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

NCT06451718 | Recruiting

• 1 other identifier: REMKERA
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 2

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.

Conditions

Keratoconus

Keywords

GROSSO; Implant; Cornea; Surgery; Reshaper; keratoconus; keratoplasty; nitinol; corneal shape; remodeling

Outcome Measures

Primary Outcomes (8)

• Incidence of Serious Adverse Device Effects (SADE), Adverse Events (AE), and Serious Adverse Events (SAE)

  Number and type of adverse events, serious adverse events, and serious adverse device effects observed during follow-up.

  From enrolment up to 12 months post-procedure

• Changes in corneal alterations from baseline to 12 months.

  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)

  From baseline up to 12 months post-procedure

• Changes in total and epithelial corneal thickness (central and minimum) from baseline to 12 months.

  Measurement of total and epithelial corneal thickness (central and minimum)

  From baseline up to 12 months post-procedure

• Changes in IOP from baseline to 12 months

  IOP is measured with tonometer

  From baseline up to 12 months post-procedure

• Changes in corrected IOP (bIOP) from baseline to 12 months

  bIOP is measured using a biomechanically based tonometry method

  From baseline up to 12 months post-procedure

• Changes in macular central thickness from baseline to 12 months

  Central macular thickness is assessed with a posterior Optical Coherence Tomography (OCT).

  From baseline up to 12 months post-procedure

• Changes in Endothelial Cell Count (ECC) from baseline to 12 months

  Corneal endothelium assessment is performed with specular microscope

  from baseline up to 12 months post-procedure

• Subjective numeric scale related to several ocular symptoms

  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

  From baseline to 12 months post-procedure

Secondary Outcomes (19)

• Changes in Best Distance Spectacle Corrected Visual Acuity (BDSCVA) from baseline to 12 months

  From baseline up to 12 months post-procedure

• Changes in topographic keratometry values from baseline to 12 months

  From baseline up to 12 months post-procedure

• Changes in topographic and refractive astigmatism from baseline to 12 months

  From baseline up to 12 months post-procedure

• Changes in Manifest Refraction Spherical Equivalent (MRSE) from baseline to 12 months

  From baseline up to 12 months post-procedure

• Changes in Symmetry Index (SI) from baseline to 12 months

  From baseline up to 12 months post-procedure

Study Arms (1)

Study group

EXPERIMENTAL

All participants will undergo the planned surgical intervention for the implantation of the investigational medical device and will be monitored for up to 1 year after the procedure.

Device: Nitinol net for intracorneal implant for keratoconus treatment

Interventions

Nitinol net for intracorneal implant for keratoconus treatment DEVICE

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 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Recornea Srl: lead

Study Sites (2)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Roma, 00168, Italy

NOT YET RECRUITING

Instituto de Microcirugía Ocular de Barcelona (IMO)

Barcelona, Bar, 08035, Spain

RECRUITING

Related Links

• Sponsor official website

MeSH Terms

Conditions

Keratoconus; Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Edoardo Grosso, MD

  Chief Medical Officer (CMO)

  STUDY DIRECTOR

• José L. Güell, MD

  Head of the Cornea, Cataract and Refractive Surgery Department at IMO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emiliano Lepore, Ing., PhD

CONTACT

+39 3209673891; el@recornea.com

Rossella Baldini, PhD

CONTACT

rb@recornea.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled subjects with keratoconus will receive the surgical intervention and will be followed for up to 1 year post-procedure

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: June 11, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

IT (1); ES (1)