The Belgian Endothelial Surgical Transplant of the Cornea
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)
University Hospital, Antwerp
220 participants
Aug 10, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria9
- 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);
- 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.
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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.
Locations(11)
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NCT05436665