TDSAEK versus DMEK
Recruiting
- Conditions
- Fuchs’ endothelial dystrophy
- Registration Number
- NL-OMON23947
- Lead Sponsor
- The Rotterdam Eye Hospital
- 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
- 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 Best corrected visual acuity (BCVA) at 12 months
- Secondary Outcome Measures
Name Time Method BCVA at baseline and at 1, 3, 6 months postoperatively<br>Number of graft detachments, rebubbling procedures or graft failures<br>Endothelial cell density at 1 and 12 months<br>Contrast sensitivity at baseline and at 12 months<br>Root mean square of Zernike polynomials of high order aberrations