This is a prospective, phase I-II, randomised, open-label clinical trial that will evaluate the safety and feasibility, as well as clinical efficacy evidence, of a bioengineered anterior corneal substitute in adults with severe trophic corneal ulcers. This model of human anterior allogeneic cornea will provide an alternative approach in cases where human donor keratoplasty is not an option.
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Adverse events (and serious adverse events) causally related to experimental treatment.
Timeframe: 24 months
Implant status (integrity, detachment and reabsorption)
Timeframe: 24 months
Local, regional or systemic infections related with the implant
Timeframe: 24 months
Induced corneal neovascularization
Timeframe: 24 months