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

This study is currently recruiting participants.
Verified February 2009 by Netherlands Institute for Innovative Ocular Surgery
Sponsor:
Collaborators:
Amnitrans Eyebank Rotterdam
Melles CorneaClinic Rotterdam
Information provided by:
Netherlands Institute for Innovative Ocular Surgery
ClinicalTrials.gov Identifier:
NCT00543660
First received: October 11, 2007
Last updated: February 3, 2009
Last verified: February 2009
History of Changes
  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:

U.S. FDA Resources

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)
Intervention Details:
    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
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:
(NIIOS technique - Descemet Membrane Endothelial Keratoplasty (DMEK))  This link exits the ClinicalTrials.gov site
(NIIOS technique - Descemet Stripping Endothelial Keratoplasty (DSEK))  This link exits the ClinicalTrials.gov site
(NIIOS technique - Deep Lamellar Endothelial Keratoplasty (DLEK) - Small incision)  This link exits the ClinicalTrials.gov site
(NIIOS technique - Deep Lamellar Endothelial Keratoplasty (DLEK))  This link exits the ClinicalTrials.gov site
(Descemet Stripping Automated Endothelial Keratoplasty (DSAEK))  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: G. Melles, NIIOS
ClinicalTrials.gov Identifier: NCT00543660     History of Changes
Other Study ID Numbers: NIIOS.1998.04
Study First Received: October 11, 2007
Last Updated: February 3, 2009
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 May 19, 2013