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

Sponsor
Netherlands Institute for Innovative Ocular Surgery (Other)
Overall Status
Unknown status
CT.gov ID
NCT00543660
Collaborator
Amnitrans Eyebank Rotterdam (Other), Melles CorneaClinic Rotterdam (Other)
1,000
Enrollment
1
Location
1
Arm
240
Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
 N/A

Detailed Description

Please see above.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)
Study Start Date :
Mar 1, 1998
Anticipated Primary Completion Date :
Mar 1, 2018
Anticipated Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Best spectacle corrected visual acuity [1998 - 2018]

    Secondary Outcome Measures

    1. Corneal endothelial cell density [1998-2018]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Corneal endothelial disorders
    Exclusion Criteria:
    • N/A

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Netherlands Institute for Innovative Ocular Surgery Rotterdam Netherlands 3071 AA

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GRJ Melles, MD, PhD, Director, Netherlands Institute for Innovative Ocular Surgery
    ClinicalTrials.gov Identifier:
    NCT00543660
    Other Study ID Numbers:
    • NIIOS.1998.04
    First Posted:
    Oct 15, 2007
    Last Update Posted:
    Mar 29, 2018
    Last Verified:
    Mar 1, 2018
    Keywords provided by GRJ Melles, MD, PhD, Director, Netherlands Institute for Innovative Ocular Surgery
    Corneal transplantation, Descemet membrane, endothelium
    Additional relevant MeSH terms:
    Corneal Dystrophies, Hereditary

    Study Results

    No Results Posted as of Mar 29, 2018