- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00543660
Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK) (DSAEK)
January 11, 2023 updated by: GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Please see above.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rotterdam, Netherlands, 3071 AA
- Netherlands Institute for Innovative Ocular Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Corneal endothelial disorders
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention arm DSEK
Intervention: DSEK
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Best spectacle corrected visual acuity
Time Frame: 1998 - 2018
|
1998 - 2018
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Corneal endothelial cell density
Time Frame: 1998-2018
|
1998-2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gerrit RJ Melles, MD PhD, Netherlands Institute for Innovative Ocular Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 1998
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
October 11, 2007
First Submitted That Met QC Criteria
October 11, 2007
First Posted (Estimate)
October 15, 2007
Study Record Updates
Last Update Posted (Actual)
January 12, 2023
Last Update Submitted That Met QC Criteria
January 11, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIIOS.1998.04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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