Clinical Trial: Evaluation of Biosynthetic Constructs to Replace Donor Corneas

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional




Official Title: Evaluation of Biosynthetic Constructs as Replacement for Donor Corneas as Graft Material for Corneal Transplantation

Brief Summary: Constructs made from cross-linked Human Recombinant Collagen type III are being used instead of human donor corneas in 6 patients at Deep anterior lamellar cornea grafting. Six patients serve as controls and are receiving human donor corneas using the same surgical technique. The twelve patients will be recruited from the local waiting list for patients to be undergoing corneal grafting. If the patients meet the inclusion criteria and agree to participate following oral and written consent, they will be randomized to either group. The patients will be followed for 12 months and documented with OCT, In Vivo Confocal Microscopy, slit lamp photography a o. The study is planned as a safety study with initial efficacy documentation.