Clinical Trial: Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Prospective Clinical Study on Postoperative Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Brief Summary: The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.
Detailed Summary:
Sponsor: Charite University, Berlin, Germany
Current Primary Outcome: Visual acuity (change from baseline) [ Time Frame: 1, 3, 6, and 12 months and annually ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Endothelial cell density (change from baseline) [ Time Frame: 1, 3, 6, and 12 months and annually ]
- Intraocular pressure (change from baseline) [ Time Frame: 1, 3, 6, and 12 months and annually ]
- Manifest refraction (change from baseline) [ Time Frame: 1, 3, 6, 12 months and annually ]
- corneal pachymetry (change from baseline) [ Time Frame: 1, 3, 6, 12 months and annually ]
- Quality of Life, NEI-VFQ 25 (change from baseline) [ Time Frame: 3, 12 months, annualy ]Questionnaire
- corneal topography (change from baseline) [ Time Frame: 1, 3, 6, and 12 months and annually ]
- Anterior Segment OCT of cornea and anterior chamber angle (change from baseline) [ Time Frame: 1, 3, 6, and 12 months and annually ]
- postoperative Medication (change from baseline) [ Time Frame: 1,3,6 and 12 months and annually ]
- Histological Sample of Recipient's Descemet Membrane [ Time Frame: intraoperative ]Recipient's Descemet Membrane
Original Secondary Outcome: Same as current
Information By: Charite University, Berlin, Germany
Dates:
Date Received: December 11, 2013
Date Started: September 2012
Date Completion:
Last Updated: December 18, 2013
Last Verified: December 2013
