Evaluation of Safety and Efficacy of a Bioengineered Corneal Implant for Treatment of Keratoconus

Inclusion Criteria: * Advanced keratoconus (according to Amsler-Krumeich classification) * No corneal scar * Male or female aged ≥ 18 years, no upper age limit * Subjects indicated for a first corneal stromal transplantation (treatment naïve) * Corneal thickness (including epithelium) at least 300µm centrally, as measured by OCT. * Patients who gave their written signed and dated informed consent for participation Exclusion Criteria: * Prior corneal surgery (e.g., refractive surgery, cataract, collagen cross-linking, endothelial keratoplasty, etc.) * Dry eye / tear film pathology * Active ocular infection * Glaucoma / ocular hypertension * Active corneal ulceration * Acute or chronic disease or illness that would increase the operation risk or confound the outcomes of the study (immune- compromised, connective tissue disease, clinically significant atopic disease, etc.) * Any other medical condition that in the judgment of the clinical investigator or corneal surgeon is not compatible with the study procedures * General history judged by the investigator to be incompatible with the study (e.g., life-threatening patient condition, other condition where postoperative follow-up may be difficult). * known diabetes or other neuro-degenerative disorder (as corneal nerves can be affected leading to impaired wound healing) * Inability of patient to understand the study procedures and thus inability to give informed consent. * Participation in another clinical study within the last…