Leukoma Clinical Trial
Official title:
A Prospective, Randomized, Open Label Clinical Trial to Evaluate the Safety and Effectiveness of the RHCIII-MPC Biosynthetic Cornea Compared to Human Cornea in Patients Requiring Anterior Lamellar Keratoplasty
In this study safety and effectiveness of bioengineered cornea comprising of interpenetrating networks of recombinant human type III collagen and synthetic phospholipid - phosphorylcholine - will be tested in patients with corneal scars (leukomas) after infection, trauma or keratoconus. Control group will consist of patients with the same condition who will undergo corneal transplantation - current standard of care.
Recently developed and passed extensive pre-clinical testing
collagen-phosphorylcholine(RHCIII-MPC) corneal substitute will be implanted in patient's
corneas with corneal scar (leukoma) developed after infection, trauma or keratoconus using
anterior lamellar keratoplasty technique, i.e. once patient's diseased anterior part of
cornea is removed, either manually or with assistance of femtosecond laser, it will be
substituted with proposed transparent implant. Control patients with same condition will be
grafted with human donor cornea using the same surgical technique.
The investigators will test the safety and the effectiveness of developed biosynthetic
corneas. Overall 20 patients are planned to recruit. They will be randomized in two groups -
10 patients will undergo RHCIII-MPC cornea implantation, another 10 will be impanted with
human donor cornea. The patients will be follow-uped for 12 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02277054 -
Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty
|
N/A |