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Descemet Membrane Endothelial Keratoplasty (DMEK) (DMEK)

This study is currently recruiting participants.
Verified June 2015 by GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery
Sponsor:
ClinicalTrials.gov Identifier:
NCT00521898
First Posted: August 28, 2007
Last Update Posted: June 3, 2015
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Amnitrans Eyebank Rotterdam
Information provided by (Responsible Party):
GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery
  Purpose
To evaluate isolated Descemet membrane transplantation as a refinement of previous advanced techniques for corneal transplantation, like Descemet Stripping Endothelial Keratoplasty (DSEK)

Condition Intervention
Corneal Dystrophies, Hereditary Procedure: Descemet Membrane Endothelial Keratoplasty (DMEK)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Clinical Study on Descemet Membrane Endothelial Keratoplasty (DMEK)

Resource links provided by NLM:


Further study details as provided by GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery:

Primary Outcome Measures:
  • Best spectacle corrected visual acuity [ Time Frame: 2005-2015 ]

Secondary Outcome Measures:
  • Corneal endothelial cell density [ Time Frame: 2005-2015 ]

Estimated Enrollment: 100
Study Start Date: February 2005
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DMEK
DMEK as intervention
Procedure: Descemet Membrane Endothelial Keratoplasty (DMEK)

Detailed Description:
See above.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Corneal endothelial disorders

Exclusion Criteria:

  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): NCT00521898


Contacts
Contact: Gerrit R Melles, MD, PhD +31 10 297 4444 melles@niioc.nl

Locations
Netherlands
Netherlands Institute for Innovative Ocular Surgery Recruiting
Rotterdam, Netherlands, 3071 AA
Contact: Kim Herders, MSc         
Principal Investigator: Gerrit R Melles, MD, PhD         
Sub-Investigator: Jacqueline Wees, PhD         
Sponsors and Collaborators
Netherlands Institute for Innovative Ocular Surgery
Amnitrans Eyebank Rotterdam
Investigators
Principal Investigator: Gerrit R Melles, MD, PhD Netherlands Institute for Innovative Ocular Surgery
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GRJ Melles, MD, PhD, Institute Director, Netherlands Institute for Innovative Ocular Surgery
ClinicalTrials.gov Identifier: NCT00521898     History of Changes
Other Study ID Numbers: NIIOS.2005.14
First Submitted: August 24, 2007
First Posted: August 28, 2007
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery:
Corneal transplantation, Descemet membrane

Additional relevant MeSH terms:
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn