This Study is a First In Human clinical investigation addressed to evaluate the safety and efficacy of a novel intra-corneal nitinol device (Investigational Medical Device: GROSSO® implant) for the treatment of advanced keratoconus disease of the eye.
Signed and dated informed consent form.
Male and female ≥ 18 years old.
Not recommended for ICRS.
Recommended for keratoplasty.
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.
Recornea Srl
Lead sponsor