Implantable device for treating advanced keratoconus
First in Human Study to Assess the Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Stage 3 and 4 Keratoconus
This study is testing a new implant for people with advanced keratoconus to see if it can improve their vision when other treatments aren't an option.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Recornea Srl Industry-sponsored |
| Locations | 2 sites (Roma, Roma and 1 other locations) |
| Trial ID | NCT06451718 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a novel intra-corneal nitinol device, known as the GROSSO® implant, designed for patients with advanced keratoconus. The device is a permanent implant that modifies corneal shape to improve vision by being surgically inserted into the cornea. The study focuses on adults with stage 3-4 keratoconus who are not suitable for other treatments and are recommended for keratoplasty. Participants will be monitored for the device's performance and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage 3-4 keratoconus who are not suitable for Intrastromal Corneal Ring Segments and are recommended for keratoplasty.
Not a fit: Patients with untreated progressive keratoconus, single functioning eyes, or other significant ocular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with advanced keratoconus, potentially preserving their vision and delaying the need for corneal transplantation.
How similar studies have performed: While this approach is novel, similar studies involving corneal implants have shown promise in improving vision outcomes for keratoconus patients.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Roma, Roma and 1 other locations
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Roma, Italy (Not_yet_recruiting)
- Instituto de Microcirugía Ocular de Barcelona (IMO) — Barcelona, Bar, Spain (Recruiting)
Study contacts
- Principal investigator: José L. Güell, MD — Head of the Cornea, Cataract and Refractive Surgery Department at IMO
- Study coordinator: Emiliano Lepore, Ing., PhD
- Email: el@recornea.com
- Phone: +39 3209673891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.