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Descemet Membrane Endothelial Keratoplasty (DMEK) (DMEK)

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ClinicalTrials.gov Identifier: NCT00521898
Recruitment Status : Recruiting
First Posted : August 28, 2007
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
Amnitrans Eyebank Rotterdam
Information provided by (Responsible Party):
GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery

Brief Summary:
To evaluate isolated Descemet membrane transplantation as a refinement of previous advanced techniques for corneal transplantation, like Descemet Stripping Endothelial Keratoplasty (DSEK)

Condition or disease Intervention/treatment
Corneal Dystrophies, Hereditary Procedure: Descemet Membrane Endothelial Keratoplasty (DMEK)

Detailed Description:
See above.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Clinical Study on Descemet Membrane Endothelial Keratoplasty (DMEK)
Study Start Date : February 2005
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: DMEK
DMEK as intervention
Procedure: Descemet Membrane Endothelial Keratoplasty (DMEK)



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

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


Information from the National Library of Medicine

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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:


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

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 Posted: August 28, 2007    Key Record Dates
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