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Technique And Results In Endothelial Keratoplasty (TREK)

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ClinicalTrials.gov Identifier: NCT02470793
Recruitment Status : Recruiting
First Posted : June 12, 2015
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
EDUARD PEDEMONTE-SARRIAS, Hospital Mutua de Terrassa

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
Corneal Endothelial Cell Loss Fuchs' Endothelial Dystrophy Procedure: Descemet Stripping Automated Endothelial Keratoplasty Procedure: Descemet Membrane Endothelial Keratoplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Technique And Results Evaluation In Endothelial Keratoplasty
Study Start Date : September 2014
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


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 Name: DMEK




Primary Outcome Measures :
  1. Visual acuity [ Time Frame: First six months postoperatively ]

Secondary Outcome Measures :
  1. Endothelial cell density [ Time Frame: First six months postoperatively ]
  2. Intraoperative complications [ Time Frame: First six months postoperatively ]
  3. Postoperative complications [ Time Frame: First six months postoperatively ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470793


Contacts
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Contact: Eduard Pedemonte-Sarrias, MD (+34)937365050 ext 3400 epedemonte@mutuaterrassa.com

Locations
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Spain
Hospital Universitari Mutua Terrassa Recruiting
Terrassa, Barcelona, Spain, 08221
Sponsors and Collaborators
EDUARD PEDEMONTE-SARRIAS
Investigators
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Principal Investigator: Eduard Pedemonte-Sarrias, MD Hospital Universitari Mútua Terrassa

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Responsible Party: EDUARD PEDEMONTE-SARRIAS, MEDICAL DOCTOR, Hospital Mutua de Terrassa
ClinicalTrials.gov Identifier: NCT02470793     History of Changes
Other Study ID Numbers: 00001
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by EDUARD PEDEMONTE-SARRIAS, 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:
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Fuchs' Endothelial Dystrophy
Corneal Endothelial Cell Loss
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Postoperative Complications
Pathologic Processes