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)

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
AZ Imelda
RECRUITING
Bonheiden
AZ Sint-Jan Brugge
RECRUITING
Bruges
Erasmus ziekenhuis Brussel
RECRUITING
Brussels
UZ Brussel
RECRUITING
Brussels
AZ Monica (campus Deurne)
RECRUITING
Deurne
Antwerp University Hospital
RECRUITING
Edegem
Ziekenhuis Oost-Limburg (ZOL)
RECRUITING
Genk
AZ Maria Middelares
RECRUITING
Ghent
UZ Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
CHU Liège
RECRUITING
Liège
Contact Information
Primary
Veerle Van Gerwen, BSc
bestcornea@uza.be
+3238210000
Backup
Axelle Belis, BSc
bestcornea@uza.be
+3238210000
Time Frame
Start Date: 2022-08-10
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 220
Treatments
Active_comparator: Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK)
Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) refers to the use of a corneal endothelial/Descemet graft with a thin layer of stroma (\<110um) attached.~The cornea is made up of 5 layers, all of which work to provide a clear image on the retina. The innermost layer of cells, the endothelium, is responsible for pumping fluid out of the cornea and keeping it transparent: a normal endothelium is essential to keeping the cornea clear. The endothelium lies on a membrane called the Descemet membrane. The thickest layer of the cornea is called the stroma and this provides rigidity and strength to the cornea. When the corneal endothelium fails, it cannot regrow and the best treatment is to replace the cells with healthy donor cells. This is called a corneal endothelial transplantation or endothelial keratoplasty.~In the DSAEK technique, a piece of the donor's endothelium is transplanted with a supporting layer of donor stroma.
Active_comparator: Descemet membrane endothelial keratoplasty (DMEK)
Descemet membrane endothelial keratoplasty refers to the use of a corneal endothelial/Descemet graft with no layer of associated stroma (15-20um thick).~The cornea is made up of 5 layers, all of which work to provide a clear image on the retina. The innermost layer of cells, the endothelium, is responsible for pumping fluid out of the cornea and keeping it transparent: a normal endothelium is essential to keeping the cornea clear. The endothelium lies on a membrane called the Descemet membrane. The thickest layer of the cornea is called the stroma and this provides rigidity and strength to the cornea. When the corneal endothelium fails, it cannot regrow and the best treatment is to replace the cells with healthy donor cells. This is called a corneal endothelial transplantation or endothelial keratoplasty.~In the DMEK technique only a piece of donor endothelium layer is together with its supporting membrane (the Descemet membrane), is transplanted.
Related Therapeutic Areas
Sponsors
Collaborators: Belgium Health Care Knowledge Centre
Leads: University Hospital, Antwerp

This content was sourced from clinicaltrials.gov

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