The Chirila Keratoprosthesis: Phase I human clinical trial

Objective: To undertake a preliminary safety and performance evaluation of an artificial cornea, the Chirila Keratoprosthesis, in human patients. Design. A prospective, interventional case series. Participants: 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. Main Outcome Measures: Safety (kerato prosthesis retention, incidence of serious complications) and performance (visual acuity, comfort, appearance). Results: Ninety-three percent of kerato prostheses 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. Ophthalmology 2002;109:883-889 (C) 2002 by the American Academy of Ophthalmology.