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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 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: June 2, 2015
Last verified: June 2015

October 11, 2007
June 2, 2015
March 1998
March 2018   (final data collection date for primary outcome measure)
Best spectacle corrected visual acuity [ Time Frame: 1998 - 2018 ] [ Designated as safety issue: No ]
Best spectacle corrected visual acuity [ Time Frame: 1998 - 2018 ]
Complete list of historical versions of study NCT00543660 on ClinicalTrials.gov Archive Site
Corneal endothelial cell density [ Time Frame: 1998-2018 ] [ Designated as safety issue: No ]
Corneal endothelial cell density [ Time Frame: 1998-2018 ]
Not Provided
Not Provided
 
Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)
Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)

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).

Please see above.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Corneal Dystrophies, Hereditary
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
Experimental: Intervention arm DSEK
Intervention: DSEK
Intervention: Procedure: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Melles GR. Posterior lamellar keratoplasty: DLEK to DSEK to DMEK. Cornea. 2006 Sep;25(8):879-81.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
March 2018
March 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Corneal endothelial disorders

Exclusion Criteria:

  • N/A
Both
21 Years and older
No
Contact: Gerrit RJ Melles, MD PhD 31 10 297 4444 melles@niioc.nl
Contact: Kim Herders, MSc 31 10 297 4444 herders@niios.com
Netherlands
 
NCT00543660
NIIOS.1998.04
Yes
GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery
Netherlands Institute for Innovative Ocular Surgery
  • Amnitrans Eyebank Rotterdam
  • Melles CorneaClinic Rotterdam
Principal Investigator: Gerrit RJ Melles, MD PhD Netherlands Institute for Innovative Ocular Surgery
Netherlands Institute for Innovative Ocular Surgery
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP