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Porcine collagen implant could help avoid corneal transplants

NCT ID NCT04741230

Disease control Sponsor: The Royal Wolverhampton Hospitals NHS Trust 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new device called the Gebauer Lenticule, a tiny implant made from pig collagen, for people with severe keratoconus or post-LASIK ectasia. The implant is placed inside the cornea to strengthen it and improve stability, potentially delaying or avoiding the need for a corneal transplant. The trial will enroll 15 adults and focus on safety, tolerability, and early signs of effectiveness.

What this could mean

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

Active substance
Gebauer Lenticule (porcine collagen corneal implant)
What this could lead to
If successful, this implant could offer a less invasive, reversible option to strengthen the cornea and delay or avoid the need for a corneal transplant.
What could go wrong
This is a very early feasibility study with only 15 participants, so results may not apply to everyone. Risks include implant rejection, inflammation, or no improvement in vision.

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 15 people

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

Started

May 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 79 years

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: * Diagnosis of severe keratoconus in patients who would prefer to avoid corneal transplant surgery / penetrating keratoplasty OR * Diagnosis of severe post-LASIK Ectasia in patients who would prefer to avoid corneal transplant surgery / penetrating keratoplasty * In terms of general health, patients must be free of diagnosed terminal illnesses (life expectancy of greater than or equal to 2 years). * Patients must be aged 18 years or over and less than 80 years old * Patients' contact lenses must have been removed at least one-week prior to surgery for soft lenses and two weeks prior to surgery for hard lenses * Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed * Patient must be able and willing to complete all study visits and comply with the study-specific requirements Exclusion Criteria: * History or presence of any ocular pathologies that may interfere with the planned surgical treatment, including corneal epithelial problems * Previous corneal transplantation or corneal implant in the designated eye * Cataract with anticipated surgical intervention (IOL implantation) within 2 years * Active inflammation and/or infection of the eye or the eye lid * Patients with Intra Ocular Pressure (IOP) \<10 mmHg or \>21 mmHg * Professionally diagnosed and currently treated autoimmune diseases * Current strong symptoms of any allergy * History of major organ transplantation and/or current continuing immunosuppressive treatment * History of blood transfusion within the last 12 months * Subject who is currently participating or has participated in another investigational clinical study within the past 60 days Pregnancy and lactation

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Conditions

The condition(s) this trial relates to.

corneal ectasia keratoconus

As listed by the trial registrant

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

Keratoconus Post-laser retinal condition

How to take part

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

  1. The places running it

    1 site. 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

  • The Royal Wolverhampton NHS Trust

    RECRUITING

    Wolverhampton, West Midlands, WV10 0QP, United Kingdom

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