DMEK And Cataract Surgery: Comparison Of Sequential Versu... | NCT03355924

Studies
DMEK And Cataract Surgery: Comparison Of Sequential Versus Combined Procedure

NCT03355924

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Last Update Posted

Aug 24, 2023Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Cataract
Corneal Graft

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

Nov 2017

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

Nov 1, 2016Actual

Primary Completion Date

May 30, 2017Actual

Completion Date

May 30, 2017Actual

First Submitted Date

Nov 23, 2017

First Submission Date that Met QC Criteria

Nov 23, 2017

First Posted Date

Nov 28, 2017Actual

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

Aug 23, 2023

Last Update Posted Date

Aug 24, 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

The aim of this study is to describe the outcomes of phaco-DMEK (Descemet Membrane Endothelial Keratoplasty ) according to a sequential versus a combined procedure

Detailed Description

The study included patients who underwent DMEK combined or not with cataract surgery between January 2014 and march 2016. Were excluded patients with other ocular comorbidity, and those who had graft after a first graft failure. The main outcome was BVCA measured at one year. The post-operative follow up was down at D7, M1, M3, M6, and M12. Secondary outcomes were; the mean time to visual recovery and influence of the delay between cataract removal and DMEK.

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

31Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best visual acuity	logMar	Month 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who underwent DMEK combined or not with cataract surgery

Exclusion Criteria:

patients with other ocular comorbidity, and those who had graft after a first graft failure

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 underwent DMEK combined or not with cataract surgery

Sampling Method

Non-Probability Sample

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases