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Corneal EdemaBESTCorneaNCT05436665

The Belgian Endothelial Surgical Transplant of the Cornea

A study testing UT-DSAEK and DMEK in people with Corneal Edema and Corneal Endothelial Disorder, run by University Hospital, Antwerp at 11 sites in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
UT-DSAEK and DMEK
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
11 sitesBelgium
Study dates
10 Aug 2022to 6 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • Inability to provide informed consent;
  • Patients unable to attend the proposed follow up;

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Belgium11 sites

  • AZ Imelda

    Bonheiden

  • AZ Sint-Jan Brugge

    Bruges, West-Vlaanderen

  • Erasmus ziekenhuis Brussel

    Brussels

  • UZ Brussel

    Brussels

  • AZ Monica (campus Deurne)

    Deurne

  • Antwerp University Hospital

    Edegem, Antwerp, 2650

  • Ziekenhuis Oost-Limburg (ZOL)

    Genk

  • AZ Maria Middelares

    Ghent, Oost-Vlaanderen

  • UZ Gent

    Ghent

  • UZ Leuven

    Leuven

  • CHU Liège

    Liège

Other trials in Belgium

About this study

Official title: The Belgian Endothelial Surgical Transplant of the Cornea:Clinical and Patient-reported Outcomes of Descemet Stripping Automated Endothelial Keratoplasty(DSAEK) Versus Descemet Membrane Endothelial Keratoplasty(DMEK)

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.

Read the detailed description

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.

Being tested
UT-DSAEK, DMEK
Keywords
DMEK, DSAEK, UT-DSAEK
Medical subject headings
Corneal Edema, Fuchs' Endothelial Dystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UT-DSAEKProcedure or surgery

    Also called Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty

    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.

  • DMEKProcedure or surgery

    Also called Descemet Membrane 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.

Study groups in NCT05436665
Study groupRoleWhat they receive
Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK)Active comparatorUltra-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.
Receives: Procedure: UT-DSAEK
Descemet membrane endothelial keratoplasty (DMEK)Active comparatorDescemet 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.
Receives: Procedure: DMEK

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BCVA 12m

    Best-corrected visual acuity expressed in LogMAR

    Measured: 12 months

Secondary outcomes (9)

  1. BCVA 3 and 6m

    Best-corrected visual acuity expressed in LogMAR

    Measured: 3 and 6 months

  2. UCVA 3,6 and12m

    Uncorrected visual acuity expressed in LogMAR

    Measured: 3, 6 and 12 months

  3. Change in refraction

    Change in objective refraction - spectacle correction

    Measured: 3, 6 and 12 months

  4. Proportion of high vision

    Proportion of patients to achieve 0.2 LogMAR visual acuity or less

    Measured: 12 months

  5. 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

    Measured: 3, 6 and 12 months

  6. 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.

    Measured: 3, 6 and 12 months

  7. ECC

    Endothelial cell count

    Measured: 3, 6 and 12 months

  8. CCT

    Central corneal thickness

    Measured: 3, 6 and 12 months

  9. Complications

    Complications associated with the intervention

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2022
  2. Study start10 Aug 2022
  3. Primary completion6 Jan 2028 (estimated)
  4. Study completion6 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
After the patient has been screened and deemed eligible for participation, and the informed consent of the patient has been obtained, the patients will be included in the study. Once the inclusion data is entered by a member of the study personnel into the trial software, allocation of the patient to a treatment arm will take place using minimisation. The allocation will be performed with an equal 1:1 allocation to DSAEK or DMEK with minimisation using the following stratification of participant factors: * Surgical Indication (i.e., Fuchs' endothelial dystrophy and non Fuch's endothelial dystrophy); * Surgical site; * Preoperative visual acuity (Patients with 0.6 LogMAR BCVA or lower (i.e., better vision) and patients with LogMAR BCVA higher than 0.6 LogMAR (i.e., worse vision). The minimisation will be performed by the study team using the online allocation software QMinim.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05436665
Sponsor's protocol ID
UZAntwerpen
Acronym
BESTCornea
Status last verified
Nov 2025
First submitted
23 Jun 2022
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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).

Publications

  • de Bruyn B, Ni Dhubhghaill S, Claerhout I, Claes K, Deconinck A, Delbeke H, Huizing M, Krolo I, Muijzer M, Oellerich S, Roels D, Termote K, Van den Bogerd B, Van Gerwen V, Verhaegen I, Wisse R, Wouters K, Consortium TBC, Duchesne B, Koppen C. Belgian Endothelial Surgical Transplant of the Cornea (BEST cornea) protocol: clinical and patient-reported outcomes of Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) - a multicentric, randomised, parallel group pragmatic trial in corneal endothelial decompensation. BMJ Open. 2023 Sep 15;13(9):e072333. doi: 10.1136/bmjopen-2023-072333.

    PubMed 37714670

Questions about this trial

What is this clinical trial studying?

A study testing UT-DSAEK and DMEK in people with Corneal Edema and Corneal Endothelial Disorder, run by University Hospital, Antwerp at 11 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BCVA 12m (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05436665, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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