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Metal mesh implanted in eye could halt keratoconus

NCT ID NCT06451718

Disease control Sponsor: Recornea Srl Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests a tiny, permanent metal mesh (nitinol) implant placed inside the cornea to stabilize the eye and improve vision in people with advanced keratoconus. The trial involves 12 adults who are not candidates for other treatments and are currently recommended for a corneal transplant. Researchers will closely monitor safety and any changes in vision and corneal shape over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nitinol net implant (GROSSO® implant)
What this could lead to
If successful, this could offer a new surgical option to stabilize the cornea and improve vision in people with advanced keratoconus, potentially delaying or avoiding a corneal transplant.
What could go wrong
This is a very early, first-in-human trial with only 12 participants, so safety and effectiveness are not yet proven. The implant is permanent, and risks include inflammation, infection, or device-related complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

corneal disorder keratoconus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Keratoconus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    NOT_YET_RECRUITING

    Roma, Roma, 00168, Italy

  • Instituto de Microcirugía Ocular de Barcelona (IMO)

    RECRUITING

    Barcelona, Bar, 08035, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.