220
Participants
Start Date
August 10, 2022
Primary Completion Date
July 1, 2026
Study Completion Date
July 1, 2026
UT-DSAEK
"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."
DMEK
"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."
RECRUITING
Antwerp University Hospital, Edegem
RECRUITING
AZ Maria Middelares, Ghent
RECRUITING
AZ Sint-Jan Brugge, Bruges
RECRUITING
AZ Imelda, Bonheiden
RECRUITING
Erasmus ziekenhuis Brussel, Brussels
RECRUITING
UZ Brussel, Brussels
RECRUITING
AZ Monica (campus Deurne), Deurne
RECRUITING
Ziekenhuis Oost-Limburg (ZOL), Genk
RECRUITING
UZ Gent, Ghent
RECRUITING
UZ Leuven, Leuven
RECRUITING
CHU Liège, Liège
Belgium Health Care Knowledge Centre
OTHER_GOV
University Hospital, Antwerp
OTHER