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.
Fuchs Endothelial Dystrophy (FED);
Bullous Keratopathy (BK);
Other miscellaneous causes of endothelial dysfunction including decompensation of a previous corneal graft;
Pseudophakic (post cataract surgery);
Inability to provide informed consent;
Patients unable to attend the proposed follow up;
Inclusion of the fellow eye in the study;
Complex surgery combined with multiple pathologies (i.e., glaucoma surgery);
Parallel
UT-DSAEK
Procedure/SurgeryThe 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.
DMEK
Procedure/SurgeryThe 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.
BCVA 12m
Best-corrected visual acuity expressed in LogMAR
BCVA 3 and 6m
Best-corrected visual acuity expressed in LogMAR
UCVA 3,6 and12m
Uncorrected visual acuity expressed in LogMAR
Change in refraction
Change in objective refraction - spectacle correction
Proportion of high vision
Proportion of patients to achieve 0.2 LogMAR visual acuity or less
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University Hospital, Antwerp
Lead sponsor
Belgium Health Care Knowledge Centre
Collaborator
