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Tests a small implanted nitinol device for advanced keratoconus of the eye

Tests the GROSSO implant, placed in the cornea, in adults with advanced keratoconus.

Key facts

Who runs it
Recornea Srl
Where
Italy and Spain2 sites in 2 countriesChoose a country to see its sites
Trial code
Registry title
First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus
Status
Recruiting
People taking part
12 people, planned
Started
3 Sept 2024
Expected to end
Feb 2027
Type of study
Interventional
Treatments tested
  • Nitinol net for intracorneal implant for keratoconus treatment
Record updated
20 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced keratoconus (stage 3 or 4) who would otherwise be candidates for a cornea transplant. They will receive a new nitinol net implant placed inside the cornea.

Age
18 years and older
Sex
Men and women
Disease stage
Keratoconus stage 3-4, stable for 12 months. Central K readings > 47.2 D and RMS of coma aberration > 2.5 μm. Minimum corneal thickness ≥ 350 μm. Spectacle-corrected vision (BDSCVA) ≥ 0.30 logMAR (<= 0,50 decimal). Vision with RGP contact lens 10 letters or more better than with spectacles. Not a candidate for ICRS (corneal ring implants), but a candidate for keratoplasty (cornea transplant).
Earlier treatment
If corneal crosslinking was done, it must have been at least 12 months before the procedure. People who had other corneal surgery (refractive surgery, keratoplasty) cannot join.

Main reasons for not taking part

  • Keratoconus that is getting worse and has not been treated
  • Only one working eye
  • Other eye diseases such as glaucoma, cataract, uveitis, ocular hypertension, retinal or eyelid problems
  • Known or suspected allergy to nickel or any part of the device
  • Systemic collagen diseases or vasculitis; pregnancy or breastfeeding

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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

This trial has no sites in United States.

It has sites in 2 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The group in the trial

  • Study groupTreatment being tested

    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.

    Treatment: Nitinol net for intracorneal implant for keratoconus treatment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
First in Human Study to Assess the Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Stage 3 and 4 Keratoconus
Plain-language title
Tests a small implanted nitinol device for advanced keratoconus of the eyeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
20 January 2026