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Clinical Trials/NCT02020044
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)

Charite University, Berlin, Germany1 site in 1 country200 target enrollmentSeptember 2012

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
December 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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