The Postoperative Head Position as a Predictor of the Sur... | NCT04387331

Studies
The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK

NCT04387331

Sponsor

Peter Wiedemann

Status

Unknown status

Last Update Posted

May 13, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Fuchs Endothelial Corneal Dystrophy
Pseudophakic Bullous Keratopathy
Chemical Burn of Cornea
Posterior Polymorphous Corneal Dystrophy

Interventions

Not provided

Countries

Germany

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

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 11, 2020Actual

Primary Completion Date

Jun 2021Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

May 7, 2020

First Submission Date that Met QC Criteria

May 12, 2020

First Posted Date

May 13, 2020Actual

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

May 12, 2020

Last Update Posted Date

May 13, 2020Actual

Name	Class
Institut für Angewandte Trainingswissenschaft	UNKNOWN

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

This study aims to investigate the influence of postoperative head position on clinical outcomes after DMEK via a wearable sensor.

Detailed Description

After Descemet Membrane Endothelial Keratoplasty (DMEK) patients are recommended to keep a strict supine position within the first few days after surgery in order to attach the graft to the corneal stroma. It has not yet been investigated to what extent the head position actually has an effect on the outcome.

In this study, the participants head position will be continuously monitored within the first three days after DMEK. Participants wear a headband in which a small sensor is inserted. The degree of deviation from the neutral position will then be correlated with clinical outcomes.

Conditions Module

Conditions

Fuchs Endothelial Corneal Dystrophy
Pseudophakic Bullous Keratopathy
Chemical Burn of Cornea
Posterior Polymorphous Corneal Dystrophy

Keywords

Descemet Membrane Endothelial Keratoplasty
DMEK
Fuchs Endothelial Corneal Dystrophy
Pseudophakic Bullous Keratopathy
Chemical Burn of Cornea
Posterior Polymorphous Corneal Dystrophy
Postoperative Head Position
Corneal Transplantation
Head Tracking Sensor

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

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corneal Endothelial Cell Density	measured in cells/mm2	three months after surgery

Secondary Outcomes

Measure	Description	Time Frame
Best Corrected Visual Acuity	measured in logMAR	prior to surgery, three and six months after surgery
Central Corneal Thickness	measured in μm

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients undergoing DMEK

Exclusion Criteria:

no specific exclusion criteria

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

All patients with Descemet Membrane Endothelial Keratoplasty during the study are offered to participate.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christian Girbardt, MD	Contact	00493419721668		christian.girbardt@medizin.uni-leipzig.de
Louise Kühne	Contact			louise.kuehne@medizin.uni-leipzig.de

Overall Officials

Name	Affiliation	Role
Peter Wiedemann, MD	University of Leipzig	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leipzig University Hospital, Department of Ophthalmology	Recruiting	Leipzig	Saxony	04103	Germany

Condition Browse Module

MeSH Terms

ID	Term
D005642	Fuchs' Endothelial Dystrophy
C562745	Corneal Dystrophy, Posterior Polymorphous, 1

Ancestor Terms

ID	Term
D003317	Corneal Dystrophies, Hereditary
D003316	Corneal Diseases
D005128	Eye Diseases
D015785	Eye Diseases, Hereditary

Browse Leaves

Not provided

Browse Branches

Not provided