Technique And Results In Endothelial Keratoplasty

NCT ID: NCT02470793

Last Updated: 2021-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2021-01-31

Brief Summary

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

Detailed Description

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Conditions

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Corneal Endothelial Cell Loss Fuchs' Endothelial Dystrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DSAEK group

Subjects operated of Descemet Stripping Automated Endothelial Keratoplasty.

Group Type ACTIVE_COMPARATOR

Descemet Stripping Automated Endothelial Keratoplasty

Intervention Type PROCEDURE

Descemet Stripping Automated Endothelial Keratoplasty

DMEK group

Subjects operated of Descemet Membrane Endothelial Keratoplasty.

Group Type EXPERIMENTAL

Descemet Membrane Endothelial Keratoplasty

Intervention Type PROCEDURE

Descemet Membrane Endothelial Keratoplasty

Interventions

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Descemet Stripping Automated Endothelial Keratoplasty

Descemet Stripping Automated Endothelial Keratoplasty

Intervention Type PROCEDURE

Descemet Membrane Endothelial Keratoplasty

Descemet Membrane Endothelial Keratoplasty

Intervention Type PROCEDURE

Other Intervention Names

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DSAEK DSEK DMEK

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EDUARD PEDEMONTE-SARRIAS

OTHER

Sponsor Role lead

Responsible Party

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EDUARD PEDEMONTE-SARRIAS

MEDICAL DOCTOR

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Eduard Pedemonte-Sarrias, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Mútua Terrassa

Locations

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Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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00001

Identifier Type: -

Identifier Source: org_study_id

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