TREK: Technique And Results In Endothelial Keratoplasty
Sponsor
EDUARD PEDEMONTE-SARRIAS (Other)
Overall Status
Completed
CT.gov ID
NCT02470793
Collaborator
(none)
62
1
2
76
0.8
Study Details
Study Description
Brief Summary
To assess and compare the complications and results of different lamellar endothelial keratoplasty techniques and its variations.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
62 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Technique And Results Evaluation In Endothelial Keratoplasty
Actual Study Start Date
:
Sep 1, 2014
Actual Primary Completion Date
:
Jan 1, 2021
Actual Study Completion Date
:
Jan 1, 2021
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: DSAEK group Subjects operated of Descemet Stripping Automated Endothelial Keratoplasty. |
Procedure: Descemet Stripping Automated Endothelial Keratoplasty
Descemet Stripping Automated Endothelial Keratoplasty
Other Names:
|
Experimental: DMEK group Subjects operated of Descemet Membrane Endothelial Keratoplasty. |
Procedure: Descemet Membrane Endothelial Keratoplasty
Descemet Membrane Endothelial Keratoplasty
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Visual acuity [First six months postoperatively]
Secondary Outcome Measures
- Endothelial cell density [First six months postoperatively]
- Intraoperative complications [First six months postoperatively]
- Postoperative complications [First six months postoperatively]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hospital Universitari Mutua Terrassa | Terrassa | Barcelona | Spain | 08221 |
Sponsors and Collaborators
- EDUARD PEDEMONTE-SARRIAS
Investigators
- Principal Investigator: Eduard Pedemonte-Sarrias, MD, Hospital Universitari MĂștua Terrassa
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
EDUARD PEDEMONTE-SARRIAS,
MEDICAL DOCTOR,
Hospital Mutua de Terrassa
ClinicalTrials.gov Identifier:
NCT02470793
Other Study ID Numbers:
- 00001
First Posted:
Jun 12, 2015
Last Update Posted:
Mar 11, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by EDUARD PEDEMONTE-SARRIAS,
MEDICAL DOCTOR,
Hospital Mutua de Terrassa
Additional relevant MeSH terms: