3D-Printed eye patch could save sight without a donor

NCT ID NCT07440186

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3D-printed human collagen implant in 4 people with severe corneal melting, a condition where the eye's clear front layer thins and can perforate. The implant is placed on the eye to reinforce the cornea and prevent vision loss. The main goal is to check if the implant is safe and biocompatible.

What this could mean

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

Active substance
3D-printed human collagen implant
What this could lead to
If it works, this could offer a safer, rejection-free way to repair severe corneal damage and prevent blindness without needing a human donor.
What could go wrong
This is a very early, tiny trial with only 4 participants, so results may not apply broadly. The implant could fail to integrate, cause infection, or not improve 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 4 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

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.

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: 1. Age over 18 years. 2. Patients who, after receiving detailed information about the design, purpose, risks, and implications of the study, and about their right to withdraw at any time without repercussions, give their informed written consent. 3. Confirmed diagnosis of severe corneal melting. 4. Absence of response to conventional non-surgical treatments, which must include: * Intensive antibiotic, antifungal, or antiviral treatment according to etiology. * Anti-inflammatory or immunomodulatory eye drops (such as corticosteroids, cyclosporine, tacrolimus). * Intensive lubrication and/or autologous serum. * Use of therapeutic contact lenses. * The patient must not have responded satisfactorily to these measures and must show progression or persistence of the ulcer, thinning, and structural risk. The absence of response is not defined by a specific number of treatments, but by the lack of clinical improvement or progression of the condition despite having received several of these measures appropriately. In particular, progression of the epithelial defect, worsening stromal thinning, or the appearance of signs of perforation risk will be considered an absence of response, which would justify surgical intervention. 5. If the patient has previously undergone surgical procedures or received other implants (such as amniotic membrane, conjunctival flap, or Tenon's graft), this will be included if there is documented clinical progression without sufficient functional or structural recovery, and provided that there are no surgical alternatives with documented superior efficacy in their specific situation. Exclusion Criteria: 1. Pregnancy or breastfeeding. 2. Refusal to participate in the study. 3. Presence of active eye infection. 4. Systemic diseases that may affect healing. 5. Known hypersensitivity to collagen compounds. 6. Any circumstance that, in the investigator's opinion, makes the patient's participation in the clinical research inadvisable.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Patients with severe corneal melting are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. 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 ↗

  2. 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.