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

This study is currently recruiting participants.
Verified June 2015 by GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery
Sponsor:
ClinicalTrials.gov Identifier:
NCT00543660
First Posted: October 15, 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.
Collaborators:
Amnitrans Eyebank Rotterdam
Melles CorneaClinic Rotterdam
Information provided by (Responsible Party):
GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)

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: 1998 - 2018 ]

Secondary Outcome Measures:
  • Corneal endothelial cell density [ Time Frame: 1998-2018 ]

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)
  • Please see www.niios.com

Detailed Description:
Please 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): 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

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
First Submitted: October 11, 2007
First Posted: October 15, 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, endothelium

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