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

Primary Purpose

Corneal Dystrophies, Hereditary

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Sponsored by
Netherlands Institute for Innovative Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Dystrophies, Hereditary focused on measuring Corneal transplantation, Descemet membrane, endothelium

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Corneal endothelial disorders

Exclusion Criteria:

  • N/A

Sites / Locations

  • Netherlands Institute for Innovative Ocular Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm DSEK

Arm Description

Intervention: DSEK

Outcomes

Primary Outcome Measures

Best spectacle corrected visual acuity

Secondary Outcome Measures

Corneal endothelial cell density

Full Information

First Posted
October 11, 2007
Last Updated
January 11, 2023
Sponsor
Netherlands Institute for Innovative Ocular Surgery
Collaborators
Amnitrans Eyebank Rotterdam, Melles CorneaClinic Rotterdam
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1. Study Identification

Unique Protocol Identification Number
NCT00543660
Brief Title
Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)
Acronym
DSAEK
Official Title
Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Netherlands Institute for Innovative Ocular Surgery
Collaborators
Amnitrans Eyebank Rotterdam, Melles CorneaClinic Rotterdam

4. Oversight

Data Monitoring Committee
Yes

5. 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).
Detailed Description
Please see above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Dystrophies, Hereditary
Keywords
Corneal transplantation, Descemet membrane, endothelium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm DSEK
Arm Type
Experimental
Arm Description
Intervention: DSEK
Intervention Type
Procedure
Intervention Name(s)
Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Other Intervention Name(s)
Descemet Stripping Endothelial Keratoplasty (DSEK), Please see www.niios.com
Primary Outcome Measure Information:
Title
Best spectacle corrected visual acuity
Time Frame
1998 - 2018
Secondary Outcome Measure Information:
Title
Corneal endothelial cell density
Time Frame
1998-2018

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Corneal endothelial disorders Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerrit RJ Melles, MD PhD
Organizational Affiliation
Netherlands Institute for Innovative Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Netherlands Institute for Innovative Ocular Surgery
City
Rotterdam
ZIP/Postal Code
3071 AA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
17102659
Citation
Melles GR. Posterior lamellar keratoplasty: DLEK to DSEK to DMEK. Cornea. 2006 Sep;25(8):879-81. doi: 10.1097/01.ico.0000243962.60392.4f. No abstract available.
Results Reference
result

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

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