Clinical Trials in Spain / NCT06451718
Recruiting
Not applicable
First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus
NCT06451718 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Keratoconus
Investigational drug(s) / intervention(s)
Nitinol net for intracorneal implant for keratoconus treatment
Nitinol net for intracorneal implant for keratoconus treatment: The investigational corneal implant device is designed for patients with keratoconus. It is intended to be surgically implanted into the cornea as a permanent implant and is made of nitinol. The device is intended to improve corneal stability and visual outcomes.
Study 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
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).
Primary outcome measure(s)
- Incidence of Serious Adverse Device Effects (SADE), Adverse Events (AE), and Serious Adverse Events (SAE) — From enrolment up to 12 months post-procedure
Number and type of adverse events, serious adverse events, and serious adverse device effects observed during follow-up. - Changes in corneal alterations from baseline to 12 months. — From baseline up to 12 months post-procedure
Slit Lamp corneal assessments to evaluate: * Corneal inflammation * Corneal infection * Corneal stromal lysis * Corneal melting * Corneal stromal infiltration * Corneal neo vessels * Persistent corneal epithelial defects Observations will be graded from 0 (Absence) to 3 (Severe) - Changes in total and epithelial corneal thickness (central and minimum) from baseline to 12 months. — From baseline up to 12 months post-procedure
Measurement of total and epithelial corneal thickness (central and minimum) - Changes in IOP from baseline to 12 months — From baseline up to 12 months post-procedure
IOP is measured with tonometer - Changes in corrected IOP (bIOP) from baseline to 12 months — From baseline up to 12 months post-procedure
bIOP is measured using a biomechanically based tonometry method - Changes in macular central thickness from baseline to 12 months — From baseline up to 12 months post-procedure
Central macular thickness is assessed with a posterior Optical Coherence Tomography (OCT). - Changes in Endothelial Cell Count (ECC) from baseline to 12 months — from baseline up to 12 months post-procedure
Corneal endothelium assessment is performed with specular microscope - Subjective numeric scale related to several ocular symptoms — From baseline to 12 months post-procedure
Subjective numeric scale ranked from 0 (no pain at all) to 10 (the maximum pain ever felt) related to pain, foreign body sensation, tearing, photophobia, glare and halos
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | Roma | Not Yet Recruiting |
| Instituto de Microcirugía Ocular de Barcelona (IMO) | Barcelona | Bar | Recruiting |
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Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06451718 on ClinicalTrials.gov ↗ ← All trials in Spain