A Randomized, Comparative Trial of Two Posterior Lamellar Keratoplasty Techniques. Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK).
Suspended
- Conditions
- Fuchs'endothelial dysthrophyand indication for keratoplasty
- Registration Number
- NL-OMON24220
- Lead Sponsor
- The Rotterdam Eye HospitalPO Box 700303000 LM Rotterdam010- 401 77 77
- Brief Summary
ot Applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of letters gained at 12 months.
- Secondary Outcome Measures
Name Time Method ogMAR Best Corrected Visual Acuity (BCVA) at 1, 3, 6, 12 months.<br>Rate of LogMAR BCVA recovery in both groups (RMANOVA).<br>Contrast sensitivity and stray light at 1, 3, 6 and 12 months.<br>RMS (root mean square) of Zernike polynomials of total high order aberrations.<br>Quality of vision questionnaire at 1, 3, 6 and 12 months.<br>Endothelial cell density of the grafts at 6 and 12 months.<br>Number of graft detachments.<br>Number of graft failures.<br>OT time and costs.<br>