Trial interventions

In both allocation groups, the surgical procedure is performed using topical or local (peribulbar or subtenoniane) anaesthesia. All patients allocated to the experimental arm are implanted with a bioengineered human allogeneic anterior lamellar cornea, obtained as described previously. The tissue-engineered implant covers the corneal scarring or defect as a graft, after debridement and preparation of the injury bed performing a 50–100 µm-thick keratectomy. The bioengineered corneal graft is implanted in the corneal lesion with the epithelial surface facing up, using interrupted 10–0 nylon sutures. Corneal sutures are removed 3–5 weeks after the implantation. Patients allocated to the control arm receive AM transplantation using a mixed graft/patch technique, named the sandwich technique, which is applied to cover the area of the corneal lesion after debridement and preparation of the injury bed.³⁰

During the post-implantation follow-up, patients receive routine medical care based on existing clinical protocols for AM and corneal transplants procedures, as indicated in table 2.

Concomitant medication