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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Necip Torun, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02020044
First Posted: December 24, 2013
Last Update Posted: December 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Necip Torun, Charite University, Berlin, Germany
  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: None (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 Necip Torun, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Visual acuity (change from baseline) [ Time Frame: 1, 3, 6, and 12 months and annually ]

Secondary Outcome Measures:
  • 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


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: December 11, 2013
First Posted: December 24, 2013
Last Update Posted: December 24, 2013
Last Verified: December 2013

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