The Belgian Endothelial Surgical Transplant of the Cornea

NARecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

August 10, 2022

Primary Completion Date

July 1, 2026

Study Completion Date

July 1, 2026

Conditions
Corneal EdemaCorneal Endothelial DisorderFuchs' Endothelial DystrophyBullous KeratopathyPseudophakic Bullous Keratopathy
Interventions
PROCEDURE

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."

PROCEDURE

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."

Trial Locations (11)

2650

RECRUITING

Antwerp University Hospital, Edegem

Unknown

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

All Listed Sponsors
collaborator

Belgium Health Care Knowledge Centre

OTHER_GOV

lead

University Hospital, Antwerp

OTHER