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Can a delicate cornea transplant work after other eye surgeries?

NCT ID NCT06013462

Disease control Sponsor: Fondation Ophtalmologique Adolphe de Rothschild 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at how safe and effective DMEK (a type of cornea transplant) is for people who have already had eye surgeries like vitrectomy or glaucoma surgery. Researchers will track serious complications and vision improvement over 12 months in 80 participants. The goal is to see if DMEK can be a good option even in these more challenging cases.

What this could mean

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

Active substance
Descemet Membrane Endothelial Keratoplasty (DMEK) surgery
What this could lead to
If successful, this study could show that DMEK surgery is safe and effective even for patients with complicated eye histories, potentially improving vision outcomes for this group.
What could go wrong
This is an observational study with only 80 participants, so results may not apply to everyone. The surgery itself carries risks like graft detachment or rejection, especially in these complex cases.

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 80 people

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

Started

Mar 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Who is studied

Group of 80 patients admitted for consultation at the Hôpital Fondation Adolphe de Rothschild up to one year prior to endothelial transplantation and meeting the above eligibility criteria.

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 : * Patients scheduled for corneal endothelial transplantation in one or both eyes * History of vitrectomy, trabeculectomy, large iris defects, anterior synechiae on the eye to be operated on * Pseudophakia or aphakia in the eye to be operated on * Express consent to participate in the study * Affiliated or beneficiary of a social security scheme Exclusion Criteria : * Need for combined PKE + EK surgery * Primary endothelial decompensation * At least one contraindication to endothelial transplantation : * Presence of a stromal corneal cleft * Inflammatory or degenerative corneal pathology other than endothelial * Progressive corneal infection * Degenerative retinal pathology not allowing visual recovery postoperatively (for the purposes of this study, we accept patients who have had retinal detachment and whose loss of vision is clearly attributable to endothelial decompensation) * End-stage glaucoma not allowing visual recovery post-operatively (for this study, we accept patients who have had filtering surgery for glaucoma, which is stabilized at the time of surgery. Decline in vision must be clearly attributable to endothelial decompensation) * Medical contraindication to general or local anesthesia * Patient under legal protection * Pregnant or breast-feeding women

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Conditions

The condition(s) this trial relates to.

corneal edema

As listed by the trial registrant

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

Patients undergoing dmek with A history of anterior or posterior segment surgery

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

  • Fondation Ophtalmologique A de Rothschild

    RECRUITING

    Paris, 75019, France

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