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Study identifier: NCT06451718 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Keratoconus  ·  Sponsor: Recornea Srl

PhaseNA
Planned participants12
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Emiliano Lepore, Ing., PhD  ·  +39 3209673891  ·  el@recornea.com

Rossella Baldini, PhD  ·  rb@recornea.com

Always discuss trial participation with your own doctor first.

Locations (2)

Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, Roma, ItalyNot Yet Recruiting
Instituto de Microcirugía Ocular de Barcelona (IMO)Barcelona, Bar, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT06451718