Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
Primary Purpose
Fuchs' Endothelial Dystrophy, Bullous Keratopathy
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intraocular gas
Sponsored by
About this trial
This is an interventional treatment trial for Fuchs' Endothelial Dystrophy focused on measuring Intraocular gas, Positioning, DMEK, Endothelial keratoplasty
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
Sites / Locations
- Glostrup Hospital, University of CopenhagenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Air
SF6
Arm Description
Intraocular 100% atmospheric air (anterior chamber).
Intraocular 20% sulphur hexaflouride (anterior chamber).
Outcomes
Primary Outcome Measures
Graft detachment
Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT.
Secondary Outcome Measures
Visual acuity
Snellen chart (logMAR)
Gas fill
Postoperative gas fill measured by OCT.
Positioning
Pitch and roll of head using positioning device
Complications
Any adverse outcome affecting the eye
Full Information
NCT ID
NCT03407755
First Posted
January 15, 2018
Last Updated
February 14, 2019
Sponsor
Glostrup University Hospital, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT03407755
Brief Title
Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
Official Title
Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Dystrophy, Bullous Keratopathy
Keywords
Intraocular gas, Positioning, DMEK, Endothelial keratoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients randomized to either air or sulfur hexafluoride (SF6)
Masking
ParticipantInvestigator
Masking Description
Surgeon and patient masked to choice of intraocular gas. Study coordinator not masked.
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Air
Arm Type
Active Comparator
Arm Description
Intraocular 100% atmospheric air (anterior chamber).
Arm Title
SF6
Arm Type
Experimental
Arm Description
Intraocular 20% sulphur hexaflouride (anterior chamber).
Intervention Type
Procedure
Intervention Name(s)
Intraocular gas
Intervention Description
Participants randomized to either air or SF6 gas in the anterior chamber.
Primary Outcome Measure Information:
Title
Graft detachment
Description
Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT.
Time Frame
Occurence within 3 months postoperative
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Snellen chart (logMAR)
Time Frame
3 months postoperative
Title
Gas fill
Description
Postoperative gas fill measured by OCT.
Time Frame
Serial measurements during postoperative week 1.
Title
Positioning
Description
Pitch and roll of head using positioning device
Time Frame
72 hours postoperative
Title
Complications
Description
Any adverse outcome affecting the eye
Time Frame
Occurence within 3 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Alberti, MD
Phone
+4538634823
Email
malb0038@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Alberti, MD
Organizational Affiliation
Rigshospitalet - Glostrup
Official's Role
Study Director
Facility Information:
Facility Name
Glostrup Hospital, University of Copenhagen
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Alberti
Email
mark.jensen.alberti@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
If permitted by the Danish Data Protection Agency
Learn more about this trial
Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
We'll reach out to this number within 24 hrs