Post Operative Visual Acuity for DSAEK and UT-DSAEK | NCT03685851

Studies
Post Operative Visual Acuity for DSAEK and UT-DSAEK

NCT03685851

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Last Update Posted

Oct 11, 2018Actual

Enrollment

111Actual

Phase

Not provided

Conditions

Corneal Transplant

Interventions

DSAEK type corneal transplant

Countries

Not provided

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

Sep 2018

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

Feb 1, 2012Actual

Primary Completion Date

Apr 1, 2015Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Sep 25, 2018

First Submission Date that Met QC Criteria

Sep 25, 2018

First Posted Date

Sep 26, 2018Actual

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

Oct 9, 2018

Last Update Posted Date

Oct 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 study the correlation between graft size in DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) and UT (ultra thin)-DSAEK type corneal transplants to the visual acuity 6 months postoperatively.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

111Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UT-DSAEK		With graft 6 months thick less than 100 µm	Procedure: DSAEK type corneal transplant
DSAEK		With graft thicker than 100 µm	Procedure: DSAEK type corneal transplant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DSAEK type corneal transplant	Procedure	All surgeries were performed by the same surgeon and according to the same protocol	DSAEK UT-DSAEK

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative visual acuity	postoperative visual acuity in logmar	Month 6

Secondary Outcomes

Measure	Description	Time Frame
Pachymetry	Measurement of the thickness of the cornea	Month 6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent DSAEK surgery
Patients in department of ophthalmology between february 2012 and june 2017

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who underwent DSAEK surgery between february 2012 and june 2017

Sampling Method

Non-Probability Sample