Descemet Membrane Endothelial Keratoplasty (DMEK)

This study is currently recruiting participants.
Verified October 2012 by Netherlands Institute for Innovative Ocular Surgery
Sponsor:
Collaborator:
Amnitrans Eyebank Rotterdam
Information provided by (Responsible Party):
GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery
ClinicalTrials.gov Identifier:
NCT00521898
First received: August 24, 2007
Last updated: October 30, 2012
Last verified: October 2012
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Netherlands Institute for Innovative Ocular Surgery:

Primary Outcome Measures:
  • Best spectacle corrected visual acuity [ Time Frame: 2005-2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Corneal endothelial cell density [ Time Frame: 2005-2015 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2005
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Detailed Description:

See above.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Corneal endothelial disorders

Exclusion Criteria:

  • N/A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Additional 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
Study First Received: August 24, 2007
Last Updated: October 30, 2012
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on April 23, 2014