To demonstrate that DMEK is superior to DSAEK with respect to visual acuity and quality of vision.
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of letters gained at 12 months.
Secondary outcome
LogMAR Best Corrected Visual Acuity (BCVA) at baseline and at 1, 3, 6, 12
months.
Rate of LogMAR BCVA recovery.
Number of graft detachments / rebubling procedures.
Number of graft failures.
Endothelial cell density at 1 and 12 months.
Contrast sensitivity at baseline and 12 months.
RMS Zernike polynomials.
Quality of vision at baseline and at 12 months.
OT time.
Background summary
With advanced stages of Fuchs* endothelial dystrophy (FED), keratoplasty is the
only manner to restore vision. Although lamellar techniques, nowadays, are
generally prefered, there is an ongoing debate whether Ultrathin Descemet
Stripping Automated Endothelial Keratoplasty (UTDSAEK) or Descemet Membrane
Endothelial Keratoplasty (DMEK) should be the procedure of choice in FED.
Study objective
To demonstrate that DMEK is superior to DSAEK with respect to visual acuity and
quality of vision.
Study design
Randomised, comparative.
Intervention
UTDSAEK or DMEK.
Study burden and risks
The outcome of DMEK may be more favourable but the technique is challenging and
the risk of graft detachment may be higher. Assessments for this study are
non-invasive and inconvenience is negligible, extra time required is maximally
1 hour per visit (5X; total time 4 h).
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
Age >= 18 years.
Informed consent.
Fuchs* endothelial dystrophy.
VA < 0.6 (Snellen).
Pseudophakia.
Exclusion criteria
Previous keratoplasty in the eye to be included.
Severe progressive glaucoma.
History of retinal surgery, glaucoma surgery or age related macular disease.
Amblyopia.
Expected postoperative VA < 0.6.
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 | NL73183.078.20 |
| Other | NL8938 |