To evaluate long term results of DSEK and to compare pre- and postoperative quality of vision in patients with Fuchs' endothelial dystrophy.
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Evaluation of the long term clinical results of DSEK: what is the
improvement in quality of vision as compared to the pre-operative situation?
2) Correlation of the endothelial cell count, keratometry and corneal and
posterior transplant thickness with the improvement in quality of vision.
Secondary outcome
not applicable
Background summary
Descemet-stripping endothelial keratoplasty (DSEK) is a relatively new surgical
treatment for Fuchs' endothelial dystrophy. Fuchs* endothelial dystrophy is a
common inheritable disorder leading to a slow loss of corneal endothelial
cells. As these cells can't divide, the lost cells will not be replaced.
Patients with advanced Fuchs' endothelial dystrophy often complain of
deterioration of visual acuity, glare and haloes. They can also suffer from
irritation and even pain. There are not many options for medical treatment.
Till a few years ago, corneal transplantation was the only available
therapeutic option for this group of patients.
DSEK was first described in 1998 and is performed in the AMC since 2001.
Currently, it is a universally accepted surgical technique. The main difference
with penetrating keratoplasty is that only the diseased posterior lamella of
the cornea is replaced (consisting of the posterior stroma, Descemet's membrane
and the endothelium). Major advantages of replacing only the posterior part of
the cornea are: less intraoperative complications, no suture related problems
(as no sutures are used), no irregular astigmatism, a less vulnerable wound and
less risk of rejection. However, long term results of DSEK are not known yet.
Study objective
To evaluate long term results of DSEK and to compare pre- and postoperative
quality of vision in patients with Fuchs' endothelial dystrophy.
Study design
It is an observational cohort study.
Pre- and postoperatively quality of vision will be evaluated by:
- documentation of subjective complaints with a validated questionnaire, the
VFQ-25
- measurement of best corrected visual acuity
- straylight measurement
- orbscan measurement to determine thickness and keratometry of the cornea
- endothelial cell count
- anterior segment OCT measurement
All examinations are non-invasive and non-contact and without any risk for the
patients.
Study burden and risks
The patients will make one to two study visit to the Department of
Ophthalmology, lasting between 2 and 3 hours. The measurements will pose no
extra risk for the patients.
Meibergdreef 47
1105 BA Amsterdam
Nederland
Meibergdreef 47
1105 BA Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1) Fuchs' endothelial dystrophy; either unoperated patients or after PLK
2) Able and willing to participate in the study and to understand and sign the informed consent form
Exclusion criteria
1) Patients with Fuchs' endothelial dystrophy and other opthalmological conditions which can influence quality of vision
2) Not able or unwilling to participate in the study or to understand and sign the informed consent form
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 | NL23685.018.08 |