First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus

Inclusion Criteria: * Signed and dated informed consent form. * Male and female ≥ 18 years old. * Not recommended for ICRS. * Recommended for keratoplasty. * Minimum corneal thickness ≥ 350 μm. * Best Distance Spectacle Corrected Visual Acuity (BDSCVA) with the ETDRS test ≥ 0.30 logMAR (\<= 0,50 decimal notation). * BCVA with RGP contact lens with the ETDRS test 10 letters or more than BCVA with spectacles. * Have stable or stabilized disease for 12 months (in case of crosslinking, it must have been done at least 12 months prior to intervention). * Have a KC stage 3-4 according to Investigator's judgement, with a central K readings \> 47.2 D and RMS of coma aberration \> 2.5 μm. * Have no known or suspected allergy to nickel. * Female subject of childbearing potential is eligible to participate if declaring she is not pregnant, or not breastfeeding and agree to use highly effective contraception (defined as method which results in a failure rate of \<1% annually) and must abstain from egg donation or storage throughout the study period. Exclusion Criteria: * Inability of patient and/or relatives to understand the clinical investigation procedures and thus inability to give informed consent. * Untreated progressive KC. * Single functioning eye. * Other ocular diseases (eyelids malposition, uveitis, ocular hypertension, glaucoma, cataract, retinal disorders) or corneal surgeries (refractive corneal surgery, keratoplasty), except corneal crosslinking. * Systemic collagenopathies and/or vasculitis, and other diseases that in the opinion of the principal Investigator, may be contraindicated. * Suspected or known intolerance or hypersensitivity to any of the treatments indicated in the CIP and/or to any component of the device (i.e. nickel).