Technique And Results In Endothelial Keratoplasty

Overview

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

Full Title of Study: “Technique And Results Evaluation In Endothelial Keratoplasty”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2025

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: DSAEK group
    • Subjects operated of Descemet Stripping Automated Endothelial Keratoplasty.
  • Experimental: DMEK group
    • Subjects operated of Descemet Membrane Endothelial Keratoplasty.

Clinical Trial Outcome Measures

Primary Measures

  • Visual acuity
    • Time Frame: First six months postoperatively

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EDUARD PEDEMONTE-SARRIAS
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: EDUARD PEDEMONTE-SARRIAS, MEDICAL DOCTOR – Hospital Mutua de Terrassa
  • Overall Official(s)
    • Eduard Pedemonte-Sarrias, MD, Principal Investigator, Hospital Universitari MĂștua Terrassa
  • Overall Contact(s)
    • Eduard Pedemonte-Sarrias, MD, (+34)937365050, epedemonte@mutuaterrassa.com

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