title: AlphaCor: Clinical outcomes.
abstract: OBJECTIVE
  To study the outcomes of AlphaCor implantation.
  
  
  METHODS
  : The AlphaCor artificial cornea is indicated for corneal blindness not treatable by donor grafting. Prospective preoperative and follow-up data were collected. Data were evaluated using SPSS for statistical analysis of outcomes, trends, and associations.
  
  
  RESULTS
  This report includes data returned through February 28, 2006, for all 322 devices implanted, with mean follow-up in situ of 15.5 months and a maximum of 7.4 years. The probability of AlphaCor retention at 6 months and 1 and 2 years for protocol cases was 92%, 80%, and 62%, respectively, and off-label cases were at higher risk (P = 0.010), as were cases not prescribed medroxyprogesterone (MPG; P = 0.001). Currently, the most common complications were stromal melting, fibrous reclosure of the posterior lamellar opening, and white intraoptic deposits, with incidences in 2005 of 11.4%, 5.1%, and 2.6%, respectively. MPG seems to protect against melts, and eyes with a history of herpetic keratitis were not at increased risk. A history of glaucoma or the presence of tubes did not affect device retention. Complications culminated in loss of an eye in 1.3%. Mean preoperative visual acuity (VA) was hand movements. The VA achieved postoperatively (light perception to 20/20) was affected by previous pathology and postoperative course, with a mean improvement of 2 lines.
  
  
  CONCLUSIONS
  AlphaCor provides a treatment option where a donor tissue graft would not succeed in severe corneal conditions, while being reversible to a donor graft in the event of complications for anatomic integrity. Surgical technique and adjunctive therapies are evolving with experience. Continued data collection is important for a fuller understanding of AlphaCor's role.
authors.affiliation: Biomaterials Research Centre, Lions Eye Institute and Centre for Ophthalmology and Visual Science, University of Western Australia, Perth, Australia. crhicks@cyllene.uwa.edu.au
authors.forename: Celia R
authors.initials: CR
authors.lastname: Hicks
authors.forename: Geoffrey J
authors.initials: GJ
authors.lastname: Crawford
authors.forename: John K G
authors.initials: JK
authors.lastname: Dart
authors.forename: Günther
authors.initials: G
authors.lastname: Grabner
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Holland
authors.forename: R Doyle
authors.initials: RD
authors.lastname: Stulting
authors.forename: Donald T
authors.initials: DT
authors.lastname: Tan
authors.forename: Max
authors.initials: M
authors.lastname: Bulsara
mesh_terms: D000328:Adult; D001187:Artificial Organs; D001672:Biocompatible Materials; D003315:Cornea; D003316:Corneal Diseases / Q000601:surgery; D005500:Follow-Up Studies; D006085:Graft Survival; D006801:Humans; D011102:Polyhydroxyethyl Methacrylate; D011183:Postoperative Complications; D011446:Prospective Studies; D019919:Prosthesis Implantation; D014792:Visual Acuity
chemical_list: D001672:Biocompatible Materials; D011102:Polyhydroxyethyl Methacrylate