Pratical Assessment of DSAEK in the Management of Endothe... | NCT03687996

Studies
Pratical Assessment of DSAEK in the Management of Endothelial Decompensation Following Penetrating Keratoplasty

NCT03687996

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Last Update Posted

Feb 3, 2023Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Descemet's Stripping Automated Endothelial Keratoplasty

Interventions

Not provided

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

Feb 2023

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

Jan 1, 2015Actual

Primary Completion Date

Dec 1, 2015Actual

Completion Date

Jul 31, 2016Actual

First Submitted Date

Sep 25, 2018

First Submission Date that Met QC Criteria

Sep 26, 2018

First Posted Date

Sep 27, 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

Feb 1, 2023

Last Update Posted Date

Feb 3, 2023Actual

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

Reporting our anatomical and functional results and the possible complications of the first six Descemet's stripping endothelial keratoplasty (DSAEK) performed in our department secondary to endothelial decompensation after penetrating keratoplasty.

Detailed Description

A retrospective and observational monocentric study fo six patients with DSAEK after prior penetrating keratoplasty (PK). The data collected are: demographic characteristics, ophthalmological comorbidities, initial indication of PK, delay between PK and DSAEK. Preoperative Visual Acuity and at 1, 3 and 6 months postoperative were collected in logmar for analysis. The central cornea and graft thickness measured in OCT as well as the postoperative complications were also collected.

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

6Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual acuity	pre and postoperative visual acuity in logmar	change from visual acuity at 6 month

Secondary Outcomes

Measure	Description	Time Frame
cornea thickness at 6 months	the central cornea and graft thickness measured in OCT	change from cornea thickness at 6 months
cornea thickness at 10 years	the central cornea and graft thickness measured in OCT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

with endothelial decompensation after penetrating keratoplasty
surgery realised by the same surgeon

Exclusion Criteria:

None

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

Patients who profited of the first Descemet's stripping endothelial keratoplasty to endothelial decompensation after penetrating keratoplasty

Sampling Method

Non-Probability Sample