NCT02020044
Unknown
Not Applicable
Prospective Clinical Study on Postoperative Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fuchs' Endothelial Corneal Dystrophy
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Visual acuity (change from baseline)
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.
Investigators
Necip Torun
Necip, Torun, MD
Charite University, Berlin, Germany
Eligibility Criteria
Inclusion Criteria
- •Male or female aged 18 or older
- •Scheduled to undergo endothelial keratoplasty
- •Able to provide written informed consent.
Exclusion Criteria
- •Age less than 18 years
Outcomes
Primary Outcomes
Visual acuity (change from baseline)
Time Frame: 1, 3, 6, and 12 months and annually
Secondary Outcomes
- Endothelial cell density (change from baseline)(1, 3, 6, and 12 months and annually)
- Intraocular pressure (change from baseline)(1, 3, 6, and 12 months and annually)
- Manifest refraction (change from baseline)(1, 3, 6, 12 months and annually)
- corneal pachymetry (change from baseline)(1, 3, 6, 12 months and annually)
- Quality of Life, NEI-VFQ 25 (change from baseline)(3, 12 months, annualy)
- corneal topography (change from baseline)(1, 3, 6, and 12 months and annually)
- Anterior Segment OCT of cornea and anterior chamber angle (change from baseline)(1, 3, 6, and 12 months and annually)
- postoperative Medication (change from baseline)(1,3,6 and 12 months and annually)
- Histological Sample of Recipient's Descemet Membrane(intraoperative)
Study Sites (1)
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