title: United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up.
abstract: OBJECTIVE
  To report on 3-year postoperative safety and efficacy outcomes with the Myopic Implantable Collamer Lens (ICL).
  
  
  METHODS
  Prospective nonrandomized clinical trial.
  
  
  METHODS
  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.
  
  
  METHODS
  Implantation of the ICL.
  
  
  METHODS
  Uncorrected visual acuity (VA), refraction, best spectacle-corrected VA (BSCVA), adverse events, operative and postoperative complications, lens opacity analysis, subjective satisfaction, and patient symptoms.
  
  
  RESULTS
  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) were seen in 14 eyes (2.7%), with only 2 being clinically significant. Five eyes (0.9%) of 3 patients developed nuclear opacities of grade >2 at 2 to 3 years postoperatively. Three (0.6%) ICL removals with cataract extraction and IOL implantation have been performed. Only 0.6% reported dissatisfaction; 97.1% of patients reported they would choose ICL implantation again. Incidences of patient symptoms, glare, halos, double vision, night vision problems, and night driving difficulties decreased or remained unchanged after ICL surgery.
  
  
  CONCLUSIONS
  Three-year results from this standardized, multicenter clinical investigation support the safety, efficacy, and predictability of ICL surgery to treat moderate to high myopic refractive errors.
authors.affiliation: Center for Clinical Research, Chicago, Illinois, USA.
authors.forename: Donald R
authors.initials: DR
authors.lastname: Sanders
authors.forename: Kimberley
authors.initials: K
authors.lastname: Doney
authors.forename: Monica
authors.initials: M
authors.lastname: Poco
mesh_terms: D000328:Adult; D000867:Anterior Chamber / Q000601:surgery*; D002452:Cell Count; D003261:Contact Lenses; D015350:Contrast Sensitivity / Q000502:physiology; D004728:Endothelium, Corneal / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000503:physiopathology / Q000601:surgery*; D017060:Patient Satisfaction; D011183:Postoperative Complications; D011446:Prospective Studies; D011474:Prosthesis Design; D019919:Prosthesis Implantation; D012449:Safety; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D014792:Visual Acuity / Q000502:physiology