Open-label Prospective Clinical Trial Evaluating the Safety and Efficacy of Biosynthetic CLP-PEG-MPC Corneal Implants in Patients Undergoing High-risk Deep Anterior Lamellar Keratoplasty.

This is an open-label and prospective clinical trial, in which a maximum of 5 eyes of 5 patients will receive a CLP-PEG-MPC synthetic cornea during deep anterior lamellar keratoplasty (DALK) surgery and will be followed up over 24 months.

Inclusion Criteria:adult age (18 years or older at the time of subject eligibility visit)able to provide signed, informed consentunilateral corneal opacity not involving the posterior corneal layers (Descemet membrane and endothelium) for which DALK is indicatedvisual acuity less than 20/200 in the affected eye and better than 20/50 in the contralateral eye (i.e. monocular blindness)presence of at least one of the following high-risk criteria for corneal transplantation using a human cornea donor graft: 5i) inflammation 5ii) active infection 5iii) stromal neovascularization 5iv) neurotrophism 5v) autoimmune disease 5vi) previous DALK graft failureavailability for 24 months of postoperative follow-upExclusion Criteria:Age under 18 yearsInability to give informed consentPrevious corneal perforation precluding DALK surgeryEndothelial pathology requiring penetrating keratoplastyLimbal stem cell deficiency affection more than 50% of the limbusPrevious penetrating or endothelial keratoplastyBilateral blindnessNystagmusUncontrolled glaucoma or intraocular pressureDocumented macular disease (age-relate macular degeneration, macula-involving retinal detachment, macular hole)Documented amblyopia of surgical eye