title: Traumatic cataract and other adverse events with the implantable contact lens.
abstract: OBJECTIVE
  To evaluate the surgical outcome and adverse events associated with implantation of the implantable contact lens (ICL) for the correction of high myopia or high hyperopia.
  
  
  METHODS
  Helsinki University Eye Hospital, Helsinki, Finland.
  
  
  METHODS
  In this nonrandomized prospective clinical trial, the ICL V4 was implanted in 26 eyes of 13 patients with normal enrollment criteria (younger than 45 years, a clinically clear crystalline lens) (Group 1) and the V2, V3, or V4 were implanted in 38 eyes of 22 patients with heterogeneous criteria (older than 45 years or opacities in the crystalline lens) (Group 2). The main outcome measures were lens opacity classification system (LOCS II) assessment and transparency analysis of the lens.
  
  
  RESULTS
  In Group 1, microdensitometric assessment showed no decrease in crystalline lens transparency and no statistically significant increase in crystalline lens density at any follow-up examination (P>.05). The incidence of anterior subcapsular (AS) opacities was 7.7%, and no eye developed clinically significant cataract during the mean follow-up of 13.2 months +/- 12.3 (SD). No myopic eye lost a line of best corrected visual acuity (BCVA); 50.0% of hyperopic eyes lost 1 line of BCVA. Sixty-eight percent of myopic eyes and 75.0% of hyperopic eyes were within +/-1.0 diopter of the predicted refraction. In Group 2, the incidence of AS opacities was 47.4% and 10 eyes (26.3%) developed clinically significant cataract during the mean follow-up of 30.9 +/- 18.0 months. The visual and refractive results were similar to those in Group 1 at 1 month, but due to progressive AS opacities in the crystalline lens, 23.4% of eyes lost BCVA lines during the follow-up. Intraoperative complications were few and insignificant.
  
  
  CONCLUSIONS
  Implantation of the ICL for correction of high myopia or high hyperopia appears to be a safe procedure with good visual and refractive results immediately. There was no decrease in the transparency or increase in the density of the crystalline lens with the latest generation of the ICL device in the normal group, indicating enhanced safety. Progressive lens opacification in the heterogeneous group shows there are risk factors for cataract formation; ie, type V3 ICL, preexisting lens opacities, and older patient age. Anterior subcapsular opacities are most likely the result of trauma.
authors.affiliation: Helsinki University Eye Hospital, Helsinki, Finland.
authors.forename: Anna-Ulrika
authors.initials: AU
authors.lastname: Sarikkola
authors.forename: H Nida
authors.initials: HN
authors.lastname: Sen
authors.forename: Risto J
authors.initials: RJ
authors.lastname: Uusitalo
authors.forename: Leila
authors.initials: L
authors.lastname: Laatikainen
mesh_terms: D000328:Adult; D002386:Cataract / Q000175:diagnosis / Q000209:etiology*; D003261:Contact Lenses / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006956:Hyperopia / Q000601:surgery*; D007429:Intraocular Pressure; D007431:Intraoperative Complications; D019654:Lens Implantation, Intraocular / Q000009:adverse effects*; D007908:Lens, Crystalline / Q000293:injuries* / Q000473:pathology; D007910:Lenses, Intraocular / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000601:surgery*; D011183:Postoperative Complications; D011446:Prospective Studies; D012029:Refraction, Ocular; D012307:Risk Factors; D014792:Visual Acuity