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A Randomized, Comparative Trial of Two Posterior Lamellar Keratoplasty Techniques. Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK).


- candidate number21159
- NTR NumberNTR4945
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-dec-2014
- Secondary IDsOZR 2014-20 NL50956.078.14
- Public TitleA Randomized, Comparative Trial of Two Posterior Lamellar Keratoplasty Techniques. Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK).
- Scientific TitleA Randomized, Comparative Trial of Two Posterior Lamellar Keratoplasty Techniques. Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK).
- ACRONYM
- hypothesisDMEK is superior to DSAEK in terms of (rate of) VA rehabilitation.
- Healt Condition(s) or Problem(s) studiedFuchs'endothelial dysthrophy, keratoplasty
- Inclusion criteria- Age ≥ 18 years - Informed consent. - Fuchs endothelial dystrophy. - VA < 0.6 (Snellen).
- Exclusion criteriaUnable 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2015
- planned closingdate1-jun-2017
- Target number of participants40
- InterventionsUltrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK) Descemet Stripping Automated Endothelial Keratoplasty (DMAEK)
- Primary outcomeNumber of letters gained at 12 months.
- Secondary outcomeLogMAR Best Corrected Visual Acuity (BCVA) at 1, 3, 6, 12 months. Rate of LogMAR BCVA recovery in both groups (RMANOVA). 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.
- Timepointsbaseline, 1,3,6,12 month
- Trial web site
- statusstopped
- CONTACT FOR PUBLIC QUERIESophthalmologist J van Rooij
- CONTACT for SCIENTIFIC QUERIESophthalmologist J van Rooij
- Sponsor/Initiator The Rotterdam Eye Hospital
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsNot Applicable
- Brief summaryRationale: 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. Objective: To demonstrate that DMEK is superior to DSAEK with respect to VA. Study design: Randomised, comparative. Study population: Patients with FED indicated for keratoplasty. Intervention: UTDSAEK or DMEK. Main study parameters/endpoints: Number of letters gained at 12 months. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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).
- Main changes (audit trail)
- RECORD15-dec-2014 - 22-okt-2017


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