The Belgian Endothelial Surgical Transplant of the Cornea
BESTCornea
1 other identifier
interventional
220
1 country
11
Brief 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. the purpose is to compare the clinical and patient reported outcomes of both therapies across a broad range of indications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedStudy Start
First participant enrolled
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
November 25, 2025
November 1, 2025
4.6 years
June 23, 2022
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BCVA 12m
Best-corrected visual acuity expressed in LogMAR
12 months
Secondary Outcomes (9)
BCVA 3 and 6m
3 and 6 months
UCVA 3,6 and12m
3, 6 and 12 months
Change in refraction
3, 6 and 12 months
Proportion of high vision
12 months
EQ-5D-5L
3, 6 and 12 months
- +4 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Inability to provide informed consent;
- Patients unable to attend the proposed follow up;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Antwerplead
- Belgium Health Care Knowledge Centrecollaborator
Study Sites (11)
Antwerp University Hospital
Edegem, Antwerp, 2650, Belgium
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
AZ Sint-Jan Brugge
Bruges, West-Vlaanderen, Belgium
AZ Imelda
Bonheiden, Belgium
Erasmus ziekenhuis Brussel
Brussels, Belgium
UZ Brussel
Brussels, Belgium
AZ Monica (campus Deurne)
Deurne, Belgium
Ziekenhuis Oost-Limburg (ZOL)
Genk, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
CHU Liège
Liège, Belgium
Related Publications (1)
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.
PMID: 37714670DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sorcha Ni Dhubhghaill, MBBCh, PhD
Universitair Ziekenhuis Brussel
- STUDY CHAIR
Carina Koppen, MD, PhD
University Hospital, Antwerp
- STUDY CHAIR
Bernard Duchesne, MD, PhD
University Hospital Liege
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Due to the nature of the study, the treating surgeons will be unblinded to the graft type. The outcomes will be assess by a blinded assessor and the quality of life questionnaires will be completed by the patient themselves, with assistance from the blinded assessor as needed.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2022
First Posted
June 29, 2022
Study Start
August 10, 2022
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- 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.
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).