The objective of this trial is to assess the effects and costs of DMEK vs. DSAEK in order to determine whether the new technique is effective and cost-effective over the standard technique.
ID
Source
Brief title
Condition
- Vision disorders
- Eye therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is best-corrected visual acuity.
Secondary outcome
Secondary outcome measures are contrast acuity, astigmatism, quality of vision,
endothelial cell loss, incidence of graft rejection, primary graft failure,
cornea donor loss due to preparation, and generic and vision-related quality of
life.
Background summary
Corneal transplantation improves vision and quality of life in patients with
corneal disease. Currently, the standard of care for patients with Fuchs
Endothelial Corneal Dystrophy (FECD) is Descemet Stripping Automated
Endothelial Keratoplasty (DSAEK), in which only the posterior layers of the
cornea are transplanted. However, visual recovery following DSAEK is
suboptimal. Descemet Membrane Endothelial Keratoplasty (DMEK), the latest
technique in corneal transplantation involves transplantation of only a
monolayer of corneal endothelium and Descemet*s membrane providing the thinnest
endothelial graft possible. DMEK has been suggested to result in faster and
better visual recovery compared to DSAEK. However, this is based on limited
evidence, underscoring the need for a randomized controlled trial (RCT).
Study objective
The objective of this trial is to assess the effects and costs of DMEK vs.
DSAEK in order to determine whether the new technique is effective and
cost-effective over the standard technique.
Study design
Multi-center, prospective, randomized, controlled, single- blinded,
interventional clinical trial.
Intervention
The intervention group will receive cornea transplantation by DMEK. The usual
care / control group will receive cornea transplantation by DSAEK.
Study burden and risks
Measurements and examinations are performed before and 3, 6 and 12 months after
the intervention. Some of the examinations are not part of standard care, but
similar to all of the other examinations they are non-invasive, have no side
effects and take a few minutes to perform. In addition, patients will be asked
to fill in quality-of-life questionnaires and cost questionnaires.
We believe that DMEK patients will benefit from the study because visual
outcomes are expected to be better in these patients. Based on the literature,
DMEK is not associated with any health risks additional to those associated
with DSAEK (standard care).
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Irreversible cornea decompensation caused by Fuchs Corneal Endothelial Dystrophy
- A minimum patient age of 21
Exclusion criteria
- Ocular comorbities other than cataract
- Previous corneal transplantation
- Human leukocyte antigen (HLA) matched keratoplasty
- Inability to complete follow-up
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55972.068.15 |
| Other | nog niet bekend. |