MULTI-CENTRED CLINICAL EVALUATION OF A NOVEL KERATOPROSTHESIS [ 2001 - 2003 ]

Research Grant

Researchers: Prof Ian Constable (Principal investigator) ,  Celia Hicks ,  Dr Geoffrey Crawford ,  Prof Traian Chirila

Brief description The prosthesis developed by applicants, known also as Chirila keratoprosthesis, is an artificial implantable device designed to replace a diseased cornea or a failed corneal graft, and can be used in patients with no hope for a conventional replacement of the cornea with donor tissue. The device may ultimately find a wider application, as it has the potential to give better visual results than human donor grafts. Even when not rejected, the donor grafts may lead to problematic healing patterns and astigmatism, both limiting the final vision of patients. From the 45 million blind people worldwide, at least 10 million are due to corneal diseases or trauma. The figures released by WHO suggest a doubling of this number by year 2020. Many countries are unable to provide sufficient donor corneas, sometimes for cultural-religious reasons. In developed countries, the replacement with donor tissue is a common procedure, but many patients remain untreated because their prognosis for successful grafting is poor. Figures released in Australia show that long-term success of donor transplantation is unlikely in the patients identified as high-risk recipients. Furthermore, even technically successful cases show disppointing final vision. The significance of the applicants' artificial cornea is that allows high-risk, or otherwise untreatable corneal blind patients, to have their vision restored, and it could ultimately reduce the need for donor corneal tissue. A phase I pilot study has been completed, and Phase II is currently underway with support from NH and MRC. These studies showed that the Chirila KPro is an effective means of reversible replacement of a diseased cornea.The proposed Phase III will evaluate both safety and effectiveness in different categories of patients in comparison with published outcomes of donor grafting, and will establish unequivocally the clinical potential of this prosthesis.

Funding Amount $AUD 515,091.80

Funding Scheme NHMRC Project Grants

Notes Clinical Trial/Large Scale