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 byOCT.

• 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 orconfound 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 orcorneal 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-upmay be difficult).

• known diabetes or other neuro-degenerative disorder (as corneal nerves can beaffected leading to impaired wound healing)

• Inability of patient to understand the study procedures and thus inability to giveinformed consent.

• Participation in another clinical study within the last 3 months

• Already included once in this study (can only be included for one treated eye).