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Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Netherlands Institute for Innovative Ocular Surgery
Sponsor:
Collaborators:
Amnitrans Eyebank Rotterdam
Melles CorneaClinic Rotterdam
Information provided by (Responsible Party):
GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery
ClinicalTrials.gov Identifier:
NCT00543660
First received: October 11, 2007
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

To evaluate the transplantation of a posterior corneal disc for the management of corneal endothelial disorders in Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet Stripping Automated Endothelial Keratoplasty (DSAEK).


Condition Intervention
Corneal Dystrophies, Hereditary
Procedure: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

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: 1998 - 2018 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Corneal endothelial cell density [ Time Frame: 1998-2018 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: March 1998
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention arm DSEK
Intervention: DSEK
Procedure: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Other Names:
  • Descemet Stripping Endothelial Keratoplasty (DSEK)
  • Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
  • Please see www.niios.com

Detailed Description:

Please 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: NCT00543660

Contacts
Contact: Gerrit RJ Melles, MD PhD 31 10 297 4444 melles@niioc.nl
Contact: Kim Herders, MSc 31 10 297 4444 herders@niios.com

Locations
Netherlands
Netherlands Institute for Innovative Ocular Surgery Recruiting
Rotterdam, Netherlands, 3071 AA
Contact: Kim Herders, MSc    31 10 297 4444    herders@niios.com   
Sub-Investigator: Lisanne Ham, MSc         
Sub-Investigator: Jacqueline van der Wees, PhD         
Principal Investigator: Gerrit RJ Melles, MD PhD         
Sponsors and Collaborators
Netherlands Institute for Innovative Ocular Surgery
Amnitrans Eyebank Rotterdam
Melles CorneaClinic Rotterdam
Investigators
Principal Investigator: Gerrit RJ Melles, MD PhD Netherlands Institute for Innovative Ocular Surgery
  More Information

Additional Information:
Publications:
Responsible Party: GRJ Melles, MD, PhD, Director, Netherlands Institute for Innovative Ocular Surgery
ClinicalTrials.gov Identifier: NCT00543660     History of Changes
Other Study ID Numbers: NIIOS.1998.04
Study First Received: October 11, 2007
Last Updated: October 22, 2014
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Netherlands Institute for Innovative Ocular Surgery:
Corneal transplantation, Descemet membrane, endothelium

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

ClinicalTrials.gov processed this record on November 25, 2014