A Randomized, Comparative Trial of Two Posterior Lamellar Keratoplasty Techniques. Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK)
Recruiting
- Conditions
- Fuchs endothelial dystrophy10015917
- Registration Number
- NL-OMON49409
- Lead Sponsor
- Oogziekenhuis Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 96
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number of letters gained at 12 months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>LogMAR Best Corrected Visual Acuity (BCVA) at baseline and at 1, 3, 6, 12<br /><br>months.<br /><br>Rate of LogMAR BCVA recovery.<br /><br>Number of graft detachments / rebubling procedures.<br /><br>Number of graft failures.<br /><br>Endothelial cell density at 1 and 12 months.<br /><br>Contrast sensitivity at baseline and 12 months.<br /><br>RMS Zernike polynomials.<br /><br>Quality of vision at baseline and at 12 months.<br /><br>OT time.</p><br>