Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty

NACompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

October 31, 2016

Study Completion Date

January 31, 2017

Conditions
Corneal UlcerLeukoma
Interventions
DEVICE

Collagen-MPC cornea

Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection will be created. Trephine diameter will depend on ulcer or leukoma maximal size. Alternatively a femtosecond laser may be used to create the dissection. A collagen-phosphorylcholine cornea 250-500 microns thick and equal or 0.25 mm larger diameter is placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens will be removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.

Trial Locations (1)

65061

The Filatov Institute of Eye Diseases and Tissue Therapy, Odesa

All Listed Sponsors
collaborator

Linkoeping University

OTHER_GOV

lead

The Filatov Institute of Eye Diseases and Tissue Therapy

OTHER

NCT02277054 - Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty | Biotech Hunter | Biotech Hunter