Back to resultsTechnique And Results In Endothelial Keratoplasty (TREK)
Primary Purpose
Corneal Endothelial Cell Loss, Fuchs' Endothelial Dystrophy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Descemet Stripping Automated Endothelial Keratoplasty
Descemet Membrane Endothelial Keratoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Endothelial Cell Loss focused on measuring Corneal Endothelial Cell Loss, Fuchs' Endothelial Dystrophy, Lamellar Keratoplasty, Descemet Stripping Endothelial Keratoplasty, Descemet Membrane Endothelial Keratoplasty, Minimal Surgical Procedure
Eligibility Criteria
Inclusion Criteria:
- Diagnosis with corneal endothelial dysfunction requiring lamellar endothelial corneal transplantation.
- Free acceptance to be enrolled in the trial, and signature of the informed consent by the subject and/or its legal representatives.
Exclusion Criteria:
N/A
Sites / Locations
- Hospital Universitari Mutua Terrassa
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
DSAEK group
DMEK group
Arm Description
Subjects operated of Descemet Stripping Automated Endothelial Keratoplasty.
Subjects operated of Descemet Membrane Endothelial Keratoplasty.
Outcomes
Primary Outcome Measures
Visual acuity
Secondary Outcome Measures
Endothelial cell density
Intraoperative complications
Postoperative complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02470793
Brief Title
Technique And Results In Endothelial Keratoplasty
Acronym
TREK
Official Title
Technique And Results Evaluation In Endothelial Keratoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
January 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
EDUARD PEDEMONTE-SARRIAS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess and compare the complications and results of different lamellar endothelial keratoplasty techniques and its variations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Endothelial Cell Loss, Fuchs' Endothelial Dystrophy
Keywords
Corneal Endothelial Cell Loss, Fuchs' Endothelial Dystrophy, Lamellar Keratoplasty, Descemet Stripping Endothelial Keratoplasty, Descemet Membrane Endothelial Keratoplasty, Minimal Surgical Procedure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DSAEK group
Arm Type
Active Comparator
Arm Description
Subjects operated of Descemet Stripping Automated Endothelial Keratoplasty.
Arm Title
DMEK group
Arm Type
Experimental
Arm Description
Subjects operated of Descemet Membrane Endothelial Keratoplasty.
Intervention Type
Procedure
Intervention Name(s)
Descemet Stripping Automated Endothelial Keratoplasty
Other Intervention Name(s)
DSAEK, DSEK
Intervention Description
Descemet Stripping Automated Endothelial Keratoplasty
Intervention Type
Procedure
Intervention Name(s)
Descemet Membrane Endothelial Keratoplasty
Other Intervention Name(s)
DMEK
Intervention Description
Descemet Membrane Endothelial Keratoplasty
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
First six months postoperatively
Secondary Outcome Measure Information:
Title
Endothelial cell density
Time Frame
First six months postoperatively
Title
Intraoperative complications
Time Frame
First six months postoperatively
Title
Postoperative complications
Time Frame
First six months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis with corneal endothelial dysfunction requiring lamellar endothelial corneal transplantation.
Free acceptance to be enrolled in the trial, and signature of the informed consent by the subject and/or its legal representatives.
Exclusion Criteria:
N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduard Pedemonte-Sarrias, MD
Organizational Affiliation
Hospital Universitari Mútua Terrassa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Mutua Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Technique And Results In Endothelial Keratoplasty
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