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TREK: Technique And Results In Endothelial Keratoplasty

Sponsor
EDUARD PEDEMONTE-SARRIAS (Other)
Overall Status
Completed
CT.gov ID
NCT02470793
Collaborator
(none)
62
Enrollment
1
Location
2
Arms
76
Actual Duration (Months)
0.8
Patients Per Site Per Month

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
  • Procedure: Descemet Stripping Automated Endothelial Keratoplasty
  • Procedure: Descemet Membrane Endothelial Keratoplasty
 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:
  • DSAEK
  • DSEK

    		•
    Experimental: DMEK group

    Subjects operated of Descemet Membrane Endothelial Keratoplasty.

    Procedure: Descemet Membrane Endothelial Keratoplasty
    Descemet Membrane Endothelial Keratoplasty
    Other Names:
  • DMEK

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [First six months postoperatively]

    Secondary Outcome Measures

    1. Endothelial cell density [First six months postoperatively]

    2. Intraoperative complications [First six months postoperatively]

    3. 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:

    1. Diagnosis with corneal endothelial dysfunction requiring lamellar endothelial corneal transplantation.

    2. 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 Mútua 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
    Corneal Endothelial Cell Loss
    Fuchs' Endothelial Dystrophy
    Lamellar Keratoplasty
    Descemet Stripping Endothelial Keratoplasty
    Descemet Membrane Endothelial Keratoplasty
    Minimal Surgical Procedure
    Additional relevant MeSH terms:
    Fuchs' Endothelial Dystrophy
    Corneal Endothelial Cell Loss

    Study Results

    No Results Posted as of Mar 11, 2021