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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
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.
Antwerp University Hospital
Edegem, Antwerp, Belgium
RECRUITINGAZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
RECRUITINGAZ Sint-Jan Brugge
Bruges, West-Vlaanderen, Belgium
RECRUITINGAZ Imelda
Bonheiden, Belgium
RECRUITINGErasmus ziekenhuis Brussel
Brussels, Belgium
RECRUITINGUZ Brussel
Brussels, Belgium
RECRUITINGAZ Monica (campus Deurne)
Deurne, Belgium
RECRUITINGZiekenhuis Oost-Limburg (ZOL)
Genk, Belgium
RECRUITINGUZ Gent
Ghent, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITING...and 1 more locations
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
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