Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Necip Torun, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT02020044
First received: December 11, 2013
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.


Condition Intervention
Fuchs' Endothelial Corneal Dystrophy
Bullous Keratopathy
Iridocorneal Endothelial Syndrome
Posterior Polymorphous Dystrophy
Endothelial Dysfunction
Other: Endothelial Keratoplasty

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Clinical Study on Postoperative Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Visual acuity (change from baseline) [ Time Frame: 1, 3, 6, and 12 months and annually ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial cell density (change from baseline) [ Time Frame: 1, 3, 6, and 12 months and annually ] [ Designated as safety issue: No ]
  • Intraocular pressure (change from baseline) [ Time Frame: 1, 3, 6, and 12 months and annually ] [ Designated as safety issue: No ]
  • Manifest refraction (change from baseline) [ Time Frame: 1, 3, 6, 12 months and annually ] [ Designated as safety issue: No ]
  • corneal pachymetry (change from baseline) [ Time Frame: 1, 3, 6, 12 months and annually ] [ Designated as safety issue: No ]
  • Quality of Life, NEI-VFQ 25 (change from baseline) [ Time Frame: 3, 12 months, annualy ] [ Designated as safety issue: No ]
    Questionnaire

  • corneal topography (change from baseline) [ Time Frame: 1, 3, 6, and 12 months and annually ] [ Designated as safety issue: No ]
  • Anterior Segment OCT of cornea and anterior chamber angle (change from baseline) [ Time Frame: 1, 3, 6, and 12 months and annually ] [ Designated as safety issue: No ]
  • postoperative Medication (change from baseline) [ Time Frame: 1,3,6 and 12 months and annually ] [ Designated as safety issue: No ]
  • Histological Sample of Recipient's Descemet Membrane [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    Recipient's Descemet Membrane


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Endothelial Keratoplasty
Descemet membrane endothelial keratoplasty DMEK Ultra-thin Descemet stripping automated endothelial keratoplasty Ultra-thin DSAEK
Other: Endothelial Keratoplasty
Other Names:
  • DMEK
  • Descemet Membrane Endothelial Keratoplasty
  • Ultra-thin Descemet stripping automated endothelial keratoplasty
  • Ultra-thin DSAEK

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020044

Contacts
Contact: Anna-Karina Maier, MD anna-karina.maier@charite.de

Locations
Germany
Department of Ophthalmology, Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Anna-Karina Maier, MD    +4930450654419    anna-karina.maier@charite.de   
Principal Investigator: Anna-Karina Maier, MD         
Principal Investigator: Necip Torun, MD         
Sub-Investigator: Johannes Gonnermann, MD         
Sub-Investigator: Mathias KJ Klamann, MD         
Sub-Investigator: Tobias Brockmann, MD         
Sub-Investigator: Enken Gundlach, MD         
Sub-Investigator: Christian Eulufi, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Necip Torun, MD Department of Ophthalmology, Charité - Unviersitätsmedizin Berlin
  More Information

Publications:
Responsible Party: Necip Torun, Necip, Torun, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02020044     History of Changes
Other Study ID Numbers: EA2/108/12
Study First Received: December 11, 2013
Last Updated: December 18, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Corneal Dystrophies, Hereditary
Fuchs' Endothelial Dystrophy
Iridocorneal Endothelial Syndrome
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Iris Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on August 21, 2014