An interventional study of UT-DSAEK and DMEK in Corneal Edema, Corneal Endothelial Disorder and Fuchs' Endothelial Dystrophy, sponsored by University Hospital, Antwerp. Active, not recruiting at 11 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Treatment
This study is designed as a randomised multicentric parallel group pragmatic trial of Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) in corneal endothelial decompensation. the purpose is to compare the clinical and patient reported outcomes of both therapies across a broad range of indications.
The current problem concerns variability in the provision of corneal endothelial keratoplasties available to patients in Belgium. Some patients receive DSAEK and some (albeit fewer) receive DMEK. Currently the type of corneal graft that a patient receives depends on the treating surgeon opinions.
In this study 220 patients in 11 surgical centres will be recruited and allocated to one of the two surgical options. Both the Ultrathin DSAEK and DMEK grafts will be prepared by corneal banks in the University Hospital of Liege and University Hospital of Antwerp respectively. Patients will be examined preoperatively and postoperatively at 3, 6 and 12 months. Clinical information such as best-corrected visual acuity and refraction will be collected as well as quality of life information based on the EQ-5D-5L and the VFQ 25 assessment tools. These data be used to compare the interventions both on the clinical level as well as from the patient perspective.
39 studies on the registry are indexed under Corneal Edema; 8 are open to participants now.
This study's planned enrollment of 220 is above the median of 52 across 31 interventional studies indexed under Corneal Edema.
Browse Corneal Edema studies →University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) refers to the use of a corneal endothelial/Descemet graft with a thin layer of stroma (\<110um) attached. The cornea is made up of 5 layers, all of which work to provide a clear image on the retina. The innermost layer of cells, the endothelium, is responsible for pumping fluid out of the cornea and keeping it transparent: a normal endothelium is essential to keeping the cornea clear. The endothelium lies on a membrane called the Descemet membrane. The thickest layer of the cornea is called the stroma and this provides rigidity and strength to the cornea. When the corneal endothelium fails, it cannot regrow and the best treatment is to replace the cells with healthy donor cells. This is called a corneal endothelial transplantation or endothelial keratoplasty. In the DSAEK technique, a piece of the donor's endothelium is transplanted with a supporting layer of donor stroma.
Procedure: UT-DSAEK
Descemet membrane endothelial keratoplasty refers to the use of a corneal endothelial/Descemet graft with no layer of associated stroma (15-20um thick). The cornea is made up of 5 layers, all of which work to provide a clear image on the retina. The innermost layer of cells, the endothelium, is responsible for pumping fluid out of the cornea and keeping it transparent: a normal endothelium is essential to keeping the cornea clear. The endothelium lies on a membrane called the Descemet membrane. The thickest layer of the cornea is called the stroma and this provides rigidity and strength to the cornea. When the corneal endothelium fails, it cannot regrow and the best treatment is to replace the cells with healthy donor cells. This is called a corneal endothelial transplantation or endothelial keratoplasty. In the DMEK technique only a piece of donor endothelium layer is together with its supporting membrane (the Descemet membrane), is transplanted.
Procedure: DMEK
The main incision (3.5-5mm) is created at the corneal limbus or via a cornea-scleral tunnel with 2-3 smaller (approx. 1mm) paracentesis incisions. An ophthalmic viscosurgical device (OVD) or a continuous infusion of water or air can be used to maintain the stability of the anterior chamber, according to the surgeon's preference. The corneal endothelium is scored using a scoring instrument and the central diseased corneal endothelium is removed. Once the anterior chamber is prepared, OVD or air has been removed, then the eye is ready for the new corneal graft. The pre-cut corneal tissue delivered by the bank is then gently rinsed and may be stained with 0.06% trypan blue if required. The tissue is loaded into a glide or injector, and pulled into the anterior chamber using a smooth-tipped micro-forceps (e.g., Busin forceps). Once the graft enters the eye, it is lifted to the posterior cornea. The graft is further centred using air (or SF6 Gas) in the anterior chamber.
Also known as: Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty
The main incision (2.8-3mm) is created superior or temporally at the corneal limbus and is accompanied by 2-3 smaller paracentesis incisions. An ophthalmic viscosurgical device (OVD) or a continuous infusion of water or air can be used to maintain the stability of the anterior chamber. The corneal endothelium is scored using a scoring instrument and the central diseased corneal endothelium is removed. The DMEK roll is poured into a basin and rinsed. The graft is then stained with 0.06% trypan blue to aid in graft visualization. The graft is loaded into an injector and introduced into the anterior chamber. The graft is unrolled using external manoeuvres and once unrolled, it is lifted to the back of the cornea. The eye is then pressurised with a full air fill from 10 to 120 minutes. The pressure is then reduced and the case is completed by suturing any incisions required.
Also known as: Descemet Membrane Endothelial Keratoplasty
BCVA 12m
Best-corrected visual acuity expressed in LogMAR
Time frame: 12 months
BCVA 3 and 6m
Best-corrected visual acuity expressed in LogMAR
Time frame: 3 and 6 months
UCVA 3,6 and12m
Uncorrected visual acuity expressed in LogMAR
Time frame: 3, 6 and 12 months
Change in refraction
Change in objective refraction - spectacle correction
Time frame: 3, 6 and 12 months
Proportion of high vision
Proportion of patients to achieve 0.2 LogMAR visual acuity or less
Time frame: 12 months
EQ-5D-5L
Quality of life measured by the fifth level EuroQol (EQ-5L) instrument where five dimensions are scored at 5 levels - the higher the level, the worse the health state. The digits for the five dimensions can be combined to a 5-digit number to describe the patient's health state
Time frame: 3, 6 and 12 months
VFQ 25
Vision related quality of life measured by the Visual Function Questionnaire(VFQ-25) scored on a scale of 0-100, with a higher score reporesenting higher quality of vision related quality of life.
Time frame: 3, 6 and 12 months
ECC
Endothelial cell count
Time frame: 3, 6 and 12 months
CCT
Central corneal thickness
Time frame: 3, 6 and 12 months
Complications
Complications associated with the intervention
Time frame: 12 months
Plan to share: Yes — Data sharing of the final trial dataset will be offered in the following manner: The Chief Investigator, Trial Steering Committee, and the Sponsor (including data monitors) will have access to the trial dataset, but a site's Prinicpal Investigator may submit a request for data access. This will be discussed and approved by the Trial Steering Committee. Upon conclusion of the trial, individual participant data that underlie the results reported in the article (after deidentification) will be shared upon the request of any relevant interested party. Access to the final trial dataset by other parties: reasonable requests for access to trial data from other parties will be considered and approved in writing where appropriate, following formal application to the Trial Steering Committee (bestcornea@uza.be).
Supporting information: Study protocol
Time frame: The article with regards to the study protocol is now under revision in an open acces medical journal.
Access criteria: The article with regards to the study protocol will be published in an open access medical journal.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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