NCT06451718 First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus
| NCT ID | NCT06451718 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Recornea Srl |
| Condition | Keratoconus |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-09-03 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2024-09-03 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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).
Contact & Investigator
Edoardo Grosso, MD
STUDY DIRECTOR
Chief Medical Officer (CMO)
Frequently Asked Questions
Who can join the NCT06451718 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Keratoconus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06451718 currently recruiting?
Yes, NCT06451718 is actively recruiting participants. Contact the research team at el@recornea.com for enrollment information.
Where is the NCT06451718 trial being conducted?
This trial is being conducted at Roma, Italy, Barcelona, Spain.
Who is sponsoring the NCT06451718 clinical trial?
NCT06451718 is sponsored by Recornea Srl. The principal investigator is Edoardo Grosso, MD at Chief Medical Officer (CMO). The trial plans to enroll 12 participants.