NCT02470793

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

6.3 years

First QC Date

June 6, 2015

Last Update Submit

March 9, 2021

Conditions

Corneal Endothelial Cell LossFuchs' Endothelial Dystrophy

Keywords

Corneal Endothelial Cell LossFuchs' Endothelial DystrophyLamellar KeratoplastyDescemet Stripping Endothelial KeratoplastyDescemet Membrane Endothelial KeratoplastyMinimal Surgical Procedure

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    First six months postoperatively

Secondary Outcomes (3)

  • Endothelial cell density

    First six months postoperatively

  • Intraoperative complications

    First six months postoperatively

  • Postoperative complications

    First six months postoperatively

Study Arms (2)

DSAEK group

ACTIVE COMPARATOR

Subjects operated of Descemet Stripping Automated Endothelial Keratoplasty.

Procedure: Descemet Stripping Automated Endothelial Keratoplasty

DMEK group

EXPERIMENTAL

Subjects operated of Descemet Membrane Endothelial Keratoplasty.

Procedure: Descemet Membrane Endothelial Keratoplasty

Interventions

Descemet Stripping Automated Endothelial KeratoplastyPROCEDURE

Descemet Stripping Automated Endothelial Keratoplasty

Also known as: DSAEK, DSEK
DSAEK group
Descemet Membrane Endothelial KeratoplastyPROCEDURE

Descemet Membrane Endothelial Keratoplasty

Also known as: DMEK
DMEK group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis with corneal endothelial dysfunction requiring lamellar endothelial corneal transplantation.
  • Free acceptance to be enrolled in the trial, and signature of the informed consent by the subject and/or its legal representatives.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

Location

MeSH Terms

Conditions

Corneal Endothelial Cell LossFuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsCorneal Dystrophies, HereditaryEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Eduard Pedemonte-Sarrias, MD

    Hospital Universitari Mútua Terrassa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MEDICAL DOCTOR

Study Record Dates

First Submitted

June 6, 2015

First Posted

June 12, 2015

Study Start

September 1, 2014

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

March 11, 2021

Record last verified: 2021-03

Locations

ES(1)