Air Versus SF6 for Descemet's Membrane Endothelial Kerato... | NCT03407755

Studies
Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)

NCT03407755

Sponsor

Glostrup University Hospital, Copenhagen

Status

Unknown status

Last Update Posted

Feb 15, 2019Actual

Enrollment

104Estimated

Phase

Not Applicable

Conditions

Fuchs' Endothelial Dystrophy
Bullous Keratopathy

Interventions

Intraocular gas

Countries

Denmark

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 2019

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

Sep 15, 2017Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

May 1, 2020Estimated

First Submitted Date

Jan 15, 2018

First Submission Date that Met QC Criteria

Jan 15, 2018

First Posted Date

Jan 23, 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 14, 2019

Last Update Posted Date

Feb 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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

104Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Air	Active Comparator	Intraocular 100% atmospheric air (anterior chamber).	Procedure: Intraocular gas
SF6	Experimental	Intraocular 20% sulphur hexaflouride (anterior chamber).	Procedure: Intraocular gas

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraocular gas	Procedure	Participants randomized to either air or SF6 gas in the anterior chamber.	Air SF6

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Graft detachment	Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT.	Occurence within 3 months postoperative

Secondary Outcomes

Measure	Description	Time Frame
Visual acuity	Snellen chart (logMAR)	3 months postoperative
Gas fill	Postoperative gas fill measured by OCT.	Serial measurements during postoperative week 1.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Eligible for DMEK surgey

Exclusion Criteria:

Related to ocular health

Re-DMEK or prior penetrating keratoplasty
Ocular hypertension resistant to topical medication
Previous vitrectomy
Minimally invasive glaucoma devices
Aphakia
Anterior chamber or iris claw lens
Implantable Collamer Lens (ICL)
Clinically significant corneal scarring
Central corneal thickness >750 µm
BCVA < 0.1

Related to general health

Not able to give informed consent
Inability to position correctly due to organic or psychological condition.

Related to surgical procedure

Graft diameter >9 mm or < 7mm
Graft central endothelial cell count < 2000 cells/mm2
Graft unfolding duration >1 hour
Graft morphology grade 4-5
Significant graft decentration (graft contour not visible in microscope)
Significant presence of Descemet remnants in the graft-host interface
Presence of inward folds
Graft 'stroma-surface' placed facing away from recipient stroma

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

Name	Role	Phone	Extension	Email
Mark Alberti, MD	Contact	+4538634823		malb0038@regionh.dk

Overall Officials

Name	Affiliation	Role
Mark Alberti, MD	Glostrup University Hospital, Copenhagen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glostrup Hospital, University of Copenhagen	Recruiting	Glostrup Municipality		2600	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

If permitted by the Danish Data Protection Agency

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005642	Fuchs' Endothelial Dystrophy

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