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| Name | Class |
|---|---|
| Belgium Health Care Knowledge Centre | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) | Active Comparator | 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. |
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| Descemet membrane endothelial keratoplasty (DMEK) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UT-DSAEK | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA 12m | Best-corrected visual acuity expressed in LogMAR | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA 3 and 6m | Best-corrected visual acuity expressed in LogMAR | 3 and 6 months |
| UCVA 3,6 and12m | Uncorrected visual acuity expressed in LogMAR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veerle Van Gerwen, BSc | Contact | +3238210000 | 5271 | bestcornea@uza.be |
| Axelle Belis, BSc | Contact | +3238210000 | 2466 | bestcornea@uza.be |
| Name | Affiliation | Role |
|---|---|---|
| Sorcha Ni Dhubhghaill, MBBCh, PhD | Universitair Ziekenhuis Brussel | Study Director |
| Carina Koppen, MD, PhD | University Hospital, Antwerp | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Recruiting | Edegem | Antwerp | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37714670 | Derived | 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. |
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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).
The article with regards to the study protocol is now under revision in an open acces medical journal.
The article with regards to the study protocol will be published in an open access medical journal.
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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:
The minimisation will be performed by the study team using the online allocation software QMinim.
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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.
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| DMEK | Procedure | 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. |
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| 3, 6 and 12 months |
| Change in refraction | Change in objective refraction - spectacle correction | 3, 6 and 12 months |
| Proportion of high vision | Proportion of patients to achieve 0.2 LogMAR visual acuity or less | 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 | 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. | 3, 6 and 12 months |
| ECC | Endothelial cell count | 3, 6 and 12 months |
| CCT | Central corneal thickness | 3, 6 and 12 months |
| Complications | Complications associated with the intervention | 12 months |
| Bernard Duchesne, MD, PhD |
| University Hospital Liege |
| Study Chair |
| AZ Maria Middelares | Recruiting | Ghent | Oost-Vlaanderen | Belgium |
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| AZ Sint-Jan Brugge | Recruiting | Bruges | West-Vlaanderen | Belgium |
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| AZ Imelda | Recruiting | Bonheiden | Belgium |
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| Erasmus ziekenhuis Brussel | Recruiting | Brussels | Belgium |
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| UZ Brussel | Recruiting | Brussels | Belgium |
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| AZ Monica (campus Deurne) | Recruiting | Deurne | Belgium |
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| Ziekenhuis Oost-Limburg (ZOL) | Recruiting | Genk | Belgium |
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| UZ Gent | Recruiting | Ghent | Belgium |
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| UZ Leuven | Recruiting | Leuven | Belgium |
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| CHU Liège | Recruiting | Liège | Belgium |
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| ID | Term |
|---|---|
| D015715 | Corneal Edema |
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D003317 | Corneal Dystrophies, Hereditary |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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