The objective of this project is to assess the effects and costs of ultra-thin DSAEK vs. standard 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
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 predominant technique for patients with corneal
endothelial disease is Descemet Stripping Automated Endothelial Keratoplasty
(DSAEK), in which only the posterior side of the cornea is transplanted.
However, visual rehabilitation after DSAEK may be variable. In ultra-thin
DSAEK, the donor tissue is thinner, which may result in better visual outcomes
and, consequently, a better quality of life.
Study objective
The objective of this project is to assess the effects and costs of ultra-thin
DSAEK vs. standard DSAEK in order to determine whether the new technique is
effective and cost-effective over the standard technique.
Study design
Multicenter randomized clinical trial.
Intervention
The intervention consists of the performance of standard DSAEK (grafts of
approximately 200 microns) or ultra-thin DSAEK (grafts of approximately 75
microns).
Study burden and risks
Measurements and examinations are performed before and 3, 6 and 12 months after
the intervention. Normally, most of the examinations are not performed at 3
months. All other measurements are part of the standard of care in corneal
transplantation. All examinations 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 ultra-thin DSAEK patients will benefit from the study because
visual outcomes are expected to be better in these patients.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Endothelial dysfunction caused by pseudophakic or aphakic corneal edema, (Fuchs*) endothelial dystrophy, a minimum patient age of 18 years, and best spectacle-corrected visual acuity (BSCVA) lower than 20/50.
Exclusion criteria
Previous corneal transplantation, human leukocyte antigen typed keratoplasty, and patients who are unable to communicate properly or to understand instructions.
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 | NL38365.068.11 |