Technique And Results In Endothelial Keratoplasty (TREK)

March 9, 2021 updated by: EDUARD PEDEMONTE-SARRIAS

Technique And Results Evaluation In Endothelial Keratoplasty

To assess and compare the complications and results of different lamellar endothelial keratoplasty techniques and its variations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

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

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitari Mútua Terrassa

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: First six months postoperatively
First six months postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Endothelial cell density
Time Frame: First six months postoperatively
First six months postoperatively
Intraoperative complications
Time Frame: First six months postoperatively
First six months postoperatively
Postoperative complications
Time Frame: First six months postoperatively
First six months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EDUARD PEDEMONTE-SARRIAS

Investigators

  • Principal Investigator: Eduard Pedemonte-Sarrias, MD, Hospital Universitari Mútua Terrassa

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 (Actual)

September 1, 2014

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

June 6, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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