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.


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.
Crawford
Geoffrey J
GJ
Lions Eye Institute and Centre for Ophthalmology and Visual Science, University of Western Australia, Perth, Australia.
Hicks
Celia R
CR
Lou
Xia
X
Vijayasekaran
Sarojini
S
Tan
Donald
D
Mulholland
Bridget
B
Chirila
Traian V
TV
Constable
Ian J
IJ
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
D011102:Polyhydroxyethyl Methacrylate