfonso
authors.forename: Carlos
authors.initials: C
authors.lastname: Lisa
authors.forename: Luis
authors.initials: L
authors.lastname: Fernández-Vega Cueto
authors.forename: Lurdes
authors.initials: L
authors.lastname: Belda-Salmerón
authors.forename: David
authors.initials: D
authors.lastname: Madrid-Costa
authors.forename: Robert
authors.initials: R
authors.lastname: Montés-Micó
mesh_terms: D000328:Adult; D002452:Cell Count; D003094:Collagen / Q000737:chemistry*; D055954:Corneal Endothelial Cell Loss / Q000175:diagnosis; D004728:Endothelium, Corneal / Q000473:pathology; 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; D011446:Prospective Studies; D011474:Prosthesis Design; D012030:Refractive Errors / Q000503:physiopathology; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
chemical_list: D003094:Collagen