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Eye transplant breakthrough? new check could save sight

NCT ID NCT05847387

Knowledge-focused Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study involves 135 adults getting a cornea transplant. Surgeons will use a new method to check the health of donor eye tissue before surgery. The goal is to see if this check helps predict how well the transplant will work long-term, reducing the chance of graft failure.

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.

Participants

About 135 people

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

Started

Dec 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Consecutive patients undergoing keratoplasty at participating referral cornea clinics

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: * Age older than 18 years old * Planned corneal transplantation: perforating keratoplasty (PK), Descemet stripping automated endothelial keratoplasty (DSAEK), ultra-thin DSAEK (UT-DSAEK) or Descemet membrane endothelial keratoplasty (DMEK) * Indication for corneal transplantation (low-moderate risk of rejection): keratoconus, Fuchs endothelial dystrophy * Ability to provide written informed consent. Exclusion Criteria: * Prior corneal transplantation * Planned preloaded DSAEK or preloaded DMEK * Planned keratoplasty not involving corneal endothelium transplantation (i.e., superficial/deep anterior lamellar keratoplasty) * Evidence of concurrent microbial keratitis * Evidence of non-infectious or autoimmune keratitis * Impending or frank corneal perforation * Uncontrolled, elevated intraocular pressure (IOP)- Previous glaucoma surgery * Acute or chronic inflammatory/infectious anterior segment uveitis * Presence of an anterior chamber intraocular lens (IOL) for phakic or aphakic purposes

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Conditions

The condition(s) this trial relates to.

Corneal Endothelial Cell Loss Fuchs' endothelial dystrophy keratoconus transplant rejection

As listed by the trial registrant

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

Corneal endothelial cell loss Corneal transplant failure

How to take part

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

  1. The places running it

    12 sites in 6 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

  • Antwerp University Hospital

    NOT_YET_RECRUITING

    Edegem, 2650, Belgium

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    RECRUITING

    Brescia, BS, 25123, Italy

  • Department of Experimental Medicine, Tor Vergata School of Medicine and Surgery

    NOT_YET_RECRUITING

    Roma, 00133, Italy

  • Department of Medical and Surgical Sciences, University Magna Græcia

    NOT_YET_RECRUITING

    Catanzaro, 88100, Italy

  • Department of Ophthalmology, University of Cologne

    NOT_YET_RECRUITING

    Cologne, 50937, Germany

  • Fondazione Banca degli Occhi del Veneto

    NOT_YET_RECRUITING

    Venice, 30174, Italy

  • Hospital Regional Universitario de Málaga

    NOT_YET_RECRUITING

    Málaga, 29010, Spain

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

  • Maastricht University Medical Center

    NOT_YET_RECRUITING

    Maastricht, 6229, Netherlands

  • Münster University Hospital

    NOT_YET_RECRUITING

    Münster, 48149, Germany

  • Royal Liverpool University Hospital

    NOT_YET_RECRUITING

    Liverpool, L7 8YE, United Kingdom

  • San Bortolo Hospital

    NOT_YET_RECRUITING

    Vicenza, 36100, Italy

More trials for these conditions

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