Corneal Ulcer Clinical Trial
Official title:
A Clinical Trial to Evaluate the Safety and Effectiveness of the Collagen-phosphorylcholine Corneal Substitutes in Patients Requiring Lamellar Keratoplasty
In this study the safety and effectiveness of biosynthetic cornea, comprising interpenetrating networks of recombinant human collagen and phosphorylcholine, will be tested in patients with severe corneal pathology (corneal ulcers or corneal opacification from corneal injury, burn or infection) - diseases, where human donor cornea transplantation (the only widely accepted treatment) carries a high risk of rejection.
Collagen-phosphorylcholine corneal substitute will be implanted in patient's corneas with severe pathology (corneal ulcer, corneal leukoma after burn, trauma or infection) using anterior lamellar keratoplasty technique, i.e. when patient's diseased cornea is removed it will be substituted with proposed transparent implant. Usually these patients are grafted with human donor cornea, but the latter frequently fails due to graft-versus-host problems. We will test the safety (incidence of adverse events, biocompatability) and the effectiveness (ability to promote healing and increase vision) of developed biosynthetic corneas in 10 patients with corneal pathology, where human donor cornea carries a high risk of rejection. The patients will be follow-uped for 12 months. ;
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