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RECRUITING
NCT05436665
NA

The Belgian Endothelial Surgical Transplant of the Cornea

Sponsor: University Hospital, Antwerp

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2022-08-10

Completion Date

2028-06-06

Last Updated

2026-04-03

Healthy Volunteers

No

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.

Locations (11)

Antwerp University Hospital

Edegem, Antwerp, Belgium

AZ Maria Middelares

Ghent, Oost-Vlaanderen, Belgium

AZ Sint-Jan Brugge

Bruges, West-Vlaanderen, Belgium

AZ Imelda

Bonheiden, Belgium

Erasmus ziekenhuis Brussel

Brussels, Belgium

UZ Brussel

Brussels, Belgium

AZ Monica (campus Deurne)

Deurne, Belgium

Ziekenhuis Oost-Limburg (ZOL)

Genk, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

CHU Liège

Liège, Belgium