Technique And Results In Endothelial Keratoplasty

Not Applicable

Completed

• Conditions: Fuchs' Endothelial Dystrophy; Corneal Endothelial Cell Loss
• Interventions: Procedure: Descemet Stripping Automated Endothelial Keratoplasty; Procedure: Descemet Membrane Endothelial Keratoplasty

• Registration Number: NCT02470793
• Lead Sponsor: EDUARD PEDEMONTE-SARRIAS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-06-06
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-12
• Primary Completion: 2021-01
• Study Completion: 2021-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DSAEK group	Descemet Stripping Automated Endothelial Keratoplasty	Subjects operated of Descemet Stripping Automated Endothelial Keratoplasty.
DMEK group	Descemet Membrane Endothelial Keratoplasty	Subjects operated of Descemet Membrane Endothelial Keratoplasty.

Primary Outcome Measures

Name	Time	Method
Visual acuity	First six months postoperatively

Secondary Outcome Measures

Name	Time	Method
Endothelial cell density	First six months postoperatively
Intraoperative complications	First six months postoperatively
Postoperative complications	First six months postoperatively

Trial Locations

Locations (1)

Hospital Universitari Mutua Terrassa; 🇪🇸 Terrassa, Barcelona, Spain