title: The Chirila Keratoprosthesis: phase I human clinical trial.
abstract: OBJECTIVE
  To undertake a preliminary safety and performance evaluation of an artificial cornea, the Chirila Keratoprosthesis, in human patients.
  
  
  METHODS
  A prospective, interventional case series.
  
  
  METHODS
  Fourteen consecutive patients with blindness of corneal origin not treatable by repeated standard penetrating keratoplasty.
  
  
  METHODS
  Keratoprostheses were manufactured and implanted. The patients, all with preoperative visual acuity of light perception to count fingers (CF), were followed clinically in adherence to a protocol.
  
  
  METHODS
  Safety (keratoprosthesis retention, incidence of serious complications) and performance (visual acuity, comfort, appearance).
  
  
  RESULTS
  Ninety-three percent of keratoprostheses were retained to the date of reporting, up to 2.5 years. One keratoprosthesis (7%) was removed in a manner that restored the patient's preoperative condition. All but one patient maintained their preoperative level of visual acuity or improved on it, with most achieving their estimated full potential visual acuity, (range, count fingers - 20/20).
  
  
  CONCLUSIONS
  This keratoprosthesis is acceptably safe and has demonstrated an ability to restore vision in cases in which alternative management would have had a poor prognosis. More extensive trials are warranted.
authors: Lions Eye Institute and Centre for Ophthalmology and Visual Science, University of Western Australia, Perth, Australia.
authors: Geoffrey J
authors: GJ
authors: Crawford
authors: Celia R
authors: CR
authors: Hicks
authors: Xia
authors: X
authors: Lou
authors: Sarojini
authors: S
authors: Vijayasekaran
authors: Donald
authors: D
authors: Tan
authors: Bridget
authors: B
authors: Mulholland
authors: Traian V
authors: TV
authors: Chirila
authors: Ian J
authors: IJ
authors: Constable
mesh_terms: D003315:Cornea; D003318:Corneal Opacity / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D011102:Polyhydroxyethyl Methacrylate; D011446:Prospective Studies; D019736:Prostheses and Implants; D019919:Prosthesis Implantation / Q000379:methods*; D012449:Safety; D014792:Visual Acuity
chemical_list: D011102:Polyhydroxyethyl Methacrylate