Technique And Results In Endothelial Keratoplasty | NCT02470793

Studies
Technique And Results In Endothelial Keratoplasty

NCT02470793

Sponsor

EDUARD PEDEMONTE-SARRIAS

Status

Completed

Last Update Posted

Mar 11, 2021Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Corneal Endothelial Cell Loss
Fuchs' Endothelial Dystrophy

Interventions

Descemet Stripping Automated Endothelial Keratoplasty
Descemet Membrane Endothelial Keratoplasty

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014Actual

Primary Completion Date

Jan 2021Actual

Completion Date

Jan 2021Actual

First Submitted Date

Jun 6, 2015

First Submission Date that Met QC Criteria

Jun 11, 2015

First Posted Date

Jun 12, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2021

Last Update Posted Date

Mar 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Conditions Module

Conditions

Corneal Endothelial Cell Loss
Fuchs' Endothelial Dystrophy

Keywords

Corneal Endothelial Cell Loss
Fuchs' Endothelial Dystrophy
Lamellar Keratoplasty
Descemet Stripping Endothelial Keratoplasty
Descemet Membrane Endothelial Keratoplasty
Minimal Surgical Procedure

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Descemet Stripping Automated Endothelial Keratoplasty	Procedure	Descemet Stripping Automated Endothelial Keratoplasty	DSAEK group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity		First six months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Endothelial cell density		First six months postoperatively
Intraoperative complications		First six months postoperatively
Postoperative complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

N/A

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eduard Pedemonte-Sarrias, MD	Hospital Universitari Mútua Terrassa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari Mutua Terrassa		Terrassa	Barcelona	08221	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055954	Corneal Endothelial Cell Loss
D005642	Fuchs' Endothelial Dystrophy

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases
D005132	Eye Manifestations
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided