To demonstrate that DMEK is superior to DSAEK with respect to VA.
ID
Source
Brief title
Condition
- Ocular structural change, deposit and degeneration 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 1, 3, 6, 12 months.
Rate of vision recovery.
Contrast sensitivity and stray light at 1, 3, 6 and 12 months.
RMS (root mean square) of Zernike polynomials of total high order aberrations.
Quality of vision questionnaire at 1, 3, 6 and 12 months.
Endothelial cell density of the grafts at 6 and 12 months.
Number of graft detachments.
Number of graft failures.
OT time and costs.
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 VA.
Study design
Randomised, comparative.
Intervention
UTDSAEK or DMEK.
Study burden and risks
The outcome of DMEK may be more favorable but the risk of detachment is higher.
Assessments for this study are non-invasive and inconvenience is negligible,
extra time required is approximately 1 hour per visit (5X).
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).
Exclusion criteria
Unable to attend the FU visits.
Previous keratoplasty in the eye to be included.
Severe progressive glaucoma (stable glaucoma on topical therapy is excepted).
History of retinal surgery, glaucoma surgery or age related macular disease.
Amblyopia.
Expected postoperative VA < 0.6.
Corneal neovascularisation > 1 quadrant.
Indication for typed graft.
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 | NL50956.078.14 |