Trial record 4 of 25 for:    "lattice corneal dystrophy type I" OR "Corneal Dystrophies, Hereditary"

Descemet Membrane Endothelial Keratoplasty (DMEK)

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 August 21, 2014