Status: Recruiting
First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus
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.
Participants needed: 12
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Recornea SrlUpdated: Jan 20, 2026Locations: 2
Eligibility criteria
Signed and dated informed consent form. [+10]
Inability of patient and/or relatives to understand the clinical investigation p... [+5]