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Cornea transplant showdown: which surgery gives sharper sight?

NCT ID NCT05436665

Disease control Sponsor: University Hospital, Antwerp Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 2 times

Summary

This study compares two types of cornea transplant surgery—DSAEK and DMEK—in 220 adults with corneal swelling or Fuchs' dystrophy. The goal is to see which procedure leads to better vision and patient satisfaction one year after surgery. Participants will be randomly assigned to one of the two surgeries and followed for 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
Cornea transplant surgery (DSAEK or DMEK procedure)
What this could lead to
If successful, this study could show which cornea transplant method gives better vision and patient satisfaction, helping doctors choose the best option for each patient.
What could go wrong
This is a comparative effectiveness trial, not a test of a new drug or cure. Results may not apply to all patients, and both procedures carry standard surgical risks like infection or 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.

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 220 people

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

Started

Aug 2022

Expected to finish

Jun 2028

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: * Fuchs Endothelial Dystrophy (FED); * Bullous Keratopathy (BK); * Other miscellaneous causes of endothelial dysfunction including decompensation of a previous corneal graft; * Pseudophakic (post cataract surgery); * Patients over 18 with the capacity to read and to understand the study information and to give informed consent, as well as study quality of life questionnaires; * Patients willing and capable to attend the 3, 6, and 12-month follow-up appointments. Exclusion Criteria: * Inability to provide informed consent; * Patients unable to attend the proposed follow up; * Inclusion of the fellow eye in the study; * Complex surgery combined with multiple pathologies (i.e., glaucoma surgery); * Other contraindications to lamellar corneas surgery; * Patients who elect not to participate; * Patients under 18 years of age; * Patients that are currently pregnant or breastfeeding; * Phakic patients with no direct plan to perform cataract surgery.

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Conditions

The condition(s) this trial relates to.

bullous keratopathy corneal edema corneal endothelial dystrophy Fuchs' endothelial dystrophy

As listed by the trial registrant

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

Bullous keratopathy Corneal edema Corneal endothelial disorder Fuchs' endothelial dystrophy Pseudophakic bullous keratopathy

Contacts and locations

Locations

  • AZ Imelda

    Bonheiden, Belgium

  • AZ Maria Middelares

    Ghent, Oost-Vlaanderen, Belgium

  • AZ Monica (campus Deurne)

    Deurne, Belgium

  • AZ Sint-Jan Brugge

    Bruges, West-Vlaanderen, Belgium

  • Antwerp University Hospital

    Edegem, Antwerp, 2650, Belgium

  • CHU Liège

    Liège, Belgium

  • Erasmus ziekenhuis Brussel

    Brussels, Belgium

  • UZ Brussel

    Brussels, Belgium

  • UZ Gent

    Ghent, Belgium

  • UZ Leuven

    Leuven, Belgium

  • Ziekenhuis Oost-Limburg (ZOL)

    Genk, Belgium

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